European Commission publishes guideline concerning the quality of biological investigational medicinal products in clinical trials

The European Commission has published a guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials.

The guideline has been prepared in cooperation with the Biologic Working Party and has been adopted by the Committee for Medicinal Products for Human Use (CHMP).

The guideline is placed in Chapter III of the Commission's EudraLex, Volume 10.