Posted on 04 Apr 2018

Regulatory News - April 2018

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)