Meeting of the Joint Sectoral Group (JSG) on Pharmaceuticals

Report

On Friday 16 November 2018 by videoconference, the Directorate-General for Health and Food Safety (DG SANTE), European Medicines Agency (EMA) and Health Canada (HC) held the first meeting of the JSG on Pharmaceuticals under CETA.  Discussion topics included:

1. CETA GMP Protocol and related Administrative Arrangements

The JSG confirmed the continued mutual recognition of GMP inspections and batch certification between EU and Canada for medicinal products for human use and veterinary medicines.

The JSG adopted the Rules of Procedure (ROP) with the understanding that they could revisit as necessary their decision in the future, if there is a need to adapt them to better align with JSG activities. In addition, six administrative arrangements to facilitate the effective implementation and monitoring of the CETA GMP Protocol were approved in principle and are expected to be adopted early in 2019. These administrative arrangements are:

  1. Components of the Information Sharing Process
  2. Two-way Alert Program
  3. Procedure for Evaluating New Regulatory Authorities
  4. Equivalence Maintenance Program
  5. Components of a GMP Compliance Program
  6. Contact Points

2. Recognition of the Active Pharmaceutical Ingredients Program under the CETA GMP Protocol on Pharmaceuticals

Possible extension of the scope to include GMP inspections of active pharmaceutical ingredient manufacturers was discussed.  Officials will meet to develop an approach and timeframe.

3. Canada’s Proposal on Mutual Recognition Agreement (MRA) for Drug Facility Inspections in third countries (re: CETA Regulatory Cooperation Forum (RCF))

Possible extensions of the scope to include GMP inspections conducted in third countries was discussed.  Regulatory authorities in EU and Canada can continue to reduce duplication of inspections in each other’s territory while maintaining high standards of drug product safety and quality and are examining the possibility to extend this recognition to inspections outside their respective territories. Officials will further advance and propose a plan.

The DG SANTE, EMA and HC agreed to a number of action items related to the advancement of the topics discussed above.

The results of the meeting will be reported to the CETA Joint Committee via the CETA Committee on Trade in Goods.

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