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Regulatory News

PDA's Regulatory News is a source of pertinent news from all over the globe. This section is set up by distinct parts of the world so you can read what is crucial to you and your company.

Concerns Shared About ATMP GMPs

Apr 26, 2017, 15:26 PM
News Source Link:
https://www.picscheme.org/en/news?itemid=40
RegulatoryNewsDate:
Apr 26, 2017, 15:08 PM

PIC/S expressed concerns about the European Commission’s proposed advanced therapy medicinal products (ATMP) GMP guidelines in a letter dated Feb. 24. In particular, PIC/S is concerned the proposed guidelines will lead to a nonharmonized approach to ATMP GMPs in addition to lowering standards for ATMP GMPs.

regulatory-news-regions:
  • PIC/S
  • Europe