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2011 Quality and Regulatory News

PDA's Regulatory News is a source of pertinent news from all over the globe. This section is set up by distinct parts of the world so you can read what is crucial to you and your company.

North America News

Collection of Information Available on U.S. FDA’s Recall Regulations

November 29, 2011

The U.S. FDA is asking the industry to comment on a proposed collection of information related to FDA's Recall Regulations.

Specifically, the Agency is seeking comments on the estimated annual burden hours for firms to comply with the voluntary reporting requirements of its recall regulations.

Comments should be submitted by December 23.

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U.S. FDA Extends Comment Period on Device Modifications Draft Guide

November 9, 2011

The U.S. FDA is closing will now close the comment period on the draft guidance, Draft Guidance for Industry and Food and Drug Administration Staff; 510(k)Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device on November 28th.

The notice first appeared in the July 27 Federal Register. The Agency is taking this action to allow interested persons additional time to submit comments.

Read more

Retrospective Review of Bar Code Technologies for Drugs and Biological Products

October 25, 2011

The U.S. FDA has announced a review of the ‘‘Bar Code Final Rule,” under Executive Order 13563, ‘‘Improving Regulation and Regulatory Review.’’

The Bar Code Final Rule, which was published in 2004, requires certain human drug products and biological products to have a bar code. Information submitted can help FDA to reassess the costs and benefits of the rule and to identify any relevant changes in technology that have occurred since it went into effect.

Initial comments must be received on or before January 9, 2012

Read more

U.S. FDA Draft Docs Supporting eCTD submissions Available

October 25, 2011

The U.S. FDA is announcing the availability of the following draft versions of documents that support making regulatory submissions in electronic format using the electronic Common Technical Document (eCTD) specifications entitled ‘‘The eCTD Backbone Files Specification for Module 1, version 2.0’’ (which includes the U.S. regional document type definition, version 3.0) and ‘‘Comprehensive Table of Contents Headings and Hierarchy, version 2.0.’’ Supporting technical files are also being made available on the Agency website.

These draft documents represent FDA’s major updates to Module 1 of the eCTD, which contains regional information.

Submit comments on the draft documents by December 27.

Read more

Anticipated Progress of Q3D and Q11 at ICH Meeting in Spain Outlined at U.S. FDA Public Meeting

October 25, 2011

In order to solicit public input prior to the next steering committee and expert working group meeting in Seville, Spain, the U.S. FDA held a public meeting on October 25.

During the meeting, the regulators told the audience that Q11 was on track and is expected to reach step 4 by the end of the ICH meeting in November. Q3D was also discussed and the regulators are looking to have a complete pre-step 2 document by the end of the meeting in Seville.

Comment on U.S. FDA’s Transparency Draft Proposals

October 14, 2011

The U.S. FDA is allowing the public to comment on FDA draft proposals that will increase transparency by promoting greater access to the Agency’s compliance and enforcement data.

The proposals address ways to make FDA’s compliance and enforcement data more accessible and user-friendly.

Comment by December 2.

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U.S. FDA to Hold Public Meeting in Advance of ICH Meeting in November

October 14, 2011

The U. S. FDA has announced that it will be holding a public meeting entitled “Preparation for ICH Steering Committee and Expert Working Group Meetings in Seville, Spain” on October 25.

The purpose of the meeting is to solicit public input prior to the next ICH Steering Committee and Expert Working Group meetings on November 5 – 10.

Preregistration is required by October 21.

Read more

U.S. FDA Guidance Available on Labeling Content and Format

October 14, 2011

A U.S. FDA guidance is available on the labeling content and format of human prescription drug and biological products.

The guidance is intended to assist applicants and reviewers in drafting the warnings and precautions, contraindications and boxed warning sections of labeling for human prescription drug and biological products. The recommendations in the guidance are intended to help ensure that the labeling is clear, useful, informative and, to the extent possible, consistent in content and format.

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U.S. FDA Publishes Guidance on Anti-counterfeiting Physical-Chemical Identifiers

October 14, 2011

A U.S. FDA guidance, titled, Incorporation of Physical-Chemical Identifiers Into Solid Oral Dosage Form Drug Products for Anti-counterfeiting is available.

The guidance provides recommendations on:

  • Design considerations for incorporating physical-chemical identifiers (PCIDs) into solid oral dosage forms (SODFs)
  • Supporting documentation to be submitted in new drug applications or abbreviated new drug applications to address the proposed incorporation of PCIDs in SODFs
  • Supporting documentation to be submitted in post approval submissions to report or request approval to incorporate PCIDs into SODFs
  • Procedures for reporting or requesting approval to incorporate PCIDs into SODFs as a post approval change

    Read more

  • U.S. FDA Draft Guidance Available on Aseptic Preparations for PET Drugs

    October 5, 2011

    A U.S. FDA draft guidance intended to help manufacturers of Positron Emission Tomography (PET) drugs meet the requirements for the Agency’s CGMP regulations for PET drugs is now available.

    Comments on Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography (PET) Drugs should be submitted by December 29.

    Read more

    U.S. FDA Collection of Information on PDMA Available

    October 3, 2011

    A collection of information related to the reporting and record keeping requirements contained in the regulations implementing the Prescription Drug Marketing Act is now available.

    Comments should be submitted by October 31.

    Read more

    U.S. FDA Collecting Information on CGMP Regulations for Finished Pharmaceuticals

    September 28, 2011

    The U.S. FDA is announcing that a collection of information is available on Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals.

    FDA originally ran the collection of information on cGMP Regulations for Finished Pharmaceuticals in the May 31 Federal Register and received one comment from a plasma protein therapies association. The comment stated that data from their association members may be higher than FDA’s estimates of it taking 20 hours per record-keeper to create 25 new SOPs for a total of 50,000 hours and assuming that approximately 100 firms will have to create up to 25 SOPs for a total of 2,500 records.

    FDA has responded that the burden estimates in the 60-day notice were compiled by FDA personnel (including field personnel who visit sites and review records) familiar with the records and the time it takes to assemble and maintain these records. Additionally the Agency has requested that companies who disagree with the burden estimates provide specific proposals on what the burden estimates should be.

    Comment by October 28.

    Read more

    U.S. FDA Guidance Available on User Fee Waivers/Reductions/Refunds for Drug, Biological Products

    September 28, 2011

    The U.S. FDA has announced the availability of a guidance on user fee waivers, reductions, and refunds for drug and biological products.

    This guidance describes the types of waivers and reductions permitted under the user fee provisions of the Food Drug & Cosmetic Act and the procedures for submitting requests for waivers or reductions and requests for reconsideration and appeal. The guidance also provides clarification on related issues such as user fee exemptions for orphan drugs. It also provides recommendations to applicants considering whether to request a waiver or reduction in user fees.

    Read more

    U.S. FDA Public Meeting on PDUFA to be Held in October

    September 12, 2011

    A U.S. FDA public meeting will be held on October 24 from 9 a.m. to 5 p.m. to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA).

