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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.

  • U.S. FDA Releases Finalized Biosimilars Guidance Documents

    May 4, 2015
    In late April, the U.S. FDA released finalized three guidance documents concerning biosimilars. One document specifies how sponsors should approach developing evidence demonstrating biosimilarity to the reference product. Another addresses quality considerations as well as CMC information used for a biosimilar application. And the third is a Q&A document looking at implementation of the Biologics Price Competition and Innovation Act of 2009.
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  • 21st Century Cures Draft Legislation Presented

    May 4, 2015
    On April 30, a draft bill of the 21st Century Cures legislation was presented at a hearing in the U.S. House of Representatives. This proposed legislation seeks to streamline the drug approval process. Earlier proposals had sought a more aggressive accelerated approval process for drugs; the current draft document has been scaled-down.

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  • EP Looks at Reverse Osmosis for WFI Monograph

    Apr 29, 2015

    The European Pharmacopoeia posted a proposed draft of a revision to its Water for Injections (WFI) monograph on April 1. This revision takes into account nondistillation methods for producing injection-quality water, namely reverse osmosis combined with deionization and ultrafiltration.

    Comments on the proposed revision are due June 30.

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  • Former FDA Commissioner Now at Institute of Medicine

    Apr 8, 2015

    Former U.S. FDA Commissioner Margaret Hamburg, MD, is now foreign secretary for the Institute of Medicine, an arm of the National Academy of Sciences. She will advise the Institute on international health matters as well as liaise with foreign medicine and health academies. Her term began April 6 and lasts until June 30, 2019.

    Previously, she served as FDA Commissioner from 2009 to March 2015.

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  • Annex 15, "Qualification and Validation," Now Updated

    Apr 8, 2015

    Annex 15, “Qualification and Validation,” of the EU GMP Guide has been updated. The new version will harmonize with the principles of ICH Q8–Q10 as well as the EMA guidance on process validation. These updates include the following: retrospective validation no longer considered acceptable, new points on data integrity, “ongoing process verification” now must be based on equivalent documentation, and more.

    The updated version of Annex 15 becomes effective Oct. 1.

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  • Excipient Guidelines to Become Stricter in 2016

    Apr 6, 2015

    The European Commission announced on March 21, an updated and more detailed version of its Guidelines on Risk Assessment of Excipients. Under these new guidelines, manufacturing authorization holders are required to implement risk assessments of their entire supply chains from raw material sources to packaging.

    The steps taken for maintaining quality of an excipient must be extensively documented with a track-and-trace system fully in place. A quality control expert is now required to assess the excipients and release batches.

    These guidelines become effective March 21, 2016.
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  • European Commission Updates API GDP Guidelines

    Apr 6, 2015

    On March 21, the European Commission announced changes to its Guidelines on GDP for APIs, aimed at API importers and distributors. These changes include: requirements for API distributors to implement a quality system featuring a designated person with risk management responsibility at each point in the distribution chain, a traceable supply chain, suitable cold chain conditions, documented and investigated deviations to established procedures, effective CAPAs in place, one-year record retention policies, and examinations of all API deliveries for damage.

    The new guidelines become effective Sept. 21.
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  • EMA to Revise Some Documentation Requirements for Clinical Trial Materials

    Mar 31, 2015

    Comments due June 30 on EMA’s concept paper on the need to revise requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials.

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  • EMA Network Develops 2020 Strategy

    Mar 31, 2015

    EMA released a consultation paper March 31 outlining a draft network strategy for European Medicines Agencies Network. EMA along with various health authority leaders developed this strategy to focus on expanding collaboration across the European Union on health matters. The strategy’s four themes are: human health, animal health, optimization of the network’s operations, and the global regulatory environment.

    Comments from stakeholders are due June 30.

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  • WHO Releases Report on Substandard, Counterfeit Medicines

    Mar 26, 2015

    WHO released a report on substandard and counterfeit medicinal product March 20 that features recommendations for health authorities to detect and respond to the issues of substandard and counterfeit products, including greater inspections focusing on quality monitoring, laboratory testing throughout the supply chain, implementation of track-and-trace systems, and a system of regional alerts.

