Regulatory Surveillance Summary Winter 2018

European Federation for Cosmetic Ingredients (EFfCI)

No updates noted for EFfCI Good Manufacturing Practice Working Group.

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European Medicines Agency (EMA)

Regulatory Science to 2025 – Launch of Six-Month Public Consultation, 19 December 2018

EMA has published its draft  ‘Regulatory Science to 2025’ strategy for a six-month public consultation . This is a proposed plan for advancing the Agency’s engagement with regulatory science over the next five to ten years, covering both human and veterinary medicines. Stakeholders are invited to send their comments via an online questionnaire by 30 June 2019.  “The Regulatory Science strategy to 2025 aims to build a more adaptive regulatory system that will encourage innovation in human and veterinary medicine,” said Guido Rasi, EMA’s Executive Director. “The strategy includes developments and challenges in medicines development that we together with the Commission and NCAs experts have identified in a thorough process of mapping and selection. Now we want to hear from our stakeholders whether they consider this strategy is ambitious enough.”

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Eudralex – Volume 4 – Good Manufacturing Practice (GMP) Guidelines

Eudralex Volume 4, Annex 2, Manufacture of Biological Active Substances and Medicinal Products for Human Use, Revision 2, 26 June 2018

Annex 2 of the GMP Guide has been revised as a consequence of the adoption of the Guidelines on GMP specific to Advanced Therapy Medicinal Products pursuant to Article 5 of Regulation (EC) 1394/2007 of the European Parliament and of the Council of 13 November 2007 on Advanced Therapy Medicinal Products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004.

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Eudralex Volume 4, Annex 17, Real Time Release Testing and Parametric Release, Revision 1, 26 December 2018

The previous Annex 17 guideline only focused on the application of Parametric Release for the routine release of terminally sterilized products waiving the performance of a test for sterility on the basis of successful demonstration that predetermined and validated sterilizing conductions have been achieved.  Moreover, advances in the application of Process Analytical Technology (PAT), Quality by Design (QbD), and Quality Risk Management (QRM) principles to pharmaceutical development and manufacturing have shown that an appropriate combination of process controls together with timely monitoring and verification of pre-established material attributes provides greater assurance of product quality than finished product testing (conventionally regarded as the end product testing) alone.  This revision of Annex 17 takes into account changes to other sections of Eudralex, Volume 4, Part I, Chapter 1, Annex 1 and 15, ICH Q8, Q9, Q10, and Q11, and the QWP Guideline on Real Time Release Testing, and changes in manufacturing and analytical technology.

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Health Canada

Health Canada’s Action Plan on Medical Devices: Continuously Improving Safety, Effectiveness and Quality, December 2018

Health Canada is implementing an Action Plan to improve the safety and effectiveness of medical devices and to optimize health outcomes for patients.  This Action Plan lays out a three-part strategy, which will be achieved through improving how devices get on the market; strengthening monitoring and follow-up of devices once they are being used by Canadians; and providing more information to Canadians about the medical devices they use.  Collaboration with provinces and territories, and other health care system partners will be fundamental to delivering results.  Health Canada will strengthen and expand existing outreach information activities, as appropriate, to reinforce these important partnerships.  The three-part strategy includes the following elements:

Part I: Improve How Devices Get on the Market

  1. Increase research by medical professionals and increase patient protection – Starting early 2019
  2. Review evidence requirements and expand scientific expertise – Starting January 2019

Part II: Strengthen Monitoring and Follow-Up

  1. Implement mandatory reporting and expand the Canadian Medical Devices Sentinel Network – Starting February 2019
  2. Establish ability to compel; information on medical device safety and effectiveness and expand use of real-world evidence – Starting early 2019
  3. Enhance capacity in inspection and enforcement – Starting 2019

Part III: Provide More Information to Canadians

  1. Improve access to medical device clinical data – Finalized by early 2019
  2. Increase the information on device approvals and publish medical device incident data – Starting January 2019

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