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

Sept. 6, 2013

FDA Guidance Addresses Unique Facility Identifiers

In September, the U.S. FDA released a draft guidance concerning the unique facility identifier (UFI) system for registering U.S. and international drug establishments. The requirements for a UFI were specified under the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012. The draft guidance addresses current thinking regarding data standards and information management in regards to UFI registration. Currently, the Agency prefers facilities use a DUNS number as a UFI.

Comments are due Nov. 5.

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June 2013

U.S. FDA Adopts ICH ANDA Guidelines

The U.S. FDA has adopted International Conference on Harmonization (ICH) guidelines concerning requirements for ANDA stability testing. The ICH guidelines adopted cover stability testing of new drug substances, photostability testing new drug substances, stability testing for new dosage forms, bracketing and matrixing designs for stability testing of new drug substances, and evaluation of drug safety data.

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June 5, 2013

Form 3486 Addendum Now Available

In June, the U.S. FDA announced the Agency had developed a Web-based addendum to Form 3486 that provides additional information when a BPD report has been reviewed and evaluated by the Agency as a possible recall. The additional information requested includes information that is not contained in Form 3486, such as distribution patterns, methods of consignee notification, consignees of products for further manufacturing, additional product information, updated product dispositions and industry recall contacts.

Comments are due Aug. 12.

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May 28, 2013

U.S. FDA Releases ICH Q4B Guidance

Comments can be submitted at any time for the recent guidance released by the U.S. FDA on Q4B evaluation and ICH harmonization. The Agency worked with ICH on the development of this guidance which contains results of ICH’s Q4B evaluation of bulk density text from U.S., European and Japanese pharmacopoeias. This guidance recognizes interchangeability between these local pharmacopoeias in an effort to avoid redundant testing.

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May 13, 2013

USP Launches Anti-Counterfeiting Initiative

The United States Pharmacopeia announced the launch of its Center for Pharmaceutical Advancement and Training (CePAT) in May. CePAT is located in Accra, Ghana and will play a key role in tackling the issue of drug counterfeiting in sub-Saharan Africa. Counterfeit medications are a significant issue in this region, as shown by 90% of drug samples tested by USP in Sub- Saharan Africa failed API or sterility.

This new center is also part of a larger effort within USP promoting access to good quality medications across the globe.

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April 17, 2013

Guidance on Beta-Lactam Drugs Now Available

On April 17, the U.S. FDA released a guidance concerning implementation of controls for prevention of cross-contamination of pharmaceuticals and APIs with non-penicillin beta-lactams. At this time, CGMPs only require separation measures for penicillin products. Due to potential cross-contamination health risks, FDA would like to expand the framework to include separation measures for all classes of beta-lactam drugs.

Comments can be submitted at any time for this proposed guidance.

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April 8, 2013

New Pilot Program for INDs

The CBER division of the U.S. FDA is inviting IND sponsors to participate in the Center’s eSubmitter Program, which is an automated, computer-based program, as part of a pilot of the system. eSubmitter includes a template geared specifically for IND applications pertaining to antivenom drugs. This pilot is supposed to provide industry and regulatory staff an opportunity to review the new system and ascertain if it facilitates IND submissions.

Companies interested in participating must submit a request by July 8; only nine sponsors will be selected for the pilot program.

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April 3, 2013

U.S. FDA Posts Glass Syringe Guidance

The U.S. FDA’s Office of Combination Products released its draft guidance, Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4, April 3. This draft guidance offers information for sponsors seeking to conform to ISO Standard 11040-4 for glass syringe product submissions. The Agency has stated that demonstrating ISO conformity does not necessarily ensure that the glass syringe can be joined properly to connecting devices.

This guidance identifies additional information that needs to be included in exemptions and applications. Companies involved in developing or marketing injection devices or components are urged to become familiar with the guidance.

Comments are due July 2.

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April 1, 2013

New Scale-Up and Post-Approval Changes Guidance Available

In early April, the U.S. FDA released a draft guidance for industry concerning scale-up and post-approval changes, titled, SUPAC: Manufacturing Equipment Addendum. The Agency has revised the draft manufacturing equipment addenda by removing equipment examples and clarifying referenced processes. This draft supersedes addenda released in 1998 and 1999.

Comments on the draft guidance are due by July 1.

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March 8, 2013

Comment on U.S. FDA's Draft Plan for Benefit-Risk Assessments

A draft five-year plan is now available showing the U.S. FDA's approach to implementing a framework for benefit-risk assessment in the drug review process under PDUFA.

Comments should be submitted by May 7.