    WHO developed this report during an October 2014 Member State Meeting. The next such meeting will be held in the fall of 2015.
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  • EMA Management Board Elects New Vice Chair

    Mar 24, 2015
    The EMA’s Management Board has elected Christa Wirthumer-Hoche as its Vice-Chair. She replaces Walter Schwerdtfeger.

    Wirthumer-Hoche is currently Head of the Austrian Medicines and Medical Devices Agency.
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  • ICH Steering Committee Seeking Additional ICH Q11 Information

    Mar 24, 2015

    ICH seeks input concerning its ICH Q11 Q&A document for potential issues that should be included.

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  • Proposed Bill to Require Shorter time for FDA to Review Products Approved in Europe

    Mar 24, 2015
    A bill was recently introduced in Congress that, if passed, would require the U.S. FDA to review drug products approved by EU authorities within 90 days. This bill, the Speeding Access to Already Approved Pharmaceuticals Act, seeks to address the lag between approval of a drug product in Europe and in the United States. Currently, the shortest time between approval is six months.
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  • New Vice Chair for MHRA Commission Named

    Mar 11, 2015

    Angela Thomas is now the vice chair of MHRA’s Commission on Human Medicines. She replaces Ian Weller.

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  • USP Elemental Impurities Chapters to Align with ICH Q3D

    Mar 11, 2015
    USP announced that the chapters pertaining to elemental impurities, <232> Elemental Impurities—Limits and <2232> Elemental Contaminants in Dietary Supplements, will be applicable Jan. 1, 2018 in order to align <232> with implementation of ICH Q3D.
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  • TGA Releases Two-Part Batch Release Guidance

    Mar 11, 2015
    Australia’s TGA recently released a guidance on batch release containing two parts. The first offers guidance on general requirements and the other provides examples of how these general requirements can be met. This latter part is currently being developed.
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  • Public Docket Established for Compounding Regulations

    Mar 11, 2015
    The U.S. FDA has established a public docket to receive comments on matters concerning pharmacy compounding regulations. This docket is intended for general comments and not directed at a specific document or issue.

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  • FDA Approves First U.S. Biosimilar

    Mar 11, 2015
    The U.S. FDA approved the first U.S. biosimilar, filgrastim-sndz (ZARXIO Injection, Sandoz Inc.). This is a biosimilar for Neupogen, a treatment for lack of white blood cells due to certain cancers.
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  • U.S. FDA, WHO Recommend New Strains for 2015-2016 Flu Vaccine

    Mar 6, 2015

    Following recommendations from the WHO, the U.S. FDA in early March recommended that the influenza vaccine for the 2015-2016 season include the following strains:  A/California/7/2009, A/Switzerland/9715293/2013, and B/Phuket/3073/2013. This follows a particularly deadly 2014-2015 flu season where the vaccine proved to be only 23% effective.

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  • Health Canada Ramps Up Inspections

    Mar 6, 2015

    In late February, Health Canada announced plans to ramp up announced and unannounced inspections of manufacturing facilities due to increasing API concerns and data integrity issues.

    The Agency has also posted an online Inspection Tracker for drug manufacturing facilities that provides a snapshot of the health and safety issues the Agency is tracking on a regular basis.

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  • United States Seeks to Strengthen Device Postmarket Surveillance

    Feb 26, 2015

    The U.S. FDA released a report with the Brookings Institution in late February outlining recommended steps to develop a National Medical Device Postmarket Surveillance System. This report offers a strategy for developing a nationwide system that harnesses data, analysis and stakeholder participation to optimize surveillance in an effort to achieve optimal patient care.

