Terms and Definitions Related to Active Pharmaceutical Ingredients

Active Pharmaceutical Ingredient-related:

l Active Pharmaceutical Ingredient: The active matter or ingredient, obtained through physical or chemical treatment, or through biotech processes, usually intended to be used in the production of drugs products, biological preparations, or biotech products to exercise pharmacological effects in the diagnosis, treatment, or prevention of disease or to affect the structure and function of the body.

l Mass production batch: A batch of products reflective of the production scale and equipment available at the time of application

l Common Technical Document (CTD): The common technical document format stipulated by the International Conference on Harmonisation (ICH) and meant to govern the materials submitted to the competent authority for review of drug registration, so that they can be presented in a consistent format.

l Declaration of No Change: A declaration provided by an applicant wishing to enclose the CEP document to apply for a lean review of the Drug Master File, meant to state that the enclosed materials are identical to those initially submitted to and approved by the European Directorate for the Quality of Medicines & HealthCare (EDQM).