Skip To The Main Content

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.

  • Sci Tech Council Urges New Tech for Pharma, Biopharma

    Jul 7, 2016

    In April, the Subcommittee for Advanced Manufacturing of the National Science and Technology Council, a Cabinet-level council in the U.S. executive branch, published a report that captured technology areas in advanced manufacturing that are current priorities for the U.S federal government and are strong candidates for focused Federal investment and public-private collaboration. Emerging technology areas include advanced materials manufacturing, engineering biology to advance biomanufacturing, biomanufacturing for regenerative medicine, advanced bioproducts manufacturing and continuous manufacturing of pharmaceuticals.

    Continue reading »
  • EMA Releases Annual Report for 2015

    Jul 7, 2016

    The European Medicines Agency’s (EMA) 2015 annual report, published May 17, 2016, focuses on the Agency’s core tasks, including evaluation of medicines, support of research and development of new and innovative treatments and the monitoring of benefits and risks of medicines in practice. The Annual Report also highlights some of the main projects, initiatives and achievements from 2015 that have had a significant impact on EMA and its operations.

    Continue reading »
  • FDA Releases 3D Printing Guidance

    Jul 7, 2016

    The U.S. FDA draft guidance, Technical Considerations for Additive Manufactured Devices, outlines the Agency’s initial thinking on technical considerations specific to medical devices using additive manufacturing (AM), the broad category of manufacturing encompassing 3-dimensional (3D) printing. The draft guidance outlines technical considerations associated with AM processes and recommendations for testing and characterization for devices that include at least one AM fabrication step. This draft guidance is a “leap-frog guidance,” intended to serve as a mechanism by which the Agency can share initial thoughts regarding emerging technologies that are likely to be of public health importance early in product development.

    Comments on this document should be submitted by Aug. 8.

    Continue reading »
  • FDA Remains Committed to EvGen

    Jul 7, 2016

    The U.S. FDA continues to develop EvGen, its national system for evidence generation. In practice, EvGen would be an umbrella for all activities that help inform all stakeholders about making treatment decisions. The platform is built on the concepts of interoperability and connectivity—essential prerequisites for the creation of a successful national system for evidence generation.

    Continue reading »
  • CDER Launches New Online Export Tracking System

    Jul 7, 2016

    In Q2, CDER launched its new electronic CDER Export Certification and Tracking System. The system allows users to request a CDER Certificate of a Pharmaceutical Product (CPP) online as an alternative to a paper submission. The new software provides many features; including reducing the amount of time it takes to process a certificate, a step-by-step guide to applying for a CPP, real-time validation of data submitted and email notifications regarding the status of a CPP request.

    Continue reading »
  • New Prep and Potency Limits for for Biologics Sought

    May 12, 2016

    The U.S. FDA proposes to amend standards for biologics that pertain to preparations and limits to potency due to the availability of new technology and testing capabilities.

    Comments on this proposed rule are due July 18.

    Continue reading »
  • FDA Releases 3D Printing Guidance for Device Manufacturers

    May 12, 2016

    The U.S. FDA recently released a draft guidance outlining technical considerations for device manufacturers using 3D printing.

    Comments are due Aug. 8.

    Continue reading »
  • EMA Looks at Environmental Risks

    May 12, 2016

    EMA released concept paper on April 28 outlining how to assess the potential environmental risks of medicinal products. The paper includes considerations for risk mitigation strategies for reducing the impact of drug products on the environment.

    Comments are due Oct. 31.

    Continue reading »
  • FDA Makes Recommendations on Immune Assays for Clinical Trials

    May 12, 2016

    The U.S. FDA has released the draft guidance, Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products. This draft guidance provides recommendations regarding development and validation of immune assays for assessment of the immunogenicity of therapeutic protein products during clinical trials.

    Comments are due June 24.

    Continue reading »
  • CDER Launches Export Tracking System

    May 12, 2016

    CDER launched its new electronic CDER Export Certification and Tracking System. The system allows users to request a CDER Certificate of a Pharmaceutical Product (CPP) online as an alternative to a paper submission. The new software provides many features; including reducing the amount of time it takes to process a certificate, a step-by-step guide to applying for a CPP, real-time validation of data submitted and email notifications regarding the status of a CPP request.

    Continue reading »
  • FDA Continues to Look at Compounding

    May 12, 2016

    The U.S. FDA continues to respond to concerns about pharmaceutical compounding with the release of three additional guidances on April 15. These guidances cover prescription requirements, regulation of compounding in state-licensed hospital or health system pharmacies and facility definitions.

    Comments on all three are due by July 18.