    This report has its origins in CDRH’s 2012 initiative to strengthen the U.S. surveillance system for devices. This initiative also includes efforts to implement unique device identifiers for devices.
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  • FDA Looking at cGMP Recordkeeping

    Feb 25, 2015

    The U.S. FDA released a request for information concerning the recordkeeping of cGMP requirements for finished pharmaceuticals.

    Comments are due March 27.

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  • U.S. FDA Provides More Info for Compounders

    Feb 25, 2015

    In February, the U.S. FDA released five draft documents concerning drug compounding and repackaging in an effort to ensure relevant entities comply with key public health regulations. These documents follow the enactment of the Drug Quality and Security Act (DQSA) in November 2013. Products compounded in outsourced facilities under certain conditions may be exempt from provision of the Food, Drug, and Cosmetic Act.  

    One document details the regulatory impact of registering as an outsourcer. Another document explains how FDA will respond to repackaging violations by entities falling under the DQSA. A third document describes conditions under which the Agency will not take action for certain regulatory violations that occur due outsourcing facilities mixing, diluting and repackaging biologics. A fourth explains adverse reporting steps for recognized outsourcing facilities. And a fifth, a draft Memorandum of Understanding, outlines a state’s responsibilities when signing the MOU to investigate complaints regarding compounded drug product.

    Comments on all of these documents, except the MOU are due May 20. MOU comments are due June 19.

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  • FDA Commissioner to Step Down

    Feb 6, 2015
    This week U.S. FDA Commissioner Margaret Hamburg, MD, announced plans to step down from her position at the end of March. Acting Chief Scientist Stephen Ostroff, MD, has agreed to serve as Acting Commissioner when Hamburg leaves.
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  • EMA GMP Guide Revisions Account for Cross-Contamination and Toxicological Assessments

    Feb 5, 2015

    Chapters 3 and 5 of the GMP Guide covering premises and equipment and production respectively have been updated to account for improvements to the guidance on cross-contamination and references to toxicological assessment.

    These updates become effective March 1 in an effort to align with the EMA guideline Setting Health Based Exposure limits for Use in Risk Identification in the Manufacture of Different Medicinal Products in Shared Facilities.

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  • EMA Releases Annex 1 Revision Concept Paper for Comment

    Feb 6, 2015

    EMA’s concept paper covering the revision of Annex 1’s GMP guidelines for manufacturing sterile product has been released for comment. This follows agreement on the document in January between EMA’s GMP/GDP Inspectors Working Group and PIC/S.

    Comments are due March 31.
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  • WHO Seeks Worldwide Pharmacopeial Harmonization

    Feb 5, 2015

    On Jan. 15, WHO released a draft document covering Good Pharmacopoeial Practices. This document seeks to ensure harmonization of global pharmacopeial practices.  

    Comments are due March 10.

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  • Congressional Hearing to Look at Modernizing Flu Vaccine Production

    Feb 3, 2015

    On Feb. 3, the U.S. Congress’ Committee on Energy and Congress will hold a hearing to explore public health responses to seasonal influenza. The hearing will look at modernization of current standards for selecting strains of influenza virus for vaccines as well as improving the production process for flu vaccines.

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  • India Plans to Formalize Presubmission Meetings

    Feb 2, 2015

    India’s Central Drugs Standard Control Organization (CDSCO) laid out plans to formalize presubmission meetings in a Jan. 28 notice. Presubmission meetings allow companies and regulators an opportunity to review potential submissions and ensure they conform to regulatory requirements. By formalizing these meetings, CDSCO is aligning itself with practices of other global regulators.

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  • Proposed U.S. Legislation Seeks More Efficient FDA Reviews

    Jan 30, 2015
    Recently released draft legislation from the U.S. Congress’ House Energy and Commerce Committee includes provisions focusing on expediting U.S. FDA regulatory review of new and existing drug and device products. This legislation, the 21st Century Cures Initiative, seeks to improve the efficiency of the development process for innovative medical products.
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  • Revised CFDA GMPs Emphasize Quality Management Systems

    Jan 29, 2015

    China’s Food and Drug Administration recently revised its GMPs for medical devices, updating the regulations to require manufacturers to setup quality management systems adhering to the GMPs.

