GMP: EMA - requirements for quality documentation concerning biological investigational medicinal products

Already in 2012, the European Commission published a guideline on the quality documentation for IMP in clinical trials. Now on 23 June, the EMA issued a draft \"Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials\". It is open for public consultation from 1 July until 31 December 2016. The new draft should be read in connection with Regulation (EU) No. 536/2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, which came into force on June 20, 2014.