FDA and the European Medicines Agency (EMA) published the "EMA–FDA joint Q&As on Quality and GMP aspects of PRIME/Breakthrough therapy applications" document supporting quality development for FDA’s Breakthrough Therapy (BT) designation and EMA's Priority Medicines (PRIME) scheme programs for patients with unmet medical needs. The four sections in the document are representative of the FDA's Center for Drug Evaluation and Research (CDER) policy on the topics and are consistent with CDER's Manual of Policies and Procedures (MAPP) on quality assessments for expedited products (MAPP 5015.13), and the FDA guidance documents referenced therein.

These Q&As are a direct result of a 2018 workshop held by both FDA and EMA where regulators and industry discussed quality challenges and scientific and regulatory approaches for facilitating development and preparation of pharmaceutical quality data packages. These conversations focused on enabling timely access to medicines for patients while keeping in mind the importance of drug safety, efficacy, and quality and maintaining current regulatory standards of approval. FDA and EMA have engaged in further discussions on these topics, sharing their experiences and regulatory expectations in the context of PRIME/BT applications, and this new document is the result of these discussions.

• Annex 1. Q&A on Control strategy considerations for PRIME/BT applications
• Annex 2. Q&A on Process validation approaches for PRIME/BT applications
• Annex 3. Q&A on Alternatives for determination of re-test period or shelf-life for PRIME/BT applications
• Annex 4. Q&A on GMP considerations for PRIME/BT applications