Article | January 24, 2023

How Do Cell & Gene Therapy Requirements Differ Between FDA & EMA?

By Michael Cooper, Clinical and Regulatory Affairs, Pharmatech Associates


Cell and gene therapies (CGTs) are enabling treatment for life-threatening diseases with previously unmet medical needs. However, these innovative products follow nontraditional routes to approval and sponsors face challenges when demonstrating safety and efficacy.

Patient populations are small for target indications and, for life-threatening indications without approved therapies, it is unethical to administer placebo. As a result, the gold standard, randomized control trial (RCT), cannot be employed. Developing and validating analytical methods can also be particularly grueling for CGTs.

Examine the similarities and differences between how the FDA and the European Medicines Agency approach cell and gene therapies. Where do the regulatory perspectives align and where do they diverge?

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