EMA And FDA To Continue Collaboration Following 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.