    Continue reading »
  • U.S. FDA, Provincial Chinese FDAs Strengthen Cooperation

    May 5, 2016

    Staff from the FDA’s China Office recently met with provincial FDA regulators, industry and academia in China’s Yangtze River Delta region to discuss strengthening partnerships, sharing information and building the foundation for future cooperative engagement.

    Continue reading »
  • FDA Releases Data Integrity Guidance

    May 5, 2016

    The U.S. FDA recently released a long-awaited draft guidance on data integrity and compliance with cGMPs. This document clarifies the role of data integrity in cGMPs.

    Comments are due June 14.

    Continue reading »
  • EMA Releases Sterilization Draft Guideline

    May 5, 2016

    EMA has released a draft guideline on the sterilization of medicinal products, active substances, excipients and primary containers. This draft guideline describes expected documentation for sterile products in the quality dossier for a marketing authorization application or a variation application for a medicinal product.

    Comments are due Oct. 13.

    Continue reading »
  • Second U.S. Biosimilar Approved

    May 5, 2016

    On Apr. 5, the U.S. FDA approved a second biosimilar product, Inflectra (infliximab-dyyb), which is administered by intravenous infusion to treat Crohn’s disease, ulcerative colitis and moderate to severe rheumatoid arthritis. Inflectra is biosimilar to Janssen Biotech, Inc.’s Remicade (infliximab).

    Continue reading »
  • EU/Chinese Work Groups Meet on Anticounterfeiting

    May 5, 2016

    The European Union and China Working Group on Pharmaceuticals recently met to discuss drug evaluation and approval procedure reform, anticounterfeiting legislation and management of online pharmacies. This comes as part of the Consultation and Cooperation Mechanism agreement signed in 2013, which states the China Food and Drug Administration and the European Commission will meet more regularly for constructive dialogue on pharmaceutical laws and regulations.

    Continue reading »
  • FDA Establishes Combo Product Policy Council

    May 5, 2016

    The U.S. FDA recently established the Agency’s first Combination Products Policy Council. This Council will serve as communications hub for discussing, resolving and implementing product and policy issues related to combination products. In addition, the Council will play an integral role in the development of internal and external communications such as draft guidances, publications and blog posts regarding policy decisions.

    Continue reading »
  • FDA to Develop Device Evaluation System

    May 5, 2016

    The U.S. FDA is building the foundations of a national medical device evaluation system to generate better evidence more efficiently for medical device evaluation and regulatory decision making. The collaborative national evaluation system, one of CDHR’s 2016–2017 strategic priorities, will link and synthesize data from different sources across the medical device landscape and improve the quality of real-world evidence that healthcare providers and patients can use to make better informed treatment decisions.

    Continue reading »
  • FDA Approves Change to Continuous Manufacturing

    Apr 14, 2016

    On April 8, for the first time, the U.S. FDA approved a manufacturer’s change from batch to continuous manufacturing. This was for Janssen Product’s HIV-1 medication, Prezista. The company relied on a recently released FDA draft guidance to support the change.

    Continue reading »
  • EMA Elects New Chair for Management Board

    Apr 5, 2016

    On Mar. 17, Christa Wirthumer-Hoche was elected as chair of the European Medicines Agency’s Management Board for a three-year term. The Management Board sets the Agency’s budget, approves the annual work program and is responsible for ensuring that the Agency works effectively and cooperates successfully with partner organizations across the EU and beyond.

    Continue reading »
  • FDA Looks to Lean Management for Combo Products

    Apr 1, 2016

    In order to improve the overall efficiency, consistency and predictability of combination product review, the U.S. FDA is developing a lean management process mapping approach, which includes an analysis of current processes to highlight existing sources of delay or redundancy, and creation of a “future state” map that identifies a streamlined process that addresses the previously identified delays and redundancies.

    Continue reading »
  • EMA Launches PRIME

    Mar 31, 2016

    EMA recently launched PRIME—PRIority MEdicines—its new scheme to strengthen support for the development of medicines that target an unmet medical need. PRIME is based on enhanced interaction and early dialogue with developers of promising medicines to optimize development plans and speed up evaluations so that these medicines can reach patients earlier.

    Continue reading »
  • EP to Accept Nondistilled WFI

    Mar 23, 2016

    The European Pharmacopoeia has revised its monograph on water for injection (WFI) to accept WFI that undergoes a purification process equivalent to distillation, such as reverse osmosis. This revision becomes effective April 2017.

    Continue reading »
  • ORA Ombudsman Takes Office

    Mar 10, 2016

    Jessica Zeller is the new ombudsman in the U.S. FDA’s Office of Regulatory Affairs. Her responsibility is to resolve, when possible, problems between the Agency and external partners.