    The recommendations include a new review program for new molecular entity NDAs and original BLAs; proposals to enhance regulatory science and expedite drug development; enhanced benefit-risk assessment; modernization of FDA’s drug safety system; requirements for electronic submissions with standardized application data; a technical correction related to discontinued products; and modifications to the PDUFA inflation adjuster with continued evaluation of the workload adjuster.

    Registration to attend the meeting must be received by October 10.

    Read more

    U.S FDA Collection of Information Relating to Disputes During GMP inspections

    September 6, 2011

    The U.S. FDA has published a collection of information notice related to its formal process for dispute resolution when there is disagreement about a scientific or technical issue arising from a GMP inspection.

    The request relates to the number of firms who are likely to use the dispute resolution process annually and the length of time it will take to prepare and submit the required supporting documentation.

    Comments should be submitted by October 6.

    Read more

    U.S. FDA PET Guidance Finalized

    September 1, 2011

    A U.S. FDA guidance on positron emission tomography (PET) drug applications has been finalized.

    The guidance, PET Drug Applications – Content and Format for NDAs and ANDAs, is intended to assist manufacturers of certain PET drugs in submitting new drug applications or abbreviated new drug applications in accordance with the Federal Food, Drug, and Cosmetic Act and FDA regulations.

    Read more

    U.S. FDA Draft Guidance Recommends Evaluation Criteria for Scored Tablets

    August 30, 2011

    A draft FDA guidance, entitled, Tablet Scoring: Nomenclature, Labeling and Data for Evaluation, provides recommendations to sponsors of NDAs and ANDAs regarding what criteria should be met to facilitate the evaluation of marketing applications for tablets that have been scored.

    Specifically, the draft guidance recommends guidelines to follow, data to provide and criteria to meet, and detail in an application to approve a scored tablet and nomenclature and labeling for approved scored tablets.

    Comments are due by November 28.

    Read more

    U.S. FDA Draft Guidance Released on Medical Device Premarket Review Benefit-Risk Determinations

    August 15, 2011

    The U.S. FDA has released a draft guidance on factors to consider when making benefit-risk determinations in medical device premarket review.

    The recommendations in this guidance are intended to provide greater clarity on FDA’s decision making process with regard to benefit-risk determinations in the premarket review of medical devices.

    Comments are due by November 14.

    Read more

    U.S. FDA Revises 2006 Guidance on Bar Code Label Requirements

    August 11, 2011

    The U.S. FDA has published a revised Q&A guidance about bar code label requirements.

    The revised guidance, published in question and answer form, amends a response of a 2006 guidance with the same title. The revised response addresses the ability of vaccine manufacturers to use alternative coding technologies to the linear bar code requirement.

    Read more

    U.S. FDA Reports Progress of Drug Inspection Collaboration

    August 2, 2011

    The U.S. FDA, together with its European and Australian counterparts, released two reports detailing the results of pilot programs focused on increasing international regulatory collaboration among the agencies so that drug quality and safety can be enhanced globally.

    These pilot programs are part of the FDA's global strategy to ensure the safety and quality of imported products. The new strategy builds on efforts that are currently underway at the FDA.

    Read more

    U.S. FDA Draft Report Released Clarifying CDER's Science and Research Needs

    July 26, 2011

    The U.S. FDA has released a draft report identifying the Center for Drug Evaluation and Research's (CDER) science and research needs.

    The report identifies current priorities in regulatory science related to the mission of CDER and will guide strategic planning of internal research efforts.

    Comments are due on the report by September 26.

    Read more

    U.S. FDA Holding "Town Hall" Meeting with the Director of CDRH in California

    July 15, 2011

    The U.S. FDA is holding a public meeting with the Director of the Center for Devices and Radiological Health and other senior Center Management in San Francisco, Calif. on September 22.

    Advance registration is required.

    Read more

    U.S. FDA Releases Draft Guidance on In Vitro Companion Diagnostic Devices

    July 14, 2011

    The U.S. FDA has released a draft guidance intended to assist sponsors planning to develop a therapeutic product that depends on the use of an in vitro companion diagnostic device or an in vitro diagnostic device that is intended for use with a corresponding therapeutic product and included in the instructions for use in the labeling of those products.

    Entitled, In Vitro Companion Diagnostic Devices, the draft guidance describes certain statutory and regulatory approval requirements relevant to therapeutic product labeling that stipulate concomitant use of a companion diagnostic device to ensure safety and effectiveness of the therapeutic product.

    Comments are due to the Agency by September 12.

    Read more

    U.S. FDA Proposes Removal of Sec. 203.50(a) of PDMA

    July 14, 2011

    The U.S. FDA is proposing to remove the section of the Prescription Drug Marketing Act (PDMA) regulations that requires an unauthorized distributor to provide the purchaser with ''a statement identifying each prior sale, purchase, or trade of such drug'' starting with the manufacturer, because a recent district court's decision to issue an injunction against enforcing the rule.

    Unauthorized distributors have long argued that the rule was impossible to meet when purchasing material from authorized distributors, who are not legally bound to provide pedigree information back to the point of manufacture.

    Comments are due to the Agency by September 12.

    Read more

    U.S. FDA Releases Draft Guidance about Rqmts for Premarket In Vitro Diagnostic and Radiology Devices

    July 12, 2011

    A draft guidance describing the U.S. FDA's intent of how they will enforce premarket notification [510(k)] requirements for certain in vitro diagnostic and radiology devices has been released to the public.

    Comments on the draft guidance, entitled, "Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices" are due October 11.

    Read more

    Collection of Information on the Notification and Recordkeeping Requirements of Exports

    July 8, 2011

    The U.S. FDA is allowing the public an opportunity to comment on a proposed collection of information relative to the notification and record keeping requirements of exports.

    The announcement pertains to exporters who have notified the Agency of their intent to export unapproved products that may not be sold in the United States.

    Comments should be provided by August 8.

    Read more

    U.S. FDA Requests Information on Electronic Records and Electronic Signatures

    July 8, 2011

    The U.S. FDA has revised the February 16 Federal Register notice on the electronic records and electronic signatures collection of information by explaining how the estimated recordkeeping burden has been derived and clarifying the recordkeeping requirements.

    In addition to the recordkeeping Requirements, the Agency is asking each respondent to maintain a set of SOPs which could help the company and FDA in the future determine the methodology the company employed in its systems to ensure that the electronic signatures for its employees on documents submitted to the FDA were valid, if needed.

    The new collection of information will be due by August 8.

    Read more

    ICH Q11 Available for Comment in All Three Regions

    July 5, 2011

    The European Medicines Agency, the Japanese Ministry of Health, Labour and Welfare and the U.S. FDA are seeking consultation for ICH Q11, Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological entities).

    The draft guideline describes approaches to developing process and drug substance understanding and also provides guidance on what information should be provided in CTD sections 3.2.S.2.2 – 3.2.S.2.6. It provides further clarification on the principles and concepts described in ICH guidelines on Pharmaceutical Development (Q8), Quality Risk Management (Q9) and Pharmaceutical Quality Systems (Q10) as they pertain to the development and manufacture of drug substance.

