Masterstudiengang "Drug Regulatory Affairs"


Application for Marketing Authorisation for a Generic Medicinal Product in Europe, USA and South Korea. Development of a Regulatory Strategy considering the different Regulatory Requirements.

Wiebke Gesine Kamp (Abschlußjahr: 2010)

Language: English

Over the past three decades generics have been at focus in the pharmaceutical industries around the world. Cost pressure on social security systems in combination with every nations mission to make effective drugs available to the public has given rise to a vivid development of the generic market.

Three major regions of todays global generics market are Europe, the United States of America and South Korea. With regard to the high market potential for generic drug products in these three regions it is an interesting option for generic companies to enter these markets in parallel.

One of the foundations for a successful marketing of generic drug products is the regulatory strategy. Considering a companys intention to market a medicinal product in Europe, USA and South Korea it is the duty and responsibility of the regulatory affairs manager to develop strategies covering all three regions. He is in charge of preparation of appropriate documentation considering all specific requirements and of compliance of the provided documentation for submission of the application.

In this master thesis the regulatory systems of Europe, USA and South Korea as well as the specific requirements are presented and compared with each other.

Generally it can be stated that all three regions offer the possibility to obtain a marketing authorisation for a generic product via filing an abridged application and provide respective marketing authorisation procedures.

But despite obvious commonness in the principle of concepts for generics in Europe, USA and South Korea the identified differences are the leading determinant factors for determination of regulatory strategy.

Considering these factors it can be concluded that there is not a regulatory strategy for obtaining a MA for a generic product in Europe, USA and South Korea which can be regarded as the “one-and-only-strategy”. General transfer of one strategy to all regions and to all projects is not possible.

In fact each single region has to be regarded and estimated individually at first. Each region requires its own regulatory strategy. In the second step the regulatory affairs manager has to identify and prove possible similarities in order to use synergetic effects with the goal to find the best possible regulatory strategy for the application of a generic medicinal product in Europe, USA and South Korea.

Pages: 47