    Continue reading »
  • CDRH Lists 2016 Guidance Documents

    Mar 10, 2016

    CDRH has released its list of guidance documents for 2016. The documents listed fall under three categories: "A-list" documents the Center fully intends to publish, "B-list" documents to be published as resources permit, and final guidance documents issued in 2006, 1996, 1986 and 1976 subject to retrospective review.

    Continue reading »
  • Chinese Pharmacopoeia Now in Effect

    Mar 10, 2016

    Dec. 1, 2015, the China Food and Drug Administration (CFDA) announced that the 2015 edition of the Chinese Pharmacopoeia (ChP) has gone into effect. The new edition will drive the overall improvement of drug quality and play a significant role in ensuring drug safety and effectiveness for the public by requiring any drug product and drug ingredient intended for marketing in China to comply with ChP 2015 requirements or use ingredients that comply with ChP 2015 requirements.

    Continue reading »
  • FDA Seeks Human Factors Data

    Mar 10, 2016

    The FDA has issued a draft guidance that lists which devices medical device manufacturers must have human factors data included in their premarket submissions. The Agency believes that inclusion of this data will help it evaluate the potential for use errors in these devices.

    Comments are due May 3.

    Continue reading »
  • CBER Releases 2016 Guidance Doc List

    Feb 29, 2016

    CBER has released the list of guidance documents the Center plans to publish in 2016. Documents of particular interest include early clinical trials with live biotherapeutic products and recommendations for screening donors for Zika in cell, tissue and gene therapy products.

    Continue reading »
  • U.S. Senate Confirms FDA Commissioner

    Feb 25, 2016

    On Feb. 24, the U.S. Senate confirmed Robert Califf, MD, as commissioner of the U.S. FDA. He is currently Vice Chancellor of Clinical and Translational Research at Duke University. His background is in cardiology.

    Califf replaces Margaret Hamburg, who stepped down last year. Stephen Ostroff has been serving as interim commissioner.

    Continue reading »
  • FDA to Delay Some UDI Requirements

    Feb 24, 2016

    On Feb. 3, the U.S. FDA released the draft guidance, Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices. This guidance will outline FDA’s plan to not enforce the prohibition against providing National Health Related Item Code (NHRIC) or National Drug Code (NDC) numbers on device labels and device packages, with respect to certain finished devices manufactured and labeled prior to Sept. 24, 2018 before Sept. 21, 2021.FDA realizes developers need additional time to ensure that unique device identifiers (UDIs) do not include NHRIC or NDC numbers and does not wish to disrupt the supply chain.

    Comments due April 4.

    Continue reading »
  • EMA Sets Up Zika Task Force

    Feb 24, 2016

    EMA has set up a task force to look into the recent Zika outbreak. As part of the Agency's efforts to combat the outbreak, EMA wants input from drug developers working on products that may prove promising in stopping the spread of the disease.

    Continue reading »
  • WHO Releases Biologics GMPs

    Feb 15, 2016

    WHO released a revised set of guidelines for GMPs for biologics in the last quarter of 2015. This set of guidelines accounts for changes since initial recommendations made in 1992.

    Continue reading »
  • FDA Looking at Device Usability

    Feb 15, 2016

    The U.S. FDA recently issued a guidance on applying human factors and usability engineering to medical device due to concerns that user interfaces are designed to minimize or eliminate the risk of errors.

    Continue reading »
  • Anticounterfeiting Tech Now Required in EU

    Feb 15, 2016

    New EU regulations now require new safety features to prevent counterfeiting: a unique barcode and an anti-tampering device for drug products.

    Continue reading »
  • TGA Joins ICH

    Feb 10, 2016

    Australia’s Therapeutic Goods Administration (TGA) has joined ICH as its latest observer, allowing TGA representatives to attend ICH Assembly meetings and participate in ICH activities.

    Continue reading »
  • FDA Continues to Tackle New Tech

    Feb 10, 2016

    The U.S. FDA continues to take steps toward encouraging modernization of pharmaceutical manufacturing, including establishment of the Emerging Technology Team and a recent draft guidance.

    Continue reading »
  • New Agencies Join PIC/S

    Feb 10, 2016
    Effective Jan. 1, the Pharmacy and Poisons Board of Hong Kong SAR (PPBHK) and Croatia’s the Agency for Medicinal Products and Medical Devices (HALMED) joined PIC/S.
    Continue reading »
  • EMA Publishes 2016 Workplan for GMP/GDP IWG

    Feb 5, 2016

    EMA has published its workplan for 2016 for the GMP/GDP Inspectors Working Group. Topics to be discussed during meetings of the working group throughout 2016 include Mutual Recognition Agreements (MRAs), the Joint Audit Programme, data integrity, GMPs for active biological substances, and more.