    Comments are due by September to ICH@ema.europa.eu

    Read more

    Comment on the U.S. FDA's Recall Regulations

    June 29, 2011

    The U.S. FDA is asking for comments on the Agency's recall regulations (guidelines).

    Section 701 of the Food, Drug and Cosmetic Act and 21 CFR 7part C, outlines the expectations for firms relative to recalls and include development of a recall strategy, provision of ongoing recall communications and recall termination.

    Comments are due August 29.

    Read more

    EMA and U.S. FDA Collaborate Together on Biosimilar Medicines

    June 23, 2011

    The European Medicines Agency and the U.S. FDA have identified biosimilar medicines as an area of common interest and will be working together to increase their degree of interaction and will begin with a kick-off meeting to discuss the group's activities.

    This biosimilar "cluster" is the latest step in the two agencies' ongoing collaboration on regulatory issues under their confidentiality arrangements, which they first signed in 2003. The degree of interaction between the EMA and the FDA has increased significantly since then, to the current stable level of around 55 interactions per month, according to a report issued by the two agencies.

    Read more

    U.S. FDA Releases Two Draft Guidances on its Approaches to Product Classification

    June 21, 2011

    The U.S. FDA has released two related draft guidances on the Agency's current thinking on approaches for classifying products as drugs and devices, certain additional product classification issues and the interpretation of the term "chemical action" under the Food, Drug & Cosmetic Act.

    Comments on the Draft Guidance for Industry and FDA Staff: Classification of Products as Drugs and Devices and Additional Product Classification Issues and Draft Guidance for Industry and FDA Staff: Interpretation of the Term 'Chemical Action' in the Definition of Device Under Section 201(h) of the Federal Food, Drug and Cosmetic Act should be submitted by September 19.

    Read more

    U.S. FDA Proposes Changes to Sterility Test Requirements For Biologics

    June 21, 2011

    The U.S. FDA has proposed changes to the current sterility test requirements for biological products.

    According to the Agency, the proposed changes will provide manufacturers of biological products greater flexibility and encourage use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products.

    Comment by September 19.

    Read more

    U.S. FDA Collects Information on Formal Dispute Resolution Process Guidance

    June 20, 2011

    The U.S. FDA is requesting public comment on the collection of information relating to the process outlined in their Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Good Manufacturing Practice.

    The guidance was initiated in response to industry's request for a formal dispute resolution process to resolve differences related to scientific and technical issues that arise between investigators and pharmaceutical manufacturers during FDA inspections of foreign and domestic manufacturers.

    Under this guidance, firms seeking formal dispute resolution are required to submit documentation supporting a Tier One request for resolution. If a firm is not satisfied with the outcome of the Tier One review, they may enter into a Tier Two review process.

    Comments are due by August 19.

    Read more

    Draft Guidance on FDA's Current Thinking about Nanotechnology Released

    June 14, 2011

    The U.S. FDA has released a draft guidance about FDA's current thinking on whether FDA-regulated products contain nanomaterials or otherwise involve the application of nanotechnology.

    As a first step towards developing FDA's framework for considering whether its regulated products include nanomaterials or nanotechnology, the Agency has developed some points to consider in the draft guidance to be broadly applicable to all FDA-regulated products, with the understanding that additional guidance may be articulated for specific product areas, as appropriate, in the future.

    Comments are due on the draft guidance entitled, Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology by August 15.

    Read more

    U.S. FDA Grants Period of Enforcement Discretion Related to Drug Safety Reporting Reqmts.

    June 7, 2011

    The U.S. FDA has issued a guidance that grants a 6-month period of enforcement discretion relating to the new drug safety reporting requirements that became effective on March 28 until September 28.

    Called, Enforcement of Safety Reporting Requirements for INDs and BA/BE Studies, the guidance extends the deadline set forth in the Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies.

    FDA expects all sponsors and investigators to be in compliance with the new regulations no later than September 28.

    Read more

    Collection of Information Published on Reporting, Recording Keeping Rqmts. of the Prescription Drug Marketing Act

    June 6, 2011

    The U.S. FDA has published a collection of information related to the reporting and record keeping requirements of the Prescription Drug Marketing Act.

    The reporting and recordkeeping requirements are intended to:

    • ban the reimportation of prescription drugs produced in the United States, except when reimported by the manufacturer or under FDA authorization for emergency medical care
    • limit the distribution of drug samples to practitioners licensed or authorized to prescribe such drugs or to pharmacies of hospitals or other health care entities at the request of a licensed or authorized practitioner
    • require licensed or authorized practitioners to request prescription drug samples in writing
    • mandate storage, handling, and recordkeeping requirements for prescription drug samples

    Comments are due by August 5.

    Read more

    Help the U.S. FDA Advance Global Access to Safe and Effective Vaccines

    June 6, 2011

    The U.S. FDA wants companies to advance global access to safe and effective vaccines and other biologicals that meet international standard by establishing strong regulatory systems that will support regulatory science through a funding opportunity announcement (FOA).

    There are three research objectives to the project:

    • Contribute to the knowledge base of the current state of regulatory oversight of influenza and other vaccines and biologicals by supporting analysis, synthesis, and application of assessments of associated regulatory frameworks and processes in select countries/regions.
    • Enable the timely and effective sharing of scientific findings and data, e.g., on safety and effectiveness of adjuvanted influenza and other vaccines and other emerging technologies in support of developing WHO guidance where appropriate, the utility of new technologies for assessment of product safety, among other areas.
    • Support the sharing and application of knowledge, data, and information through active participation in regional and global networks, such as the African Vaccine Regulatory Forum (AVAREF) and the Developing Countries' Vaccine Regulators Network (DCVRN).

    FDA/CBER anticipates providing up to $800,000 (total costs including indirect costs for one award subject to availability of funds) in support of this project in fiscal year 2011. With the possibility of four additional years of support up to $2,000,000 of funding contingent upon successful performance and the availability of funding.

    The application due date is July 8 and the anticipated start date is August 15.

    To obtain detailed requirements of the project, please refer to the full FOA

    Read more

    U.S. FDA's Shares Information on Its Transparency Initiative

    May 26, 2011

    The U.S. FDA has announced, as part of their transparency initiative, that information will be made available to the public on enforcement activities, including inspections and court actions.

    Under this initiative, a web portal has been created providing access to summary data of inspectional observations, as well as a searchable inspections database which includes the names and addresses of inspected facilities, inspection dates, types of products manufactured and final inspection classification.

    By the end of 2011, the Agency will begin to disclose additional information about FDA evaluations of filers, expand disclosure of Untitled Letters, and in appropriate situations, support industry efforts during a food recall to inform consumers of products that are not subject to the recall.

