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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.

  • NDA Reviewers to Follow QbR Template

    Nov 20, 2014

    The U.S. FDA has updated its Manual of Policies and Procedures to require reviewers to use a Question-based Review (QbR) for NDAs submitted using a QbR format. In addition, reviewers may choose to follow a QbR review template for NDAs not submitted in a QbR format.

    Previously, QbR had been used solely for ANDAs. This format grew out of the FDA’s Pharmaceutical cGMP’s for the 21st Century Initiative.

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  • PIC/S Establishes Inspectors Academy

    Nov 18, 2014

    At the PIC/S Committee meeting in Paris Oct. 20–21, the Committee established the PIC/S Inspectors Academy (PIA). This Academy—a PIC/S initiative—will feature a Web-based educational center with a focus on harmonizing and standardizing GMP training at the international level using an accredited qualification system.

    PIA should be in operation by the third quarter of 2015.

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  • MHRA Releases Revised GMP Deficiencies Report

    Nov 18, 2014

    Britain’s MHRA recently published its inspection trend data from January 2013 to December 2013 in a revised format. The report also includes information about long-term trends in the “top 10 deficiencies” categories.

    Representatives from PDA were also involved in the revision of this report; see page 43 of the November/December 2014 PDA Letter.

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  • EMA Guideline Seeks to Avoid Repetition in Biosimilar Development

    Oct 30, 2014

    EMA has adopted a new guideline on biosimilars. This guideline allows for the possibility for companies to use a comparator authorized outline the European Economic area during clinical investigation. This is expected to facilitate global development of biosimilars as well as avoid repetition in clinical trials.

    The guideline becomes effective April 30.
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  • EMA Releases Guideline on New Flu Vaccine Framework

    Oct 30, 2014

    EMA has released the third module of a new overarching guideline on influenza vaccines. This guideline proposes establishment of a revised regulatory framework to facilitate more efficient assessment of new flu vaccines. It applies only to vaccines which have received ample regulatory experience as well as some new forms.

    Comments are due January 30.
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  • New Guidance Clarifies Adulteration Circumstances

    Oct 27, 2014

    On Oct. 22, the U.S. FDA released a guidance, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection, per Section 707 of the Food and Drug Administration Safety and Innovation Act (FDASIA). This guidance defines the types of actions or inactions that the Agency considers as constituting delaying, denying, or limiting inspection, or refusing to permit an inspection. This draft follows up on the July 2013 draft guidance of the same name; this guidance clarifies FDA expectations regarding the types of circumstances that make a drug adulterated under the Food, Drug and Cosmetics Act.

    PDA commented on the July 2013 guidance.

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  • WHO Releases Draft Process Validation Guidelines

    Oct 17, 2014
    WHO is expected to present its Proposal For Revision Of The 3 Supplementary Guidelines On 4 Good Manufacturing Practices: Validation, 5 Appendix 7: Non-Sterile Process Validation at the WHO Expert Committee on Specifications for Pharmaceutical Preparations meeting in October. These guidelines reflect the draft revision of the EU’s Annex 15 and allow for different approaches to process validation.
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  • Launch Date Announced for Office of Pharmaceutical Quality

    Oct 16, 2014
    The U.S. FDA has announced the launch date of the Office of Pharmaceutical Quality. OPQ is scheduled to launch January 1, 2015 with Janet Woodcock, MD, as the first acting director, supported by Lawrence Yu as Deputy Director.
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  • Organizational Changes Planned at FDA Office of Regulatory Affairs

    Oct 10, 2014
    The U.S. FDA recently announced changes in the organizational structure of the Office of Regulatory Affairs. To ensure better collaboration with Centers as well as efficiency, each Center will have a single senior executive within ORA responsible for each commodity program. ORA will also work with other Centers such as CBER and CDRH on new initiatives in the area of inspections and training.
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  • U.S. FDA Releases 2015 Fiscal Year Regulatory Science Priorities for Generics

    Oct 8, 2014
    On Oct. 3, the U.S. FDA published its 2015 regulatory science priorities pertaining to generic drugs in accordance with GDUFA. These priorities were prepared based on comments received at the May 16 public meeting and through public dockets. These priorities include: postmarket evaluation of generic drugs, equivalence of complex products, equivalence of locally acting products, therapeutic equivalence evaluation and standards, and and computational and analytical tools.
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  • EMA to Release Clinical Reports to General Public

    Oct 8, 2014

    On Oct 2, EMA’s Management Board adopted a new policy to publish clinical reports contained in all applications for centralized marketing authorizations. The Agency hopes this new policy will better allow the general public to understand its decisionmaking as well as avoid duplication of clinical trials, foster innovation and encourage development of new products. Information that may be considered commercially confidential will be redacted.