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February 26, 2013

Comment on Financial Disclosure Requirements for Clinical Investigators

Submit your comments at any time on the U.S. FDA's recent guidance concerning financial disclosures for clinical investigators.This guidance will help clinical investigators, industry, and U.S. FDA staff in interpreting and complying with regulations on financial disclosure information required by clinical investigators, including the Agency’s FAQs regarding financial disclosure by clinical investigators. Ultimately, this guidance finalizes the draft guidance on the same topic dated May 2011 and replaces the guidance entitled, Guidance for Industry: Financial Disclosure by Clinical Investigators, dated March 2001.

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February 19, 2013

U.S. FDA Seeks NME and BLA Information Collection

The U.S. FDA proposes to collect information from interviews with manufacturers submitting new molecular entity new drug applications (NMEs) and original biologics license applications (BLAs). This proposal is part of the Agency's performance commitments under PDUFA.

Comments should be submitted by April 22.

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February 15, 2013

Comment on Premarket Reviews Draft Guidance

A U.S. FDA draft guidance concerning the establishment of criteria for individuals performing premarket reviews of medical devices is now available.

Comments should be submitted by April 16.

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February 12, 2013

U.S. FDA Seeks Comments on Drug Shortages Strategic Plan

Under the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), the U.S. FDA is required to draft a strategic plan to tackle the issue of drug shortages. The Agency's Drug Shortages Task Force, therefore, seeks public comments on the development of the strategic plan. The strategic plan will focus on both drug and biological product shortages.

Comments should be submitted by March 14.

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February 11, 2013

U.S. FDA Releases Therapeutic Protein Products Draft Guidance

On February 11, the U.S. FDA released a draft guidance for industry addressing immunogenicity assessments for therapeutic protein products. This guidance is intended to assist drug manufacturers in developing risk-based approaches in both the preclinical and clinical phases of the development of therapeutic protein products that evaluate and mitigate immune responses that could adversely affect safety and efficacy.

Adverse events caused by immune responses have caused sponsors to terminate development of therapeutic protein products. The Agency hopes the guidance will spur the development of risk mitigation strategies.

Comments should be submitted by April 12.

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February 4, 2013

U.S. FDA Photosafety Testing Guidance Available

The U.S. FDA has published a draft guidance on photosafety testing with the goal of harmonizing international assessments. In November 2012, the ICH Steering Committee released a draft guidance, S10 Photosafety Evaluation of Pharmaceuticals, for public comment. This guidance provides recommendations on when photosafety testing is needed in the evaluation of pharmaceuticals. The FDA guidance seeks to harmonize U.S. thinking on photosafety with the ICH guidance.

Comments should be submitted by March 21.

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January 31, 2013

U.S. FDA Guidance on MDUFMA Fee Waivers

A U.S. FDA guidance is available concerning criteria for small businesses to receive Medical Device User Fee and Modernization Act (MDUFMA) fee waivers. In an effort to avoid harming small businesses, MDUFMA provides for reduced or waived fees for applicants who qualify as a "small business." There are two levels of fees: a standard fee and a reduced small business fee. A business qualifies for a small business if reported gross receipts or sales are of no more than $100 million on the company's federal income tax return for the most recent tax year.

Comments should be submitted by March 4.

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January 22, 2013

Comments Due on Postapproval Modifications to Combination Products Draft Guidance

In January, the U.S. FDA released a draft guidance, Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA, intended to provide underlying elements for determining which marketing submission should be required for postapproval changes to a combination product approved under one marketing application, such as a biologics license application (BLA), a new drug application (NDA) or a device premarket approval application (PMA). Comments are due by April 22.

Comments should be submitted by April 22.

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January 22, 2013

Final Rule Available on CGMPs for Combination Products

The U.S. FDA published the Agency's final rule on CGMP requirements for combination products in January. This rule is supposed to clarify which CGMP requirements apply for drugs, devices and biological products united to create combination products. It also lays out a streamlined regulatory framework for companies to demonstrate CGMP compliance for "single-entity" and "copackaged" combination products.

The Agency began addressing CGMP requirements for combination products in 2004 with a draft guidance before issuing a proposed rule in 2009. This final rule will be effective July 22.

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January 16, 2013

U.S. FDA Proposal on Electronic Reporting

The U.S. FDA has released a proposal concerning electronic reporting of adverse events. Currently, the Agency has approval to receive three types of adverse event reports electronically using rational questionnaires. The Agency seeks comments on extending approval for the three existing questionnaires as well as comments on a fourth rational questionnaire that has been proposed.

Comments should be submitted by Feb. 15.

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January 3, 2013

Draft Guidance Available on Submissions Using eCTD Specifications

The U.S. FDA has posted a draft guidance concerning regulatory guidelines for the electronic submissions of applications for drug products, including NDAs, ANDAs, BLAs, and INDs. The guidance outlines requirements for electronic submissions in an FDA-approved format. At this time, the Agency can process and review submissions using eCTD specifications.

