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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.

  • FDA Responds to Zika

    Aug 11, 2016

    In a blog post over the summer, the U.S. FDA announced its plans for minimizing the impact of the Zika virus by partnering with other U.S. government agencies, the private sector and the international regulatory community, including the WHO and ANVISA (the Brazilian Health Regulatory Agency) on vaccines and treatments. As of July, 120 FDA staff members are working in response to the outbreak.

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  • New WHO Tech Report Offers Data Management Guidance

    Jul 27, 2016

    The World Health Organization has released Technical Report Series No. 996, which provides guidance on good data and record management practices based on feedback collected at an October 2014 meeting.

    [Editor's Note: Check out PDA's data integrity resource page for more information on this important topic!]

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  • 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.

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  • WHO Publishes Process Val Annex

    Jul 2, 2015

    WHO has published its final guidelines on nonsterile process validation in an appendix to its Technical Report Series 992. It outlines WHO’s support for linking process validation to Quality Risk Management and QbD principles.

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  • WHO Releases Supplements to Temperature-Sensitive Product Guidance

    Jun 17, 2015

    WHO recently published 16 supplements to its 2011 guidance, Model guidance for the storage and transport of time- and temperature–sensitive pharmaceutical products. These supplements offer principal requirements for safe storage and distribution of pharmaceutical products. Topics covered include storage facility design, temperature monitoring, temperature-controlled transport, shipping container qualification, management of refrigerant gases, among others.

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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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  • 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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  • 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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