Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Generic applications in the EU and in the USA - a comparison ***

Sandra Baghestani, geb. Strohhöfer (Abschlußjahr: 2003)

The availability of generic medication is an important issue in the regions EU and USA. Cost explosion in the health care systems heat up the political argumentation on generic products and centre the discussion also within the public.

This master thesis deals with the registration process of generic medicinal products in the EU and in the USA. Due to the limited scope, the thesis focuses on chemical active ingredients, administered as solid oral dosage forms. This product range is supposed to represent the most common and well-known segment of the pharmaceutical market.

The time frame under examination is from submission until approval of the generic product, including a pre-submission period where the regulatory strategy is to be established. The structure of a generic documentation in both regions is illustrated, the different approval processes are described and the requested content of certain parts of the documentation is analysed in more detail. A comparison of both regions is made at the end of each section.

The different structure of the regions, the published guidance provided by the authorities and the nature of the approval process with the involved authorities are the basis for the differences when comparing the submission and review process of generic applications. In both regions the documentation can be filed in the CTD format. The CTD is mandatory in the EU but not in the USA. But even when the format is the same, the content of many sections is different.

The US approach to the assessment can be described as a "bottom-up" system and the EU assessment is mainly a "top-down" system.

Each authority in the EU still has its own peculiarities, requirements and medical school. This is a challenge for many generic applications, especially when the SmPC's of the reference product differ in the Member States. Then it is up to the generic company to somehow try to harmonise them.

In both regions the generic registration process and the whole generic environment is under discussion. The political and public pressure to lower the costs in the health care system and to make affordable medicines available to the public is high.

Summing up, it is not possible to say in general, that the requirements in one region are higher or lower or more reasonable than in the other region - they are different.

Pages: 63
Annexes: 30