    Access to this information about FDA's enforcement and compliance activities will provide the following to the public and regulated industry:

    • More information about company practices that may jeopardize public health, as well as about companies that have had satisfactory FDA inspections
    • Information about recall and enforcement activities that will help consumers make decisions about products
    • Information about inspection results, which can be expected to create a greater incentive to bring practices into compliance with the law
    • Information about food products that are not subject to a particular recall, which can help reduce consumer confusion

    Read more

    U.S. FDA's Office of Compliance Elevated to "Super Office"

    May 26, 2011

    U.S. FDA's CDER/Office of Compliance will now house subordinate offices within its organizational structure

    In a May 26 all hands memo, Janet Woodcock, MD, Director, CDER, U.S. FDA, announced that the Office of Compliance has been elevated to a "super office," and Deb Autor (currently the Director of the Compliance office ) will serve as the Acting Director to it.

    "Given CDER/OC's expanding role, size, and importance in achieving the Agency's mission of safeguarding the U.S. drug supply, this structural transition makes a great deal of sense. The reorganization will enable Compliance to align its scientific, technical and legal capabilities with closely related program areas, leveraging our resources and maximizing its ability to achieve its public health mission."

    CDER/OC will also now have three office-wide functions established in its Immediate Office, with counterparts in all sub-Offices: risk science, intelligence, and prioritization; policy and communication; and organizational strategy (strategic planning, organizational development, and QMS).

    Woodcock said that there will be four new offices within the super office:

    • Office of Manufacturing & Product Quality
    • Office of Scientific Investigations
    • Office of Unapproved Drugs & Labeling Compliance
    • Office of Drug Security, Integrity & Recalls (ODSIR)

    Three of these new offices are similar to currently existing divisions, while the fourth, the ODSIR, is entirely new. ODSIR will be dedicated to addressing the challenges of globalization and an increasingly complex drug supply chain. ODSIR staff will take the lead in dealing with issues such as supply chain security, counterfeit and diverted drugs, economically motivated adulteration, import operations, and drug recalls.

    The Office of Compliance joins five other "super offices" that currently exist in CDER.

    Discussion on Genotoxic Impurities to Continue at Cincinnati, Ohio ICH Meeting

    May 19, 2011

    At the ICH Regional Public Meeting in Rockville, Md. on May 19, the establishment of the expert working group for Genotoxic Impurities was discussed by ICH M7 topic rapporteur Warren Ku, Head, Integrative Toxicology, Boehringer Ingelheim.

    He said that the M7 expert working group will meet in Cincinnati, Ohio, to continue to finalize key priority topic areas.

    The group has targeted June 2012 for Step 1. When it is finalized, the M7 guideline will describe the evaluation, qualification and control of impurities in medicines during development and after licensing.

    ICH to Finalize Scope of Q3D, Complete Pre-Step 2 Draft Guideline at ICH Meeting

    May 19, 2011

    The ICH Q3D, Impurities: Guideline for Metal Impurities, Expert Work Group will meet at the ICH Meeting in Cincinnati, Ohio to finalize the guideline scope, complete and review all metal safety assessments, and complete a pre-step 2 draft guideline document for broader review.

    PhRMA representative Mark Schweitzer, PhD, Global Director of Analytical R&D, Abbott Laboratories, said at the ICH Regional Public Meeting, hosted by the U.S. FDA in Rockville, Md. on May 19, that the group is targeting November 2011 as the timeline for reaching Step 2.

    ICH Q11 Reaches Step 2

    May 19, 2011

    At the ICH Regional Public Meeting on May 19 in Rockville, Md., the U.S. FDA announced that ICH Q11, Development and Manufacture of Drug Substances, has reached step 2. Q11 covers the development and manufacture of drug substances, small and complex molecules as well as Q8, 9 and 10 principles as they apply to APIs.

    Jon Clark, Associate Director for Program Policy, Office of Pharmaceutical Science, U.S. FDA, said that Q11 would not be discussed at the next ICH meeting in Cincinnati, Ohio, because the Step 2 documents are open to public comment. He anticipated some discussion of the document at the next ICH meeting in November 2011 in Seville, Spain.

    Comments Sought for Biosimilar, Interchangeable Biological Product Application User Fee Program

    May 10, 2011

    The U.S. FDA is requesting comments relating to the development of a user fee program for biosimilar and interchangeable biological product applications submitted under the Public Health Service Act. Specifically, FDA is looking for public input on the identified principles for development of a 351(k) user fee program.

    The Agency plans to review the comments submitted, hold meetings with public stakeholders and hold industry stakeholder meetings to develop proposed recommendations for the user fee program for 351(k) applications for fiscal years 2013 - 2017.

    Comments should be submitted by June 9; those interested in participating in public or industry stakeholder meetings should let the Agency know prior to June 3.

    Read more

    Collection of Information Requested on Medical Devices

    May 6, 2011

    The U.S. FDA is requesting a of information on medical devices in order to facilitate identifying the current location of medical devices and patients possessing those devices (to the extent that patients permit the of identifying information).

    Manufacturers and FDA (where necessary) use the data to: 1. Expedite the recall of distributed medical devices that are dangerous or defective 2. Facilitate the timely notification of patients or licensed practitioners of the risks associated with the medical device

    Respondents for this of information are medical device manufacturers, importers, and distributors of tracked implants or tracked l/s-l/s devices used outside a device user facility. Distributors include multiple and final distributors, including hospitals.

    Send in your comments by June 6.

    Read more

    Guidance Released on Summary Bioequivalence Data for Abbreviated New Drug Applications

    May 6, 2011

    The U.S. FDA has released a guidance on the submission of summary bioequivalence data for abbreviated new drug applications.

    The guidance is intended to assist abbreviated new drug application (ANDA) applicants in complying with the requirements in the final rule on the submission of bioequivalence data that published in the Federal Register in January 2009.

    The final rule requires ANDA applicants to submit data from all bioequivalence studies (BE studies) the applicant conducts on a drug product formulation submitted for approval, including both studies that demonstrate and studies that fail to demonstrate that a generic product meets the current bioequivalence criteria. The guidance provides recommendations to applicants planning to include BE studies for submission in ANDAs and is applicable to BE studies conducted during both preapproval and postapproval periods.

    Read more

    U.S. FDA Public Advisory Committee Meeting to be Held on May 20

    May 4, 2011

    A U.S. FDA public advisory committee meeting that will cover a review of CDER's pharmacovigilance program, the Agency's nanotechnology research program plan and plans for an upcoming science review of CDRH will be held May 20 at FDA's Silver Spring location.

    Read more

    U.S. FDA to Hold Public Workshop on Reprocessing Reusable Medical Devices

    May 2, 2011

    A public workshop on Reprocessing Reusable Medical Devices will be held June 8-9 at the U.S. FDA's White Oak Conference Center.

    The workshop will discuss factors affecting the reprocessing of reusable medical devices and FDA's plans to address the identified issues.

    Factors affecting reprocessing quality, device design as it relates to reprocessing reusable medical devices, reprocessing methodologies, validation methodologies and healthcare facility best practices will be discussed.

    Interested persons must register on-line by June 1.

