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EMA, FDA To Address Quality Issues For PRIME/Breakthrough Designation Products

 
• By Vibha Sharma

Experience with early access schemes in the EU and the US – i.e., PRIME and breakthrough therapy designation – has shown that sponsors face challenges in complying with quality and manufacturing data requirements. 

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Workshop Will Include Specific Industry Case Studies And Discussion On Experience Till Date • Source: Shutterstock

The European Medicines Agency and the US Food and Drug Administration are set to discuss the quality and manufacturing-related problems that sponsors face for drugs developed under the regulators’ early access programs, PRIME (priority medicines) and breakthrough therapy designation (BTD) respectively.

The discussion will take place at a workshop on Nov. 26 at the EMA's London headquarters, where the EU regulators, industry, the FDA and other international partners will try...

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