Posted by Michael Wonder on 02 Aug 2019
FDA & European Medicines Agency collaborate on drug quality and manufacturing data to improve patient access to medically necessary medications
31 July 2019 - The FDA and the EMA are publishing the discussion and main conclusions from a workshop held on November 26, 2018, at the EMA headquarters in London, supporting quality development for the FDA’s breakthrough therapy designation and EMA’s Priority Medicines (PRIME) programs for patients with unmet medical needs.
The workshop between regulators and industry discussed quality challenges and scientific and regulatory approaches for facilitating development and preparation of robust quality data packages, to enable timely access to medicines for patients while keeping in mind the importance of drug safety and quality and maintaining current standards of approval.
Multiple topics were discussed, including process validation, Current Good Manufacturing Practices, control strategies, obtaining required stability data, and the exploration of additional regulatory tools. Industry was able to take the opportunity to share their successes and concerns in this area.
