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.

Please see the links below.

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2018/02/news_detail_002897.jsp&mid=WC0b01ac058004d5c1

Guideline on safety and efficacy follow up RMP for ATMP: https://docs.eudra.org/webtop/drl/objectId/090142b283cccb2e