    Read more

    Draft Guidance on Validation Methods and Labeling for Medical Devices Updates 1996 Guidance

    May 2, 2011

    A U.S. FDA draft guidance on validation methods and labeling for reprocessing re-useable medical devices has been made available.

    An update to the originally published 1996 guidance, the "Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" draft guidance reflects scientific advances in the technology involved with reprocessing more complex reusable medical devices.

    Comments on the draft guidance should be submitted by August 1.

    Read more

    FDA to Hold Public Meeting About Generic Drug User Fee Program

    April 29, 2011

    The U.S. FDA will hold a public meeting on May 10 from 2 p.m. to 3:30 p.m. at FDA's White Oak Campus to provide a public update and to gather additional stakeholder input on the development of a generic drug user fee program.

    A user fee program could provide necessary supplemental funding, in addition to current Congressional appropriations to facilitate the timely review of human generic drug applications by FDA.

    Read more

    U.S. FDA Conducts Periodic Review of Existing Regulations

    April 21, 2011

    The U.S. FDA is conducting a periodic review of existing regulations to determine if they can be made more effective in light of currently public health needs and to take advantage of advances of innovation.

    The goal of the review is to help ensure the Agency's regulatory program is more effective and less burdensome in achieving its regulatory objectives. FDA is requesting comment and support data on any of its existing rules that would be good candidates to be modified, streamlined, expanded or repealed.

    Comments are due by June 27.

    Read more

    U.S. FDA Seeks Information on Adverse Experience Reporting

    April 21, 2011

    The U.S. FDA is collecting information on Adverse Experience Reporting for Licensed Biological Products and General Records.

    The Agency is looking for comments relating to FDA's adverse experience reporting for licensed biological products and general records associated with the manufacture and distribution of biological products.

    The FDA requires that manufacturers of biological products for human use must keep records of each step in the manufacture and distribution of a product including any recalls. These recordkeeping requirements serve preventative and remedial purposes by establishing accountability and traceability in the manufacture and distribution of products. It also enables the FDA to perform meaningful inspections.

    These records must be kept for no less than 5 years after the records of manufacture have been completed or 6 months after the latest expiration date for the individual product, whichever represents a later date.

    Specifically, the Agency is seeking information on:

    • Whether the proposed of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility
    • The accuracy of FDA's estimate of the burden of the proposed of information, including the validity of the methodology and assumptions used
    • Ways to enhance the quality, utility, and clarity of the information to be collected
    • Ways to minimize the burden of the of information on respondents, including through the use of automated techniques when appropriate, and other forms of information technology

    Read more 

    U.S. FDA's 2011-2015 Strategic Priorities Available

    April 20, 2011

    The U.S. FDA has published a strategic priorities document outlining the goals that will guide the Agency through 2015.

    The Strategic Priorities 2011 – 2015: Responding to the Public Health Challenges of the 21st Century, provides a vision of the FDA that includes a modernized field of regulatory science that draws on innovations in science and technology to help ensure the safety and effectiveness of medical products throughout their lifecycles.

    FDA will also look to promote strengthening the safety and integrity of the global supply chain and strengthening compliance and enforcement activities to support public health.

    Read more 

    Agency Postmarketing Guidance Available

    April 1, 2011

    A guidance on Postmarketing Studies and Clinical Trials that focuses on the implementation of section 505(o)(3) of the Federal Food, Drug and Cosmetic Act is now available.

    The guidance, Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food,Drug, and Cosmetic Act, provides information on implementation of the new requirements for certain postmarketing studies and clinical trials for prescription drugs approved under the FD and C Act and biological products approved under the Public Health Service Act. It also provides a description of the types of postmarketing studies and clinical trials that will generally be required under the new legislation.

    Read more

    User Fee Waivers, Reductions and Refunds for Drug and Biological Products Draft Guidance Available

    March 14, 2011

    A revised draft guidance on User Fee Waivers, Reductions and Refunds for Drug and Biological Products is now available.

    The draft guidance provides recommendations for applicants considering whether to request a waiver or reduction in user fees. It is a revision of a July 1993 draft guidance addressing the same topic.

    For consideration as the final guidance is developed, comments on the draft should be submitted by June 12.

    Read more

    FDA, EMA Announce Pilot for Parallel Assessment of QbD applications

    March 16, 2011

    The U.S. Food and Drug Administration and the European Medicines Agency  have launched a new, voluntary pilot program that will allow parallel evaluation of relevant development and manufacturing data components (known as QbD)  of new drug marketing applications that are submitted to both agencies.

    Reviewers from both agencies will separately assess the quality/chemistry, manufacturing and control section of the NDAs submitted to the FDA and marketing authorization applications  submitted to the EMA. However, there will be regular communication and consultation between European regulators and their U.S. colleagues throughout the review process relevant to QbD aspects of the applications.

    This pilot program began out of concern that certain ICH guidelines were being interpreted differently in Europe and the United States.

    Goals of the pilot program include:

    • Helping to ensure consistent implementation of ICH guidelines for manufacturing quality in the application evaluation process
    • Increasing awareness of these regulatory concepts by staff that review marketing applications and inspect manufacturing facilities as part of the approval process
    • Defining the reviewer and inspector interaction for QbD applications
    • Creating a further way for EMA and FDA assessors/reviewers to share full knowledge about these applications
    • Developing and harmonizing regulatory decisions to the greatest extent possible.

    The pilot will end on March 31, 2014.

    Read more

    Draft Guidance Available on Fermentation-Derived Intermediates, Drug Substances and Related Drug Products for Veterinary Medicinal Use

    March 11, 2011

    A draft guidance is now available on Fermentation-Derived Intermediates, Drug Substances and Related Drug Products for Veterinary Medicinal Use.

    The purpose of the draft guidance is to provide recommendations on what documentation to submit to support the Chemistry, Manufacturing, and Controls Information-information for fermentation derived intermediates, drug substances and related drug products for veterinary medicinal use.

    Comments on the draft guidance should be submitted by May 30.

    Read more

    Guidance on Potency Tests for Cellular and Gene Therapy Products Finalized

    February 16, 2011

    A U.S. FDA guidance about potency tests for cellular and gene therapy products has been finalized. The guidance provides manufacturers of cellular and gene therapy products with recommendations for developing tests to measure potency.

    The recommendations are intended to clarify the potency information needed to support an IND or a BLA. Because potency measurements are designed specifically for a particular product, the guidance does not make recommendations regarding specific types of potency assays or propose acceptance criteria for product release.

    Read more

    U.S. FDA of Information Pertaining to Electronic Records and Signatures is Ongoing

    February 16, 2011

    A of information related to electronic records and electronic signatures is now underway.

    The Agency is looking for comment on:

    • Whether the proposed of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility
    • The accuracy of FDA's estimate of the burden of the proposed of information, including the validity of the methodology and assumptions used
    • Ways to enhance the quality, utility, and clarity of the information to be collected
    • Ways to minimize the burden of the of information on respondents, including through the use of automated techniques when appropriate, and other forms of information technology

    Comments should be submitted by April 18.