Comments on the draft guidance are due March 4.

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January 2, 2013

Premarket Approval Applications Acceptance and Filing Reviews Guidance Posted

Superseding the U.S. FDA's May 2003 guidance on premarket approval filing, there is a new guidance available on the acceptance and filing review criteria for premarket approval applications (PMAs). Due to recent changes in the law, including the reauthorized Medical 88 Device User Fee Amendments of 2012 (MDUFA III), acceptance review has taken on a larger role in encouraging quality PMA applications and allowing FDA to allocate resources more adequately on completed applications. The new guidance includes a modified PMA filing checklist.

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Janaury 2, 2013

U.S. FDA Guidance on 510(k) Submission Criteria Now Available

On Jan. 2, the U.S. FDA posted the guidance, Refuse to Accept Policy for 510(k)s. This guidance specifies the criteria and procedures the Agency will use to determine when a 510(k) submission is administratively complete. After the draft of the guidance was posted in Aug. 2012, the Agency received comments concerning checklist questions related to performance data as well as comments on checklists identified as "analysis" or "discussion" as criteria for acceptance and relevant prior submissions. The Agency has addressed these comments in the guidance.

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Janaury 1, 2013

New Guidance on eCopy Medical Device Submissions in Effect

Effective Jan. 1, the U.S. FDA announced that the final guidance concerning the eCopy Program for medical device submissions is available. The eCopy Program is a new electronic review program for medical device submissions intended to expedite the efficiency of the review process. The new guidance contains standards for electronic submissions and identifies submission types that require an eCopy in order for the submission to be processed.

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Europe News

July 31, 2013

EMA Official to Retire After 16 Years

The EMA has announced the retirement of Patrick Le Courtois, Head of Human Medicines Development and Evaluation. Le Courtois first joined EMA in 1997 and had been part of EMA’s senior management team since 2001. He had been in his current position since 2009.

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May 3, 2013

EMA Releases Reorganization Details

EMA announced in early May initial details regarding the Agency’s planned reorganization. These changes are focused on increasing the efficiency of the organization’s committees. Additionally, EMA expanded access to its centralized databases to partners and stakeholders, making the Agency an informational hub.

Changes start to go into effect at the beginning of August 2013. The full reorganization is expected to take approximately 18 months.

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May 2, 2013

EMA Biosimilars Draft Now Available

On May 2, EMA released the Agency’s draft guidance on biosimilars. This draft establishes principles for establishing whether or not a product can be classified as a biosimilar. Additionally, the document lists principles that must be applied to biosimilars as well as outlining the choice of reference product.

Comments should be submitted by Oct. 31.

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April 18, 2013

EMA Upgrades EudraGMP to Include GDPs

On April 18, EMA announced that the Agency had updated the EudraGMP database to include GDP information in addition to GMP information. The new database will now be called EudraGMDP and will be gradually updated by various E.U. regulatory bodies to include information on wholesale distribution authorizations, GMP certificates, statements of GMP non-compliance, and registrations of active substance manufacturers, importers and distributors.

This database is one of the deliverables of the Falsified Medicines Directive and is intended to make supervision of drug manufacturing and distribution stronger due to greater availability of the information for all parties involved in the supply chain.

April 12, 2013

European Commission Publishes Active Substances Q&A

In April, the European Commission published Version 4.1 of its Q&A document concerning importation of active substances into the European Union. Version 4.1 includes two new questions—2A and 10A. Question 2A deals with applicability of the rules to blood plasma while Question 10A deals with applicability of the rules for starting materials undergoing additional purification or chemical synthesis.

Version 4.1 also removes Question 11B, which dealt with atypical active substances, as further discussion on the topic is warranted.

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March 27, 2013

EMA to Begin PSUR Assessment

Beginning April 1, the EMA will conduct single assessments of periodic safety update reports (PSURs) of active substances used in both centrally and nationally authorized medicine products. Until recently, EMA had only assessed PSURs for centrally-authorized products. This new assessment will require the Agency to analyze all reports for medicines containing certain active substances, including for medicines authorized in more than one member state

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February 25, 2013

Adjusted Fees for EMA Applications Effective April 1

The EMA has announced that adjusted fees for applications will come into effect April 1. The European Commission plans to adjust fees due to the Agency according to the 2012 inflation rate and expects fees to increase by 2.6%, although the exact figure is not yet known. Information on the revised fees will be published by EMA at the end of March.

Applications received by March 31 will be charged the current fee while applications received after this date will be charged the adjusted fee.