    These revised GMPs become effective March 1.

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  • Chinese FDA Releases First GSPs for Devices

    Jan 29, 2015

    The Chinese Food and Drug Administration recently issued the country’s first GSP regulations for all Class 1, 2, and 3 medical device distributors. Third-party logistics providers also fall under these new regulations, which establish minimum standards for procurement, storage, transportation and postsale services and require distributors to implement quality management systems for all aspects of the delivery process.

    These new GSPs became effective Dec. 12.
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  • Britain’s MHRA Releases Data Integrity Guidance

    Jan 27, 2015

    On Jan. 23, Britain’s MHRA released a guidance outlining the authority’s expectations for data integrity within the industry. The document also lists MHRA’s definitions for data integrity-related terms.

    The guidance is intended complement existing EU GMP regulations.
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  • U.S. FDA Releases Guidance on cGMPs for Combo Products

    Jan 27, 2015

    On Jan. 27, the U.S. FDA released a draft guidance on cGMPs for combination products that further clarifies the final rule on these types of products. The guidance looks at general considerations for cGMP requirements for combination products, addressing the purpose and content of specific cGMP provisions within the final rule. Additionally, the guidance includes hypothetical scenarios clarifying how to comply with specific cGMP requirements.

    Comments are due March 30.
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  • EMA Seeks Expanded Global Generics Access

    Jan 22, 2015
    As part of the International Generic Drug Regulators Pilot (IGDRP), EMA will share its assessments of generic medicine applications with collaborating regulatory authorities outside the European Union as part of an effort to facilitate efficient access to affordable generics across the globe.
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  • U.S. FDA, Global Regulators Piloting Device Single Audit Program

    Jan 22, 2015
    Global manufacturers interested in marketing medical devices in Australia, Brazil, Canada and the United States have been invited to participate in the Medical Device Single Audit Program, a pilot program sponsored by the U.S. FDA and regulatory agencies in Australia, Brazil, Canada, and Japan.
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  • ICH Q3D Elemental Impurities Guideline Finalized

    Jan 15, 2015
    In December the ICH Q3D Guideline on Elemental Impurities reached Step 4 of the ICH process. Now the guidance has entered the implementation period, or Step 5. The ICH Q3D Guideline provides global policy for limiting metal impurities in drug products and ingredients.
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  • FDA Officially Launches Office of Pharmaceutical Quality

    Jan 14, 2015

    The U.S. FDA officially launched its new Office of Pharmaceutical Quality on January 12. The new office creates a streamlined drug quality program responsible for drug application review, postapproval improvements, and inspections and surveillance of manufacturing facilities.

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  • EMA Approves First Stem Cell Therapy Product in Europe

    Jan 6, 2015

    EMA approved Holoclar in December for use in the European Union. This is the first advanced therapy medicinal product (ATMP) using stem cells that has been approved in Europe. Holoclar treats limbal stem cell deficiency, a rare eye condition that can cause blindness.

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  • FDA Publishes Conclusions of QbD Parallel Assessment with EMA

    Jan 6, 2015

    In late December, the U.S. FDA started publishing joint Q&A documents with EMA outlining conclusions of the agencies’ first parallel assessment of QbD elements of a marketing authorization application. Both FDA and EMA found the assessment useful, reaching agreement on many QbD aspects. Experts from the Japanese Pharmaceuticals Medical Devices Agency also participated as observers for this assessment.

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  • FDA Releases Final Guidance on Electronic Submissions

    Dec 18, 2014

    Along with the final guidance for electronic submissions of standardized study data, on Dec. 18, the U.S. FDA released the final version of the guidance Providing Regulatory Submissions in Electronic Format—Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act, which describes how the Agency will implement electronic submission requirements under the Food and Drug Administration Safety and Innovation Act (FDASIA).

    Comments may be submitted at any time on this document.