    The policy will be effective January 1, 2015 and will apply to all authorizations submitted after that date.

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  • U.S. FDA Plans Further Decisionmaking on Biomarkers

    Oct 7, 2014

    Under the Prescription Drug User Fee Act Reauthorization of 2012, the U.S. FDA is mandated to advance the development of use of biomarkers, which are key in the development of “targeted therapies,” also known as “personalized medicines.” As part of this plan, the Agency partnered with the Brookings Institution’s Engelberg Center for Health Care Reform to host a public workshop Sept. 5 on biomarker development.

    During the workshop, the following were topics of discussion: need for clear standards for the evidence supporting biomarker use, infrastructure and policies promoting development of tests to identify patients for clinical trials, new models for clinical trials that accelerate biomarker development, and methods for assessing treatment effects in small populations.

    The information gathered in this workshop will be used to guide the Agency’s decisionmaking with regard to biomarkers.

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  • U.S. FDA Compliance Data Available Through Public Dashboard

    Oct 2, 2014

    As part of the Presidential Memorandum on Regulatory Compliance, issued January 2011, the U.S. FDA has released a new online dashboard that allows the public access information on the Agency’s compliance, inspection and recall activities. Providing data from FY 2008 to FY 2013, the dashboard includes information on inspections, warning letters, seizures and injunctions, and statistics specific to recalls. This data will be updated semiannually.

    Hosted in a cloud environment, the data can be downloaded, manipulated through the selection of filters, rearranged to format datasets and columns, drilled down and exported.

    The 2011 Memorandum requires federal agencies to make compliance information publicly available using an easily accessible, downloadable and searchable online format.

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  • EDQM: Undeclared APIs Now a Major Problem In Europe

    Oct 2, 2014
    Sept. 10–11, the European Directorate for the Quality of Medicines & Healthcare (EDQM) held its second symposium on strategies to combat counterfeit and other illegal medicinal products. The symposium consisted of representatives from forensic and customs laboratories, national food and drug regulatory agencies, enforcement groups and the European Commission. According to participants, undeclared APIs and other active substances in products offered for sale remain a pressing issue within Europe. These products are often purchased from the legal market as well as acquired from uncontrolled sources.
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  • EMA Addresses Adaptive Licensing Pilot Questions

    Sep 19, 2014
    On Sept. 10 the EMA released a document featuring frequently asked questions from companies regarding the Agency’s adaptive licensing pilot project. The document also clarifies terms of engagement and possible outputs for applicants.
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  • U.S. FDA Outlines When it May Refuse an ANDA Due to Lack of Justification of Impurity Limits

    Sep 17, 2014

    On Sept. 17, the U.S. FDA released the draft guidance, ANDA Submissions—Refuse to Receive for Lack of Proper Justification of Impurity Limits. This draft guidance is aimed at applicants submitting abbreviated new drug applications (ANDAs) for approval of drug products with new strengtSh, and highlights specific deficiencies of information that may lead the Agency to refused to receive an ANDA.

    These deficiencies are failing to justify proposed limits for specified identified impurities in drug substances and drug products that are above qualification thresholds, failing to justify proposed limits for specified unidentified impurities that are above identification thresholds, and proposing limits for unspecified impurities (e.g., any unknown impurity) above identification thresholds.

    Comments are due Nov. 17.

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  • U.S. FDA Finalizes Refuse-to-Receive Guidance on Deficient ANDA Submissions

    Sep 17, 2014

    In early September, the U.S. FDA released a guidance finalizing the October 2013 draft guidance, ANDA Submissions—Refuse-to-Receive Standards. This guidance highlights deficiencies in ANDA submission that could cause the Agency to refuse to receive the submission, meaning the ANDA is not considered sufficiently complete by FDA to permit a more substantive review.

    Comments on the guidance can be submitted at any time.

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  • Revision to Part II of GMP Guide on Active Substances as Starting Materials

    Sep 4, 2014
    Effective Sept. 1, the European Commission has published a revised version of Part II of the EU GMP Guide – Basic Requirements for Active Substances used as Starting Materials. This revision is due to changes in various Annexes of the Guide.
     
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  • Chapters in EU GMP Guide Now Finalized

    Sep 4, 2014
    The European Commission has published the final version of the Chapters 3, 5, and 8 of the EU GMP Guide. Chapter 3 covers premises and equipment, Chapter 5 covers production, and Chapter 8 covers complaints, quality defects and product recalls.