    Read more

    CDER's Regulatory Project Management Site Tours and Regulatory Interaction Program Ongoing

    February 16, 2011

    A recent Federal Register announcement indicates pharmaceutical companies who are interested in participating in CDER's Regulatory Project Management Site Tours and Regulatory Interaction Program still have time. This program was initiated to give regulatory project managers the opportunity to tour pharmaceutical facilities. The goals are to provide firsthand exposure to the industry's drug development processes and a venue for sharing information about project management procedures (but not drug-specific information) with industry representatives.

    Proposed agendas should be submitted to the CDER office by April 18.

    Read more

    Comment on Clinical Pharmacogenomics Draft Guidance by April 19

    February 14, 2011

    A U.S. FDA draft guidance on clinical pharmacogenomics is now available. The draft is intended to assist the pharmaceutical industry and other investigators engaged in new drug development in evaluating how variations in the human genome could affect the clinical pharmacology properties and clinical responses of drugs.

    Comment should be submitted by April 19.

    Industry Exchange Workshop to Discuss Future of Medical Products

    February 4, 2011

    An industry exchange workshop on The Future of Medical Products Regulations: Ensuring Safety and Integrity in a Global Market will be held June 20 and 21 at the Marriott Dallas/Plano at Legacy Town Center in Plano, Texas. Co-sponsored by the Association of Food and Drug Officials, the Mid-Continental Association of Food and Drug Officials and the FDA Medical Device Industry Coalition, the workshop will include discussions on:

    • Globalization, Imports and Supplier Controls
    • Medical Product Theft and Criminal Investigations
    • Proposed changes to the 510(k) review process
    • Health fraud
    • Streamlining the FDA Enforcement Process
    • The future of medical products regulation
    • Medical Devices in Canada
    • The Freedom of Information Act
    • Medical Product Complaint Investigations
    • Writing Corrective and Preventive Actions procedures and documents to reflect compliance initiatives
    • Top Ten FDA483 objectionable observations

    Read more

    "Town Hall" Meeting to Engage Industry, CDRH About Important Issues

    February 4, 2011

    A "town hall" discussion with the Director of the Center for Devices and Radiological Health and other senior Center management will be held on March 10 at 8am-12a.m. The purpose of the meeting is to engage in a dialogue about issues of importance to CDRH and members of the public. The meeting will be held at the Irving Convention Center in Irving, Texas.

    Read more

    FDA's Draft Guidance on Positron Emission Tomography (PET) Available

    February 3, 2011

    The U.S. FDA's PET Drug Applications – Content and Format for NDAs and ANDAs draft guidance is now available.

    The draft guidance is intended to assist manufacturers of certain positron emission tomography (PET) drugs in submitting new drug applications or abbreviated new drug applications.

    It revises the March 10, 2000 draft guidance entitled, Draft Guidance for Industry on the Content and Format of New Drug Applications and Abbreviated New Drug Applications for Certain Positron Emission Tomography Drug Products.

    Comments on the new draft guidance are due by April 4.

    Read more 

    Agency to Hold Public Meeting to Assist Producers of PET Drugs File NDAs or ANDAs

    February 3, 2011

    The U.S. FDA will be holding a public meeting to assist applicants in preparing NDAs or ANDAs for fludeoxyglucose (FDA) 18 injection, ammonia N 13 injection and sodium fluoride F 18 injection used in positron emission tomography (PET) imaging.

    FDA expects all producers of PET drugs in commercial clinical use to submit applications for marketing approval by December 12, 2011.

    The meeting will be held March 2, 2011 at FDA's White Oak campus in Silver Spring, MD.

    Read more

    Agency Issues Process Validation Guidance

    January 25, 2011

    The U.S. FDA has issued the Process Validation: General Principles and Practices guidance. The guidance replaces the previous guidance on the subject that was published in May 1987.

    The guidance provides information for the pharmaceutical industry on the elements of process validation for the manufacture of human and animal drug and biological products, including active pharmaceutical ingredients .

    Read more

    U.S. FDA's Deputy Commissioner Accepts Job as Maryland's Secretary of Health and Mental Hygiene

    January 4, 2011

    Joshua Sharfstein, MD, Principal Deputy Commissioner for the Food and Drug Administration has been appointed by Gov. Martin O'Malley as the Secretary of Maryland's Department of Health and Mental Hygiene and will start January 12.

    Until a replacement is appointed, Margaret Hamburg, MD, Commissioner of the Food and Drugs for the FDA, has named John Taylor, Counselor to the Commissioner, as the Acting Principal Deputy Commissioner for the next 60 days. During this time, she will consult with senior FDA leaders and review certain functions and positions of key staff.

    Agency Seeks Comments on GLPs

    December 21, 2011

    The U.S. FDA is seeking comments from the public on whether to amend the regulations governing good laboratory practices (GLPs).

    The Agency has decided that to require a GLP quality system for all facilities/laboratories, as well as to more completely address non clinical studies as they are presently conducted, the Agency would need to modify the existing regulations.

    Comments should be submitted by February 22.

    Read more

    Agency Seeking Comments on Information Related to Application to Market a New Drug

    December 17, 2011

    The U.S. FDA is asking for comments about applications submitted to FDA for approval to market a new drug.

    The Agency is asking for comments on these specific topics:

    • Whether the proposed of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility
    • The accuracy of FDA's estimate of the burden of the proposed of information, including the validity of the methodology and assumptions used
    • Ways to enhance the quality, utility, and clarity of the information to be collected
    • Ways to minimize the burden of the of information on respondents, including through the use of automated techniques, when appropriate, and other forms of information technology

    Under section the Federal Food, Drug, and Cosmetic (FD&C) Act, a new drug may not be commercially marketed in the United States, imported or exported from the United States, unless an approval of an application filed with FDA is effective with respect to such a drug.

    Comments are due by February 15.

    Read more

    Europe News

    EC Releases Concept Paper on Importation of Active Substances

    December 7, 2012

    Introducing EU-wide rules for the importation of active substances, the European Commission has released a concept paper for public consultation.

    The paper address three consultation topics:

    • Equivalence assessment of the rule for GMP
    • Equivalence assessment of the regularity of inspections to verify compliance with GMP and the effectiveness of enforcement of GMP
    • Regularity and rapidity of information provided by the third country relating to the non-compliant producers of active substances

    Comments should be submitted by March 23, 2012.

    Read more

    European Commission’s Concept Paper Introduces Obligatory Safety Features on Medicinal Products for Human Use

    November 21, 2011

    The European Commission has posted a concept paper for public consultation on unique identifiers for medicinal products on its website.

    Delegated Act on the Detailed Rules for a Unique Identifier for Medicinal Products for Human Use and Its Verification, also known as Directive 2011/62/EU, introduces obligatory safety features on medicinal products for human use such as a unique identifier to help provide verification of a product’s authenticity.

    The safety features will also help verify via the labeling on the outer packaging of the medicinal product, if the outer packaging has been tampered with.