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  • Electronic Submission Requirements for Standardized Study Data Finalized

    Dec 18, 2014

    On Dec. 18, the U.S. FDA released the final version of the guidance Providing Regulatory Submissions in Electronic Format—Standardized Study Data. This guidance covers how the Agency will implement electronic submission requirements for standardized study data contained in NDAs, BLAs, INDs and ANDAs.

    Comments may be submitted at any time on this document.

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  • New European Regulation Covers API GMPs

    Dec 17, 2014

    In November, the European Commission published a new regulation covering GMPs for APIs. This regulation outlines principles and guidelines for active substance GMPs. This includes exported active substances.

    The regulation became effective Dec. 15.

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  • ICH Meeting in Lisbon Looks at GMP Quality Updates

    Dec 17, 2014

    In Q4, the ICH Steering Committee along with its Expert Working Groups met in Lisbon. Among the topics under discussion were GMP-related Quality Updates. These included agreeing upon the final set of Q7 Q&As on APIs, convening the new Expert Working Group on Technical and Regulatory Considerations for Pharmaceutical Lifecycle Management (Q12), and approving a concept paper and business plan for developing Q11 Q&As to clarify selection of starting materials and information that needs to be provided for marketing authorization applications.

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  • Guideline Takes Risk-based Approach to Contamination in Shared Facilities

    Dec 11, 2014

    EMA recently published the final version of its Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities. This document takes a risk-based approach to the management of contaminants in shared facilities.

    The guideline comes into effect June 1.
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  • U.S. FDA Releases UDI Roadmap with Brookings

    Dec 10, 2014
    On Dec. 5, the U.S. FDA released a “roadmap,” a report commissioned from the Brookings Institution, for how provider systems, patients, payers, supply chain personnel, and many others, can adopt and utilize unique device identifiers. The Agency hopes these recommendations ensure that the UDI system not only runs efficiently but serves as a tool for unlocking important data to help patients.
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  • U.S. FDA Releases SUPAC Equipment Guidance

    Dec 4, 2014

    The U.S. FDA is concerned that equipment addenda published in 1998 and 1999 on scale-up post-approval changes (SUPAC), may not reflect current practices and possibly limit manufacturers from continually evaluating and updating practices. For this reason, on Dec. 2 the Agency released the guidance SUPAC: Manufacturing Equipment Addendum.

    Comments on the guidance may be submitted at any time.

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  • EMA and FDA Confer in London on Mutual GMP Inspections

    Dec 1, 2014

    Representatives from the U.S. FDA met with a cross-agency team comprised of members from EMA, the European Commission and GMP experts from various EU member states in London Nov. 14 and 17 to discuss progress on mutual reliance between FDA and the European Union on GMP inspections.

    Although there has been an ongoing initiative around GMP inspections and mutual recognition for many years, due to increased momentum, this meeting is supposed to be the first face-to-face meeting of both teams.

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  • Australia and New Zealand Agree to Shut Down Joint Regulatory Body

    Dec 1, 2014

    The Australian and New Zealand governments confirmed in late November that both governments will cease efforts to establish the joint therapeutic products regulatory body, or Australia New Zealand Therapeutic Products Agency (ANZTPA), following an assessment of the costs and benefits for both countries.

    Australia’s Therapeutic Goods Administration (TGA) and New Zealand’s Medicines and Medical Devices Safety Authority (Medsafe), however, plan to continue exploring other harmonization activities between both regulatory authorities, including the development of a new agreement on information sharing as well as a formalized mutual recognition of GMP audits.

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  • Final Concept Paper on ICH Q12 Endorsed

    Nov 24, 2014

    The ICH Steering Committee recently endorsed the final concept paper Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. This new document offers guidance on building a framework to facilitate efficient management of postapproval CMC changes.

    ICH Q12 is a continuation of the Q8–Q11 guidelines and seeks to promote innovation, continual improvement while also strengthening QA and reliable supplies of the product.

    ICH plans adoption of a Step 2 document in 2016.

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