Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials
The guideline addresses the specific documentation requirements on the biological, chemical and pharmaceutical quality of IMPs containing biological / biotechnology derived substances.
Read the news announcement published by the European Commission on 14 February 2022.
OpenEdition vous propose de citer ce billet de la manière suivante :
lsgilbert (15 mars 2022). Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials. ELSIBI. Consulté le 16 mars 2026 à l’adresse https://doi.org/10.58079/o5wr





