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The EMA, FDA, and EC met to plan collaboration on pharmaceutical drug development and evaluation.
On July 14, 2015, the European Medicines Agency (EMA) detailed plans developed during a June 19, 2015 meeting between FDA, EMA, and the European Commission. The meeting was part of the agencies’ continuing collaboration to advance drug development and evaluation.
The collaboration between the agencies over the years has created a sharing of information that includes daily interactions of regulatory working groups, also called “clusters”, that review certain topics. In the June 19 meeting, the agencies decided their future focus cluster would be on the “involvement of patients in the development, evaluation and post-authorization activities related to medicines.” The agencies also decided to continue to collaborate on inspections and data integrity, safety monitoring of drugs, biosimilars, pediatrics, rare diseases, timely access to new drugs, and veterinary medicines.
Specific plans include the following:
The agencies stated in a press release that these in-person meetings “ensure that their collaboration delivers on agreed strategic priorities that promote the safety, efficacy and quality of medicines to the benefit of global public and animal health.”