ICH Q11: development and manufacture of drug substances–chemical and biotechnological/biological entities

The International Conference on Harmonisation (ICH) has endorsed a new guideline concerning the development and manufacture of chemical and biotechnological/biological drug substances. The guideline harmonises the scientific and technical principles relating to the development and description of the drug substance manufacturing process to be included within the Common Technical Document (CTD) and submitted to regulatory authorities in the European Union (EU), Japan and USA. This question and answer is intended to provide the reader with a flavour of the background to the guideline and its relevance for biosimilar and generic drug substances.