    Comment by April 27, 2012.

    Read more

    EMA Requests Comments on Similar Biological Medicinal Product Guideline

    November 17, 2011

    The EMA has released a concept paper explaining the need for revision to the similar biological medicinal products guideline. EMA has asked industry to review the Similar Biological Medicinal Product guideline to propose changes where necessary.

    Comments should be submitted by February 29, 2012.

    Read more

    EMA to Revise Annex 16 of the GMP Guide

    November 8, 2011

    The European Medicines Agency announced that it will revise Annex 16 of the GMP guide Certification by a Qualified Person and Batch Release.

    The revision will bring the chapter up-to-date with:

    • New legislation
    • Positive and negative trends seen in the medicines business environment
    • Developments in science and technology

    The revision will harmonize the GMP guidance and interpretation between the Member States. The consultation deadline is January 31, 2012.

    Read more

    U.S. FDA Reports Progress of Drug Inspection Collaboration

    August 2, 2011

    The U.S. FDA, together with its European and Australian counterparts, released two reports detailing the results of pilot programs focused on increasing international regulatory collaboration among the agencies so that drug quality and safety can be enhanced globally.

    These pilot programs are part of the FDA's global strategy to ensure the safety and quality of imported products. The new strategy builds on efforts that are currently underway at the FDA.

    Read more

    Danish Medicines Agency Updates Guidelines to Facilitate Electronic Submissions

    July 29, 2011

    The Danish Medicines Agency has devised new guidelines for marketing authorizations, variations, updates to Mutual Recognition Procedures, renewals, follow-up and referrals to the coordination group.

    The new guidelines are intended to facilitate electronic submission and processing.

    Read more

    Public Consultation Open on EMA's Revised Draft Guideline on GDP of Medicinal Products for Human Use

    July 18, 2011

    The European Medicines Agency has opened public consultation on the revised guideline on good distribution practice of medicinal products for human use.

    The guideline was revised to take into account developments in the storage and distribution of medicinal products in the European Union and to meet new requirements for wholesale distributors and brokers established in the new Directive 2011/62/EU on falsified medicines.

    Comments are due by December 31.

    Read more

    Australian TGA to Regulate Biologicals Separately

    July 14, 2011

    The Therapeutic Goods Administration (TGA) has decided to regulate biologicals separately from other therapeutic goods, such as blood and blood components.

    According to the TGA, this move will

    • ensure the level of regulation applied matches the level of risk posed by specific biologicals by classifying them into four risk-based classes
    • provide a more flexible framework to respond to changes in technology than has been the case under previous arrangements
    • provide regulatory requirements that are unique for biologicals, because the arrangements for medicines or devices may not be appropriate, particularly in exceptional circumstances
    • reduce the ambiguity about what was included or excluded from regulation through the use of consistent terminology
    • increase international harmonization of therapeutic goods regulation

    Read more

    EMA and U.S. FDA Collaborate Together on Biosimilar Medicines

    June 23, 2011

    The European Medicines Agency and the U.S. FDA have identified biosimilar medicines as an area of common interest and will be working together to increase their degree of interaction and will begin with a kick-off meeting to discuss the group's activities.

    This biosimilar "cluster" is the latest step in the two agencies' ongoing collaboration on regulatory issues under their confidentiality arrangements, which they first signed in 2003. The degree of interaction between the EMA and the FDA has increased significantly since then, to the current stable level of around 55 interactions per month, according to a report issued by the two agencies.

    Read more

    ICH Q11 Available for Comment in All Three Regions

    June 16, 2011

    The European Medicines Agency, the Japanese Ministry of Health, Labour and Welfare and the U.S. FDA are seeking consultation for ICH Q11, Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological entities).

    The draft guideline describes approaches to developing process and drug substance understanding and also provides guidance on what information should be provided in CTD sections 3.2.S.2.2 – 3.2.S.2.6. It provides further clarification on the principles and concepts described in ICH guidelines on Pharmaceutical Development (Q8), Quality Risk Management (Q9) and Pharmaceutical Quality Systems (Q10) as they pertain to the development and manufacture of drug substance.

    Comments are due by September to ICH@ema.europa.eu

    Read more

    Annex 14 from the EU GMP Guide Revised Due to Directive 2002/98/EC

    June 2, 2011

    The European Commission has posted a revised version of Annex 14 from the EU GMP guide that will go into effect on November 30 to its website.

    Relating to the manufacture of medicinal products derived from human blood or plasma, Annex 14 has been modified due to Directive 2002/98/EC in order to set standards of quality and safety for the and testing of human blood and blood components for all uses, including the manufacture of medicinal products.

    Read more

    EDQM Revises General Chapter 5.2.8

    June 1, 2011

    The European Directorate for the Quality of Medicines & Healthcare (EDQM) has revised general chapter 5.2.8 on Minimizing the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products

    This third technical revision takes into account the advancement of science in the area of transmissible spongiform encephalopathies, as well as the evolving situation regarding Bovine Spongiform Encephalopathy across the world. For the classification of countries or regions according to their BSE risk, the revised chapter makes reference to the rules laid down by the World Organization for Animal Health, replacing the previous United Kingdom of Great Britain and Northern Ireland classification.

    New criteria for the sourcing and processing of gelatin and bovine blood derivatives used in the manufacture of medicinal products for human or veterinary use have been introduced, as well as a new subsection on Peptones.

    The revised chapter was adopted by the European Pharmacopoeia Commission on May 3. Implementation will go into effect on July 1.

    Read more

    EMA offers Guideline on Biotechnology-Derived Proteins as Active Substances

    May 19, 2011

    A concept paper has been published by the Biologics Working Party (BWP) of the EMA about the need for a guideline on process validation of medicinal products containing biotechnology derived proteins as active substance.

    The working party stated that even though guidelines related to the quality of biotechnological/biological products have been developed at the EU level, and several documents have been harmonized through the ICH process, those documents do not satisfactorily address the specific aspects of validation and evaluation for biotechnology derived products.

    Specifically, the BWP recommends developing a guideline on the guideline should focus on data requirement for process validation/evaluation for submission of a marketing authorization application or variation. It is anticipated that the draft guideline will be released for consultation in the first quarter of 2012, followed by a six month external consultation period prior to finalization of the document.

    Comments are due on the proposal by August 31 to BWPSecretariat@ema.europa.eu

    Read more

    EMA Posts Concept Paper about Revision to Chapter 8 of EC GMP Guide

    May 3, 2011

    The European Medicines Agency has posted a concept paper that would revise chapter 8 of the European Commission guide to Good Manufacturing Practice.

    The changes would introduce risk-based concepts and provide for more effective investigations and CAPA actions.
    The updates, according to the EMA, reflect the need for Quality Risk Management (QRM) Principles during investigations and when making decisions in relation to recalls. It also will update Chapter 8 to clarify when a quality defect/complaint should be reported to the Competent Authority.

