Not There Yet: Concerns Persist On Appropriate Format Of EU GMP Guide For ATMPs

Does it really matter whether a regulatory guidance on a specific topic is presented as a stand-alone document or as an annex to an existing document on the same topic? In the EU, this has become a major sticking point with respect to new guidance on good manufacturing practice requirements for advanced therapy medicinal products being developed by the European Commission. Industry favors the annex option.

The commission's draft GMP guideline for ATMPs, which was re-issued for public consultation earlier this year, has again drawn a significant number of comments from affected stakeholders on how the guidance document should be formatted, ie stand-alone vs annex. The first round of consultation on the draft guideline also drew similar comments from stakeholders with respect to the document's format