Call for Comments - ATMP guideline on safety and efficacy follow-up and risk management
5 February 2018
Revised ATMP guideline on safety and efficacy follow-up and risk management
The revised ATMP guideline on safety and efficacy follow-up and risk management has been released for a 3-month public consultation (deadline of 30th April).
EMA would be pleased to receive any HTA comments in respect of the post-authorisation safety and efficacy studies’ endpoints.