The European Medicines Agency (EMA) and the U.S. FDA have jointly unveiled the "EMA–FDA joint Q&As on Quality and GMP aspects of PRIME/Breakthrough therapy applications." This initiative aims to enhance the quality development process for the FDA's Breakthrough Therapy (BT) designation and the EMA's Priority Medicines (PRIME) scheme, catering to patients with unmet medical needs.
These comprehensive Q&A documents stem from a collaborative 2018 workshop hosted by both the FDA and EMA. During the workshop, regulatory authorities and industry representatives engaged in discussions addressing quality challenges, scientific approaches, and regulatory strategies to expedite the development and preparation of pharmaceutical quality data packages. Emphasis was placed on ensuring timely access to medicines for patients, all the while upholding stringent standards of drug safety, efficacy, and quality in line with current regulatory approval norms. The ongoing dialogues between the FDA and EMA, reflecting their shared experiences and regulatory expectations related to PRIME/BT applications, are encapsulated in the released documents.
The Q&A document is organized into four sections, each providing insights into the current perspectives of the FDA and EMA on key topics:
- 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 the determination of re-test period or shelf-life for PRIME/BT applications
- Annex 4: Q&A on GMP considerations for PRIME/BT applications
For more detailed information on the ongoing discussions between the FDA and EMA, visit the FDA's International Regulatory Harmonization page.
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