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February 6, 2013

European Commission Publishes GMP-Related Draft Guidelines

In early February, the European Commission published two GMP-related guidelines: Guidelines On The Formalised Risk Assessment For Ascertaining The Appropriate Good Manufacturing Practice For Excipients Of Medicinal Products For Human Use and Guidelines On The Principles Of Good Distribution Practices For Active Substances For Medicinal Products For Human Use. The first guideline requires companies to use quality risk management principles within ICH Q9 to assess and clarify risks presented by excipients while the second requires distributors of active substances to develop and maintain a quality system that lays out responsibilities, processes, and risk management procedures.

Comments on both draft guidelines are due April 30.

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January 30, 2013

EMA Releases Draft Guidances on Cross- Contamination in Shared Facilities

The EMA recently released a draft guideline on setting exposure limits to use as risk identification for drug manufacturing in shared facilities, approved by the Safety Working Party in December. This draft guidance seeks to set scientifically-based threshold values for individual active substances applied as risk identification. The manufacturing of different pharmaceutical products in shared facilities provides the potential for cross-contamination due to active substance residues remaining on production equipment or other contact surfaces after cleaning. Active substances need to be restricted to a certain level considered safe. The development of a threshold value (a level of permitted daily exposure, or PDE) is key to this risk identification process.

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January 21, 2013

EMA Publishes Guidance on Summaries of Product Characteristics

In late January, EMA published a guidance for pharmaceutical companies detailing how to prepare and review summaries of product characteristics (SmPCs), consisting of presentations listing the information required in each section of the SmPC along with background information. Prepared by EMA's SmPC Advisory Group, the guidance also outlines the European Commission's guideline on SmPCs. The information within SmPCs is a core feature of marketing authorizations for all medicine products in the European Union and is also the basis for preparing package leaflets.

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January 16, 2013

European Commission Submits Active Substances Template

The European Commission has submitted a draft template to be used for the written confirmation of active substances for human medicinal products exported to the European Union. The document introduces E.U.-wide rules concerning the importation of active substances, allowing importation only if the substances are accompanied by written confirmation from the authority of the exporting third country proving that the manufacturing plant where the substance is made adheres to GMP standards equivalent to those in the European Union.

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Asia Pacific News

Aug. 8, 2013

Australian TGA Releases Pharmacovigilance Update

The Australian Therapeutic Goods Administration published its pharmacovigilance update in August. These pharmacovigilance requirements set out requirements for reporting adverse reactions and safety issues for medications regulated by the TGA. The updates in questions concern a new document from the Office of Product Review, details required for nominating a pharmacovigilance contact person and minor changes to the definition of a healthcare professional.

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July 1, 2013

TGA Publishes 3-Year Engagement Strategy

This summer, the Australian Therapeutic Goods Administration announced its international engagement strategy for 2013–2015. This strategy is in response to the increasing globalization of medicines and medicine products. Priorities will include expanding harmonization to improve the efficiency of pre- and postmarket evaluations, developing a joint Australia and New Zealand Therapeutic Products Agency, ensuring integrity of the drug supply chain and facilitating international collaboration with international regulatory bodies.

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June 4, 2013

Australia’s TGA Adopts EU/ICH Guidelines

Effective June 1, the Australian Therapeutic Goods Administration (TGA) has adopted four EU/ICH guidelines. These include EMA’s guidelines on plasma-derived products, active substance master file procedures, and bioanalytical method validation in addition to the ICH Q3 (R5) guideline on residual solvents.

The adoption of these guidelines followed consultations between TGA and members of industry.

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June 3, 2013

China FDA Finalizes Reorganization

The consolidation of the China Food and Drug Administration, formerly the State Food and Drug Administration, has been finalized.

New pharma-related duties of the CFDA will include pharmacopoeia codification, drug manufacturing certification, GMP certification, drug supply certification and GSP certification. Local FDAs will handle reregistration of drugs, changing approval of class III medical device registrations and contract manufacturing applications.

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January 22, 2013

Chinese Regulatory Authorities Seek to Ensure Quality

Earlier this year, the Chinese Ministry of Health released Good Supply Practice for Pharmaceutical Products, a decree adopted in late 2012, and expected to go into effect June 1. The act seeks to ensure the quality of drugs during distribution by focusing on organizational quality in addition to quality systems and quality control.

The information collection associated with the program will consist of

Elaborating on components of the decree, the China FDA (originally SFDA) recently released three guidelines for comment. One guideline concerns computerized systems and another deals with sampling operation of materials and finished products involved in the drug product manufacturing. The other focuses on GMP confirmation and validation.

January 3, 2013

Indian Pharmacopoeia Releases Compliance Guide

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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