    Continue reading »
  • Interconnected Devices Need Special Considerations

    Feb 2, 2016

    Medical devices are becoming ever more interconnected with not just other devices but other forms of technology as well. For this reason, on Jan. 26, the U.S. FDA released the draft guidance, Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices. This document outlines the Agency's "specific considerations related to the ability of electronic medical devices to safely and effectively exchange and use exchanged information," and includes considerations that should be included in the development and design processes for these interconnected devices.

    Comments are due March 28.

    Continue reading »
  • 2016 CDER Guidances Cover Wealth of Issues

    Feb 1, 2016

    CDER has released its list of planned guidances for 2016. These include guidances concerning statistical approaches to support a demonstration of biosimilarity, combination products that utilize software, CMC post-approval change documentation and more.

    Continue reading »
  • Three Main Priorities for Devices in 2016

    Jan 26, 2016

    Recently, the U.S. FDA's Center for Devices and Radiological Health (CDRH) released its 2016-2017 strategic priorities. These priorities fall under one of the three following critical areas: establishing a national evaluation system for medical device, partnering with patients and promoting a culture of quality and organizational excellence.

    Continue reading »
  • FDA Reviewing Cybersecurity for Medical Devices

    Jan 25, 2016

    U.S. FDA recently released a draft guidance regarding cybersecurity of medical devices. A growing number of medical devices, such as "smart" devices,  are networked and incorporate software that could be vulnerable to cybersecurity threats. 

    Comments are due April 21.

    Continue reading »
  • EMA Recommends 93 New Medicines in 2015

    Jan 20, 2016
    In 2015, EMA recommended 93 medicines for approval, including 39 new active substances.
    Continue reading »
  • FDA Seeks National Eval System for Devices

    Jan 20, 2016
    Recently, the U.S. FDA's Center for Devices and Radiological Health (CDRH) released its 2016-2017 strategic priorities. These priorities fall under one of the three following critical areas: establishing a a national evaluation system for medical device, partnering with patients and promoting a culture of quality and organizational excellence.
    Continue reading »
  • Q&A Document Addresses QP Template

    Jan 13, 2016

    In December, the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) published a Q&A document summarizing the most common questions asked by stakeholders regarding EMA’s Qualified Person (QP) declaration template and associated guidance document. The Q&A document addresses the QP's role in evaluating the final active substance manufacturer versus factoring in the sites for all raw materials within the supply chain as well as the role of audits from national regulatory bodies.

    Continue reading »
  • FDA Approves Record Number of New Drugs

    Jan 12, 2016
    The U.S. FDA approved 45 novel therapies in 2015—placing overall U.S. drug approvals to their highest level since 1996. More than one-third of these were identified as “first-in-class,” meaning drugs utilizing a new and unique form of action to treat a medical condition.
    Continue reading »
  • China, U.S. to Combat Drug Counterfeiting

    Jan 8, 2016

    At the China-U.S. Joint Commission on Commerce and Trade in Guangzhou, China in late November, both countries agreed to enhance cooperation on efforts to prevent the selling of counterfeit drugs online.

    The U.S. and China also made efforts to work together on drug and medical device registration approval and greater regulation of clinical trials.

    Continue reading »
  • EMA Adopts 4-Year Network Strategy

    Jan 7, 2016

    On Dec. 18, EMA announced that its Management Board and Heads of Medicines Agencies have adopted a network strategy for the next four years. This strategy outlines common challenges and opportunities across the EMA network that pertain to regulating public health, setting out a roadmap for addressing these priorities by 2020. It also builds on EMA’s roadmap to 2015 and the HMA strategy for 2011–2015, and will result in multiannual implementation plans for EMA and related bodies.

    Continue reading »
  • CDER Plans Ambitious 2016

    Jan 6, 2016

    In late December, the U.S. FDA’s CDER office released its 2016 priorities. These include renegotiating parts of PDUFA and GDUFA, a continuing focus on drug compounding and furthering implementation of Track and Trace.

    CDER Director Janet Woodcock also outlined the Center’s 2015 accomplishments. During the past year, CDER stabilized the new Office of Generic Drugs, completed the standup of the Office of Pharmaceutical Quality, established multiple guidances pertaining to pharmacy compounding and responded to congressional queries related to the 21st Century Cures Act.

    Continue reading »
  • precisionFDA Launched

    Jan 5, 2016
    The U.S. FDA launched its precisionFDA platform in mid-December. This Web- and cloud-based portal allows scientists spanning industry, academia and government to collaborate on the science behind next-generation sequencing (NGS) of DNA. The Agency launched this portal as part of the Precision Medicine Initiative, which began in early 2015 and focuses on fostering the development and expansion of personalized medicines.
    Continue reading »