Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Comparison of EU-Pharmacovigilance System Master File (PSMF) with US System ***

Dr. Amir Saeed Sheikholeslam (Abschlußjahr: 2013)

The decision of approving a medicinal product is based on its satisfactory balance between benefits and risks within the conditions specified in the products labeling. Due to the nature and limited duration of premarketing evaluations and investigations, the full safety profile of medicinal products can only be known after marketing of the products. The continuously expanding drug safety information in the post-marketing phase, make it necessary for marketing authorization holders to systematically collect and collate their safety information and to update their corresponding pharmacovigilance activities.

Under the previous provision of Detailed Description of Pharmacovigilance System (DDPS) in the European Union, the marketing authorization applications contained the whole safety information and pharmacovigilance data and the marketing authorization holders (MAH) had to submit the variations to implement the needed changes in their pharmacovigilance information. In 2010, the European Union has introduced the concept of Pharmacovigilance System Mater File (PSMF) in its regulations and directives, to ease and to harmonize the procedure of pharmacovigilance activities in the European Community and to reduce the number of unnecessary variations to the marketing authorizations. The DDPS will be gradually phased out to the PSMF. By the transitional time of 2 (for centrally authorized products)/ 21 (for products authorized through other procedures) July 2015, MAH have already maintained and made available on request a PSMF for their authorized medicinal products.

In FDA Code of Federal Regulation, there are some provisions for mandatory archiving and retaining records of adverse reactions to various groups of medicinal product. These records have to be kept in a file and should be ready for inspection by the authorized FDA employees. These provisions show some rudimentary similarities to the concept of pharmacovigilance system master file and its characteristics in the regulations and directives of the European Union.

A better understanding of the specifications of the pharmacovigilance system in the European Union and the United States and a comparison between the two systems would be the aim of this master thesis.

Pages: 46