FDA and EU Regulators Strategize Future Collaboration

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:

• expansion of patient input during the regulatory process
• strengthening collaboration on international pharmacovigilance including assessment of everyday use of drugs
• aligning scientific approaches to biosimilars
• aligning approaches to development plans for pediatric drugs and organizing a workshop to support those plans
• establishment of a joint working group to support the development of safe and effective drugs for children with rare diseases  
• supporting early access to new medications by sharing information and building on the best available regulatory practices
• developing plans for evaluating and sharing information on inspections of drug manufacturers to enable wider inspection coverage and avoid duplication of efforts
• stressing the importance of data integrity with manufacturers through communication and training.

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.”

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