Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Comparative Presentation of the Procedure of Active Substance Master File & Certificate of Suitability and the Implication on the Marketing Authorisation Dossier ***

Dr. Susanne Weyel-Schnurrer (Abschlußjahr: 2014)

Summary
Language: English
For every medicinal product to be authorised in the European Community, independent if it is for human or veterinary use, a marketing authorisation application (MAA) is to be submitted to the competent authority before placing the product on the market.
Irrespective of the authorisation procedure, applicants must provide comprehensive data regarding the medicinal product in question to demonstrate its quality, safety and efficacy.
The description of the quality of a medicinal product is included in module 3 of the marketing authorisation dossier according to the requirements of the ICH Guideline M 4 Q “Common Technical Document for the Registration of Pharmaceuticals for Human Use – Quality Overall Summary of Module 2 and Module 3: Quality”.
The data presented in part 3.2.S., “Drug Substance“, regarding the characteristics, manufacturing, testing and stability of the active substance are usually generated by the respective active substance manufacturer. Since the marketing authorisation holder (MAH) of a medicinal product normally do not produce active substances by itself but purchase them from active substance manufacturers, legal framework conditions must exist for such a case, which enables the marketing authorisation holder to demonstrate the quality of the active substance in their authorisation dossier.
As specific information and data, in particular with respect to the synthesis of the active substance, are confidential and constitute company expertise, meaning this information cannot be disclosed to an external company, such as the marketing authorisation holder of a medicinal product. In order to close this gap, the ASMF procedure as well as the option of submitting a Certificate of Suitability to the Monographs of the European Pharmacopoeia (CEP) are available.
The framework of this thesis will investigate the options for using the ASMF procedure as well as the Certificate of Suitability. The different procedures, respective requirements, up to the description of the lifecycle and maintenance will be presented in comparison and the advantages and disadvantages of the respective procedures will be discussed. The implications on the compilation of the marketing authorisation dossier of the medicinal product will be assessed as well.
Pages: 80, Annexes: 2, pages: 3