The EMA has released the following guidance documents:
- Scientific guideline: Draft guideline on safety and efficacy follow-up and risk management of advanced therapy medicinal products rev 1 (under public consultation until 30 Apr 2018)
- CHMP Guideline on strategies to identify and mitigate risks for first-inhuman and early clinical trials with investigational medicinal products rev1 (Final, 01 Feb 2018)