Registration of Active Pharmaceutical Ingredient (API) There are a number of mechanisms for providing information to competent authorities in support of applications for finished drug products, where the information is not the intellectual property of the applicant. In Europe, there are two such mechanisms, both of which are for use by API manufacturers.
Certificate of suitability to a monograph of the European Pharmacopoeia
Active Substance Master File In the United States of America (US), DMFs may be submitted by API manufacturers, or manufacturers of other components of the finished drug product, container, and/or closure.
a) Detail the function and purpose of the European Directorate for the Quality of Medicines
b) Provide a detailed account of the above two mechanisms for registration of APIs in Europe
c) Compare the approach of API registration in Europe with that of the US.
d) Evaluate the implications for biosimilar drugs and whether they fall under this legislation