Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Development of Generic Oral Human Medicinal Products Suitable for the Registration in the EU as well as the USA – Different Requirements, Feasibility, Time and Cost ***

Christina Pfaffendorf (Abschlußjahr: 2011)

Summary

Language: English

During the last half century, the health systems in the European countries and the USA have developed rapidly and along with this the medicinal product markets. A huge number of laws have been issued, amended or replaced by the national authorities while the pharmaceutical industry expanded into international markets, facing challenges due to different and increasing legal requirements in the different countries.

Harmonisation of legal requirements with regard to quality, safety and efficacy of medicinal products in Europe started slowly in the mid of the 60th (65/65/EEC) and rapidly since the 90th. Meanwhile the requirements on the documentation for Marketing Authorisation Applications for medicinal products are basically harmonised and allow the submission of one dossier in all EU Member States.

In parallel to the activities within Europe, the International Conference of Harmonisation (ICH) worked at harmonising the requirements for the USA, Europe and Japan since 1990. A great lot has been reached so far, but there is still room for further harmonisation and still some challenges for globally acting pharmaceutical industries.

In parallel to the increasing amount of legal requirements and increasing costs for medicinal product developments, the generic industry emerged, offering low-price products. Along with the development of the generic industry, the originators increasingly protected their products with patents and data exclusivity to build hurdles for generics.

This master thesis deals with the development of generic dossiers suitable for the registration in the EU and the USA as well as with the transfer of available generic dossiers from one to the other region. The differences in requirements of the EU and the USA are pointed out and discussed with special focus on feasibility, time and cost. The thesis concentrates on solid oral human medicinal products with chemically defined API to cover the most common product type of the generic industry.

Intention of this document is to serve as guidance for future projects. A list of questions is provided with points to be considered. These questions are discussed and reference to the relevant legislation and guidelines is provided.

Pages: 73
Annexes: Pages : 143