    These chapters will be effective March 1, 2015.
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  • U.S. FDA Guidance on Generics-Related Correspondence Available

    Aug 27, 2014
    In late August, the U.S. FDA announced the release of the draft guidance, Controlled Correspondence Related to Generic Drug Development. This document outlines the process for generic drug manufacturers to submit correspondence when the Agency requests information on generic drug development as well as the FDA’s process for communications related to this correspondence. This part of the Generic Drug User Fee Amendments (GDUFA) of 2012 requiring the Agency to meet certain obligations as part of an effort to speed the delivery of safe and effective generic drugs to the public.

    Comments are due Oct. 27.
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  • Europe Seeks to Expand International Collaboration on Generics

    Aug 20, 2014

    The European Union is currently leading the International Generic Drug Regulators Pilot (IGDRP) to share, upon request from generic pharma companies, the assessment reports generated as part of the decentralized procedure with collaborating regulatory authorities outside the European Union. The initial phase of the project will involve collaborating with Australia, Canada, Taiwan and Switzerland.

    The European Union hopes to use this pilot to expand information-sharing so that medicines can be authorized in different countries at approximately the same time.

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  • Australian Authorities Adopt Real-Time Release and Nonsterile Analysis Guidelines

    Aug 14, 2014

    Australia’s Therapeutic Goods Administration (TGA) recently adopted a number of EU/ICH guidelines, including EMA’s guideline on real-time release testing and ICH Q4B annexes on microbiological analysis of nonsterile products.

    These guidelines became effective Aug. 1.

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  • ICH Guideline on DNA Reactive Substances Recommended for Adoption

    Jul 24, 2014
    The final draft of the ICH M7 Guideline on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk is being recommended for adoption by EU, Japanese and U.S. regulatory authorities.
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  • FDA Draft Guidance Covers ANDA Prior Approval Supplements Under GDUFA

    Jul 21, 2014
    On July 11, the U.S. FDA released a draft guidance intended to assist ANDA applicants preparing to submit Prior Approval Supplements (PASs) and PAS amendments. In addition, the draft describes the Agency’s performance metrics goals for PASs and clarifies how FDA will handle a PAS for an ANDA subject to GDUFA performance metric goals.

    Comments due Sept. 9.
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  • Draft Guidance Looks at GDUFA Performance Metrics for ANDAs

    Jul 21, 2014

    On July 11, the U.S. FDA released a draft guidance that explains how GDUFA performance metrics goals will be applied to ANDAs and prior approval supplements.

    Comments due Sept. 9.

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  • African Medicines Regulatory Harmonization Program Designates Regional Centres of Regulatory Excellence

    Jul 21, 2014
    In late June, the African Medicines Regulatory Harmonization Project announced that ten institutions and institution partnerships were designated as Regional Centres of Regulatory Excellence (RCOREs). These centers will participate in the development of a regulatory workforce across Africa through hands-on training within companies or regulatory authorities.
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  • Taiwan FDA Signs Confidentiality Agreement with EDQM

    Jul 21, 2014
    In late May, the Taiwan Food and Drug Administration signed a confidentiality agreement with the European Directorate for the Quality of Medicines and Healthcare (EDQM), the authority behind the European Pharmacopoeia.
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  • U.S FDA Provides Update on Medical Device Technology Innovation Partnership

    Jul 17, 2014
    The U.S. FDA provided an update on July 17 regarding the Medical Device Technology Innovation Partnership. This partnership grew out of a CDRH innovation initiative in 2011 to reduce the cost device development and expedite the regulatory evaluation of devices. To help, the Partnership worked with several universities to develop a curriculum to provide students and industry with information about the regulatory framework for developing devices for the market. This curriculum, referred to as the National Medical Device Curriculum consisting of case studies, is now available.
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  • U.S. FDA Highlights FDASIA Title VII Efforts

    Jul 14, 2014
    Following the two-year anniversary of the signing of the Food and Drug Administration Safety and Innovation Act (FDASIA), the U.S. FDA highlighted its efforts to meet Title VII requirements. Title VII of the law addresses the safety and integrity of drug products and drug product ingredients in the supply chain. The Agency’s efforts to meet Title VII include a proposed and final rule extending its administrative detention authority to include drugs, a draft guidance on actions the FDA considers constitutes delaying, denying or limiting an inspection, a public meeting held July 12, 2013 on Title VII, a draft guidance on the unique facility identifier system, an annual report outlining the number of registered domestic and international establishments, and a proposed rule on administrative destruction of drugs refused importation into the United States.
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  • U.S. FDA Highlights FDASIA Deliverables on 2-Year Anniversary

