EMA And FDA To Continue Collaboration Following Successful Pilot Programs

The European Medicines Agency (EMA) HQ. The EMA and the US Food and Drug Administration (FDA) are to continue to improve efforts to work together more closely following two successful pilot programs.

The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) are to continue to work together more closely following two successful pilot programs.

The two regulatory bodies cover the US and the EU regions respectively, reports the WSJ.

They said the joint good clinical practice (GCP) inspection pilot program achieved its aims to increase information-sharing and collaboration on inspections relating to clinical trials.

The agencies shared 250 documents relating to 54 different medicines and organized 13 collaborative inspections of clinical trials.

The EMA said these efforts help ensure data submitted for drug approvals is of an appropriate standard.

Increased collaboration is part of the FDA's strategy to ensure the safety and quality of imported products, the WSJ reports.

This is in response to challenges posed by rapidly rising imports of FDA-regulated products and an increasingly complex global supply chain.

The plans were described in the Pathway to Global Product Safety and Quality report.

Calls for the agency to transform the way it conducts business and build upon relationships with regulatory partners around the world were also included in the report.

Deborah M Autor is the FDA deputy commissioner for global regulatory operations and policy, reports the WSJ.

She said, "It is imperative that FDA work closely with its counterparts in order to ensure the safety and quality of products and the integrity of clinical trials. We cannot do it alone.” Australia's Therapeutic Goods Administration has also teamed up with the EMA and FDA on a joint active pharmaceutical ingredients (API) inspections pilot program. The program’s aim was to improve information-sharing and collaboration on API inspections among the participating authorities. Participants shared their surveillance lists and found 97 sites common to all three regions, resulting in the exchange of nearly 100 inspection reports and nine joint inspections, the WSJ reports. Based on the results of the two pilots, the EMA and the FDA have agreed to continue with their collaboration on inspections.
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