Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Comparison of marketing authorization procedures for biotechnological products in the European Union (centralized procedure) and in Japan (J-NDA) ***

Dr. Beatrix Metzner (Abschlußjahr: 2008)

Language: English

Japan is the second largest pharmaceutical market behind the US and a highly developed country. Therefore pharmaceutical companies try to develop medicinal products more or less in parallel in the major markets of the US, EU and Japan with the goal to receive approval for marketing authorization within a short timeframe in all three regions.

To simplify the general life cycle management a harmonized dossier approach would be of advantage. Nevertheless it is not always possible to harmonize the complete dossier due to regional requirements. Whereas the quality overall summary (QOS) of Module 2 is the main review document for Japanese authorities it is used as summary and introduction document for Module 3 in the EU. In Japan it is expected that the applicant summarizes all critical data from Module 3 together with a sufficient discussion on every critical point for ensuring the quality of the medicinal product. There are specific guidelines and rules how to prepare such a dossier to meet Japanese requirements. A summary of the information provided in the QOS has to be listed in the Application Approval Form (AAF). The items described are attached to the license and therefore binding.

For biotechnological products the centralized procedure (CP) is the mandatory procedure in Europe. Timelines given for the CP are more stringent compared to the Japanese New Drug Application (J-NDA) procedure which ultimately leads to shorter timelines for the CP compared to the J-NDA procedure. CP takes about 1 year whereas the J-NDA can last up to 2 years. Special requirements have to be fulfilled for biotechnology products. These requirements are comparable for an European Marketing Authorization Application (MAA) and a J-NDA, respectively, since they are based on the same ICH guidelines. Nevertheless additional guidelines and requirements apply for Japan. There are defined strict rules for the sourcing of biological ingredients.
The present master thesis is focusing on the comparison of the European CP and the J-NDA. Special requirements which have to be taken into consideration when dealing with biotechnology products are included.

Pages: 46