    Jul 14, 2014
    The U.S. FDA posted highlights of deliverables required under the Food and Drug Administration Safety and Innovation Act (FDASIA) on its blog following the second anniversary of the law’s passing. These highlights include efforts to address drug shortages, promoting innovation, strengthening user fee programs and enhancing patient engagement.
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  • U.S. FDA Seeks Comments on Cooperative Manufacturing Arrangements for Biologics

    Jul 7, 2014

    U.S. FDA has announced an opening for public comment concerning a proposed extension of data gathering for cooperative manufacturing arrangements for biologics.

    Comments are due Sept. 5.

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  • USP <1223> Available for Public Comment

    Jul 7, 2014

    USP’s Expert Microbiology Committee recently published the draft USP 1223, Validation of Alternative Microbiological Methods for comment.

    Comments are due Sept. 30. The draft is available at the Pharmacopeial Forum. This site requires registration but is free to join.

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  • U.S. FDA 4-Year Strategic Plan Addresses IT

    Jul 7, 2014

    The U.S. FDA released its strategic plan for 2014-2018 on July 1. Highlights include expanding data sharing and bioinformatics capabilities along with overall increased investment in IT.

    Comments are due July 31.

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  • API Committee Releases Two New Publications

    Jul 2, 2014
    The Active Pharmaceutical Ingredients Committee (APIC), part of the European Chemical Industry Council, recently released two documents. One, “How to document,” offers instruction on implementing EU draft guidelines from February 2013 on GDPs for APIs and the WHO guideline on GTDP for starting materials. The other publication provides information on how companies can formulate cleaning validation programs.
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  • U.S. FDA Guidance on 503A Enforcement of Compounders

    Jul 2, 2014
    There is a U.S. FDA guidance available announcing the Agency’s plans to enforce provisions of the Food, Drug, and Cosmetic (FD&C) Act for regulation of compounding facilities. The Act was recently amended by the Drug Quality and Security Act. Specifically, the guidance addresses provision 503A which covers compounded drug products.
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  • FDA Releases Interim Guidance on cGMPs for Compounding Facilities

    Jul 2, 2014
    The Agency is seeking input from stakeholders on an interim guidance concerning cGMPs for facilities registering with FDA as compounding outsourcing facilities under the Drug Quality and Security Act. Specifically, FDA intends to focus on how such facilities can meet 21 CFR Parts 210 and 211. In addition, the Agency seeks comments on alternative approaches that would enable an outsourcing facility to have confidence in the quality of incoming components from sources used by multiple outsourcing facilities without each individual outsourcing facility having to conduct periodic laboratory testing to confirm the information in the third-party supplier's certificate of analysis, and alternative approaches minimizing the need for outsourcing facilities to establish an in-house laboratory while providing confidence about the accuracy of testing performed by a third party used by more than one outsourcing facility.

    Comments are due Oct. 31.
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  • Comments Due Oct. 31 for EMA's ATMP Guidance

    Jun 30, 2014
    The EMA has released a guidance on how advanced therapies should be classified, particularly which products can be classified as ATMPs and which cannot. Comments are due Oct. 31.
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  • U.S. FDA GUDID Guidance Available

    Jun 30, 2014
    U.S. FDA guidance on Global Unique Device Identification (GUDID) finalizes all section of the document, Global Unique Device Identification (GUDID): Draft Guidance for Industry, including sections on how device labelers interface with the GUDID, establishment of GUDID accounts and initial submissions.
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  • U.S. FDA Seeks to Reduce Drug Shortage Impact

    Jun 30, 2014
    The U.S. FDA remains committed to reducing the impact of shortages of critical drugs, including encouraging more suppliers, expediting review of new drug applications for products in short supply, and greater communication on impending shortages.
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  • Australia Accepted as EDQM Assessor

    Jun 26, 2014
    In May, EDQM accepted Australia’s Therapeutic Goods Administration (TGA) as an assessor in EDQM’s procedure for the Certification of Suitability to the monographs of the European Pharmacopoeia, also known as CEPs. Assessors with TGA will participate in the scientific assessment of applications submitted to obtain a CEP. This process involves assessing whether or not monographs control for chemical purity, microbiological quality and, if relevant, risk of transmissible spongiform encephalopathy (TSE) transmission.    
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  • MHRA Committee Explores Supply Chain Issues and More

