EMA-FDA Meeting Examines Quality Data Package Preparation Challenges in Early Access Programs

August 2, 2019

The EMA and FDA have released a report on their workshop to discuss possible solutions to quality and manufacturing challenges drugmakers face when developing medicines under early access programs.

The November workshop specifically sought ways to facilitate the preparation of robust quality data packages to help speed up application assessments.

Called Priority Medicines (PRIME) in the European Union and Breakthrough Therapy (BT) or Regenerative Medicines Advanced Therapy (RMAT) in the United States, the early access programs aim to help treatments get to market faster without jeopardizing their safety, quality or effectiveness. But these faster development processes have led to some difficulties in completing quality and manufacturing development and data requirements, the report said.

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