EMEA: ICH Topiq Q8 (R2) Pharmaceutical Development - Note for guidance on pharmaceutical development
This guideline is intended to provide guidance on the contents of Section 3.2.P.2 (Pharmaceutical Development) for drug products as defined in the scope of Module 3 of the Common Technical Document (ICH guideline M4). The guideline does not apply to contents of submissions for drug products during the clinical research stages of drug development. However, the principles in this guideline are important to consider during those stages as well. This guideline might also be appropriate for other types of products.
Źródło wiadomośći: http://www.emea.europa.eu/pdfs/human/ich/16706804enfin.pdf