Masterstudiengang "Drug Regulatory Affairs"


Variation to marketing authorisations granted for medicinal products in Asia with focus on the Chemical Manufacturing and Control part based on the currently valid EU variation categories

Yuhong Sun (Abschlußjahr: 2003)

Due to the diversities in Asian countries, international companies face difficulties to immediately oversee variation process in Asian countries or regions. For the companies it is not transparent at first glance how the variation is to be proceeded in their affiliates located in Asia. Is this variation a notification only process or a process which requires approval? How long will the process take? What kind of documents are required? In order to provide a comprehensive overview for these companies for conducting variation in Asia, local guidelines and/or local practices of variations to marketing authorisation granted medicinal products were collected from company perspective, the guideline of variation management from SAR Hong Kong and Singapore were downloaded from local authorities' web-site in Internet. For Taiwan both local variation guidelines and local practices are available. The variation categories are based on EU variation categories and focus on the CMC part of a dossier.

Of course this project has its limitations. First, the information was collected only from company perspective, the information are based on personal experience and guidelines if available. Second, for the countries or regions who have local variation guidelines, allocation of their categories into EU variation categories is a challenge due to differences in definitions and/or mutual understanding.

The collected information was validated by to the records of the changes that have been proceeded in these countries over a period of half a year. Thereby, the collected information was verified to be reliable. This experience also helped to correlate the categories of the local variation guidelines to the categories of the EU variation guidelines.

Pages: 101