    Read more

    FDA, EMA Announce Pilot for Parallel Assessment of QbD applications

    March 16, 2011

    The U.S. Food and Drug Administration and the European Medicines Agency  have launched a new, voluntary pilot program that will allow parallel evaluation of relevant development and manufacturing data components (known as QbD)  of new drug marketing applications that are submitted to both agencies.

    Reviewers from both agencies will separately assess the quality/chemistry, manufacturing and control section of the NDAs submitted to the FDA and marketing authorization applications  submitted to the EMA. However, there will be regular communication and consultation between European regulators and their U.S. colleagues throughout the review process relevant to QbD aspects of the applications.

    This pilot program began out of concern that certain ICH guidelines were being interpreted differently in Europe and the United States.

    Goals of the pilot program include:

    • Helping to ensure consistent implementation of ICH guidelines for manufacturing quality in the application evaluation process
    • Increasing awareness of these regulatory concepts by staff that review marketing applications and inspect manufacturing facilities as part of the approval process
    • Defining the reviewer and inspector interaction for QbD applications
    • Creating a further way for EMA and FDA assessors/reviewers to share full knowledge about these applications
    • Developing and harmonizing regulatory decisions to the greatest extent possible.

    The pilot will end on March 31, 2014.

    Read more

    EMA Help Pharma Comps Standardize Biopharmaceutical Data with Module 2.7.1

    March 10, 2011

    The European Medicines Agency has published  Appendix IV of the Guideline on the Investigation on Bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1): Presentation of Biopharmaceutical and Bioanalytical Data in Module 2.7.1.

    The objective of the CTD Module 2.7.1 is to summarize all relevant information in the marketing authorization applications dossier with regard to biopharmaceutical studies and associated analytical methods.
    The appendix contains a set of forms to assist applicants in their preparation of 2.7.1. It is anticipated that a standardized presentation will facilitate the evaluation process of the guideline.

    The consultation for this guideline will end on May 31.

    Read more

    Changes to Part I, III of EU GMP Guide Posted to EC Website

    March 10, 2011

    On its website, the European Commission has posted the latest revisions of the European Union Guide to Good Manufacturing Practice, Eudralex Vol 4.

    Part I: Basic Requirements for Medicinal Products
    Revised Introduction to the GMP
    Revised Chapter 4, Documentation (effective  June 30)
    Revised Annex 11, Computerized Systems (effective  June 30 2011)

    Part III: GMP Related Documents
    New guidance on the Site Master File
    ICH Q9, Quality Risk Management, has been moved from GMP Annex 20, to Part III
    ICH Q10, Pharmaceutical Quality Systems, has been named as a Note for Guidance

    Read more

    EMA Launches Public Access to EudraGMP Database

    February 14, 2011

    In early February, the European Medicines Agency launched the long awaited "public access" version of its EudraGMP database.

    This version allows public access to authorization and GMP certificates from all countries in the EU plus Iceland, Liechtenstein and Norway. It eliminates the need to submit applications in paper form; and will facilitate sharing inspection outcomes with other authorities.

    The Agency expects around 3,000 new certificates to be imported into EudraGMP every year. The database will grow rapidly following the introduction of inspections in countries outside the EU and new GMP requirements for active substances.

    Read more

    Asia Pacific News

    TGA Seeks Comments on OTC Regulatory Guideline Revisions

    November 29, 2011

    The Australian Therapeutic Goods Administration (TGA) is seeking comments on its proposed revisions to the 2003 Australian regulatory guidelines for over-the-counter medicines (ARGOM).

    Five revised appendices that provide sponsors with greater clarity on the data requirements for submitting effective OTC medicine applications to the TGA have been released.

    At a later date, the TGA will seek comments on the remaining ARGOM chapters which are associated with the process and format of OTC medicine applications, as well as post-market activities.

    Comments on the document should be submitted by February 11, 2012.

    Read more

    Australian's TGA to Release Online Forms for Medical Device Adverse Events

    August 8, 2011

    Australian's Therapeutic Goods Administration (TGA) will be releasing new online reporting forms for medical device adverse events soon.

    The forms will provide a TGA reference number upon submission and support the attachment of electronic documentation.

    Read more

    U.S. FDA Reports Progress of Drug Inspection Collaboration

    August 2, 2011

    The U.S. FDA, together with its European and Australian counterparts, released two reports detailing the results of pilot programs focused on increasing international regulatory collaboration among the agencies so that drug quality and safety can be enhanced globally.

    These pilot programs are part of the FDA's global strategy to ensure the safety and quality of imported products. The new strategy builds on efforts that are currently underway at the FDA.

    Read more

    ICH Q11 Available for Comment in All Three Regions

    June 28, 2011

    The European Medicines Agency, the Japanese Ministry of Health, Labour and Welfare and the U.S. FDA are seeking consultation for ICH Q11, Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological entities).

    The draft guideline describes approaches to developing process and drug substance understanding and also provides guidance on what information should be provided in CTD sections 3.2.S.2.2 – 3.2.S.2.6. It provides further clarification on the principles and concepts described in ICH guidelines on Pharmaceutical Development (Q8), Quality Risk Management (Q9) and Pharmaceutical Quality Systems (Q10) as they pertain to the development and manufacture of drug substance.

    Comments are due by September to ICH@ema.europa.eu

    Read more

    Australia's Therapeutic Goods Administration to Amend Current Guidelines for OTC Medicines

    June 2, 2011

    Australia's Therapeutic Goods Administration (TGA) has begun a project which will review and amend the current Australian Regulatory Guidelines for over-the-counter (OTC) medicines.

    The ARGOM Review Project will bring the 2003 guidelines that are currently used up-to-date to reflect the current TGA regulatory environment and business practices for over-the-counter medicines.

    The ARGOM 2003 is being updated to:

    • Ensure that the guidelines reflect current legislative regulatory requirements
    • Streamline processes where possible
    • Improve the usability and consistency of the information available to stakeholders in relation to the Australian regulatory requirements for OTC medicines
    • Provide increased transparency about decision making processes
    • Clarify post-market monitoring of OTC medicines

    It is anticipated during the ARGOM update process the TGA will initiate additional longer-term projects to consider particular aspects of the current regulatory requirements and business processes related to OTC medicine regulation.

    Read more

    India to Protect Supply Chain by Adding a UID to Products Sold Domestically

    February 28, 2011

    India plans to protect its medicine supply chains from counterfeit and spurious products by adding unique identifier (UID) code to all drugs sold in the domestic market.

    Unveiled by India's Drug Consultative Committee at its last meeting on February 15, this move follows an earlier requirement for all drugs manufactured in  India for export to carry serialized barcodes by July 1.

    Every strip of medicine available in India by the above date will need to have a 2D bar code and a UID. A phone number will be mentioned above the bar code, where the consumer can text message the UID. A message will tell the consumer whether the drug is an original or not.
    The move is expected to meet opposition, however, from small and medium-sized pharmaceutical manufacturers, who are concerned about the extra cost involved in adding barcodes and UIDs to product labelling.

    Read more

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