    Jun 26, 2014
    Britian’s MHRA has published meeting minutes for the GMP/GDP Consultative Committee meeting that occurred April 11 in London. Discussion topics included GDP deficiency data, the Compliance Management Project, the new process licensing portal, self-inspection and data integrity, and more.
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  • U.S. FDA Guidances Offer Social Media Recommendations

    Jun 18, 2014

    On June 17, the U.S. FDA released two draft guidances concerning social media communications from companies concerning their drug and medical device products. The first guidance offers the Agency’s recommendations for communicating risk and benefit information for products using character space-limited online platforms such as Twitter. The second guidance offers recommendations for how companies can respond to and correct online third parties communicating inaccurate or misleading information about a product.

    Comments for both guidances are due September 16.

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  • Brazil Explores Easing Device Registration Requirements

    Jun 18, 2014

    ANVISA, the Brazilian regulatory authority has proposed easing registration requirements for Class I and Class II medical devices. One of these proposals involves changing the format of Technical Dossiers to match those in other countries.

    The public consultation period on these proposals ends July 25.

    (Link goes to the ANVISA Portuguese-language page on the proposals.)

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  • Legislation Targeting Compounders in Senate

    Nov 13, 2013

    In early October, the U.S. Congress released a proposed bill, the Drug Quality and Security Act, which includes language tightening U.S. FDA oversight of compounding pharmacies. The bill creates a class of compounders, called “outsourcing facilities,” that would be regulated by the Agency. This classification will be voluntary; if enacted, hospitals and clinics would have the option of choosing to use either the FDA-regulated pharmacy or one that is not.

    The bill also creates a “track and trace” system for following the movement of prescription drugs across the supply chain. This system would require bar codes on packages of drugs shipped.

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  • Secure Supply Chain Pilot Program Open

    Mar 12, 2014

    In late February, the U.S. FDA officially initiated its two-year Secure Supply Chain Pilot Program. The Agency selected 13 companies to participate in this program; these  companies will be allowed to receive expedited entry for importation of up to five selected drug products into the United States. The Agency will use this program to evaluate resource savings efforts that focus less on low-risk drugs coming into the country, and instead emphasize surveillance on importations of high-risk drug products.

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  • EMA Launches Drug Shortages Catalog

    Nov 6, 2013

    As part of a short-term action to address drug shortages in the European Union, EMA launched a public catalog of drug shortages on its website. The Agency announced that any drug that’s in shortage in more than one member state would be listed. The catalog would be similar to the U.S. FDA’s list of drug shortages on its website. The EMA catalog is part of the Agency’s 13-point plan to address drug shortages.

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  • EMA Publishes Process Validation Revision

    Mar 19, 2014

    In late February, the EMA published its revised process validation guideline. This revision emphasizes continuous process verification and incorporates modern GMP aspects into the guideline, including integration of ICH Q8–Q10, process analytical technology (PAT), QbD, real-time release testing, inclusion of the Annexes and harmonization with the U.S. FDA’s process validation guidance. This revised guideline will then come into effect in August.

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  • U.S. FDA Guidance Covers Improving ANDA Submissions

    Jun 12, 2014
    Comments due Aug. 11 on the U.S. FDA draft guidance, ANDA Submissions—Content and Format of Abbreviated New Drug Applications. As part of an effort to increase the number of original ANDAs the Agency can receive while also shortening the review cycles, the FDA seeks to improve the quality of original ANDA.
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  • FDA Issues First Phase of Global Unique Device Identification Database Guidance

    Jun 11, 2014
    To quickly provide industry with information critical to successful use of the Global Unique Device Identification Database (GUDID), the U.S. FDA is issuing the GUDID Guidance in two phases.The first phase includes updates to sections on establishing and using a GUDID account, the unique device identifier, Global Medical Device Nomenclature (GMDN), and electronic records/electronic signatures. Also included in this phase are GUDID attributes mapped to a fictitious medical device label and a glossary.

    To access an overview of the GUDID database, visit http://www.fda.gov/medicaldevices/deviceregulationandguidance/uniquedeviceidentification/globaludidatabasegudid/default.htm.
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  • Indian Pharmacopoeia Releases Compliance Guide

    Jan 3, 2013

    Earlier this year, the Indian Pharmacopoeia Commission (IPC) released a compliance guide with a number of topics, ranging from good laboratory practices to stability testing as well as water quality regulations. This guide is the first of its kind for IPC and was written with both manufacturers and regulators in mind. IPC hopes the manual will ensure that manufacturers are better able to comply with regulatory and testing requirements.

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