Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Regulatory Requirements & Cultural Challenges for Registration of Generic, Human, Oral Medicinal Products in Southeast-Asia: A Comparison of Regulatory Efforts Exerting to the Registration Process in Malaysia, Thailand and Vietnam ***

Dr. Marion Tegeler (Abschlußjahr: 2013)

 Language: English

Who really knows, which regulatory efforts have to be overcome for registration of a generic oral dosage form in Southeast Asia? The organisation of the health authorities and the legal constitutions as well as the cultural background in these countries are quite unknown to many pharmaceutical companies in the European Union. Furthermore, what cultural efforts have to be taken into account to ensure a smooth communication practice with the agencies? -Which key requirements have to be considered in order to prepare a suitable dossier and what would be the best performance for a generic registration process? Are there any other requirements that need to be considered in this regard?

In a growing global pharmaceutical market, cultural contributes and cultural intelligence will become more and more important. The cultural historical background of the population, the established political systems and the economic performance of a country, can have a major impact on the conditions and efforts, which exert to a generic registration in these countries. Most generic pharmaceutical companies, who are located in the European Union, cannot really estimate what cultural challenges and regulatory requirements have to be overcome in order to ensure a successful registration of a generic oral dosage form in these Southeast Asian nations.

This master thesis focuses especially on these regulatory efforts and cultural challenges that have to be exerted in order to manage a registration of a generic human oral dosage form in Southeast Asia, by taking three representative countries, Malaysia, Vietnam and Thailand for analyses of these efforts.

Pages: 87, Annexes: 10 pages: 74