Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

DCP Slot Allocation within European Health Authorities and its impact on Development and Regulatory Strategies of Generic Companies Summary

Daniela Meinl (Abschlußjahr: 2011)

Language: English

This Master Thesis shall examine the history and current situation of "Slot Booking" in the context of the Decentralised Procedure (DCP) within the regulatory framework for the registration of medicinal products in the European Union with a special focus on the impact these developoments had on the drug product development and regulatory strategies of generic companies.

The introduction of the Decentralised Procedure with the Directive 2004/27/EC amending Directive 2001/83/EC led to a complete re-organisation of processes and workflows for new applications of medicinal products in Europe both for the competent authorities and the pharmaceutical industry.

In the first part of the Master Thesis the general aspects of the drug product development of a generic medicinal product will be outlined and the importance of launching a generic medicinal product on Day 1 after the Patent expires will be discussed.

After a short summary on the Decentralised Procedure, the second part will focus on the issues both competent authorities and the generic industry were facing along the implementation of this new procedure. It will be discussed why and to what extent ressource issues became such a problem and what impact the new lead-times for submissions have had on the generic industry in the organisation and planning of their drug product development.

Apart from the necessity of the introduction of "Slot Booking" also the impact this had on the regulatory strategies of generic companies will be shown. The different slot booking procedures of the four major Reference Member State (RMS) countries in Europe today will be outlined with the respective advantages and disadvantages.

The third part will demonstrate how the affected parties within the European Union, namely the competent authorities, represented by the Heads of Agencies (HMA) and the Coordination Group for Mutual Recognition and Decentralised Procedures (CMD(h)) and the pharmaceutical industry, represented by the European Generics Association (EGA), the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Association of the European Self-Medication Industry (AESGP) have been working together in order to resolve the issue. What results have been achieved to date and which issues still remain unresolved, especially with regards to "Slot Cancellations".

The Outlook of this Master Thesis tries to show up different possiblities to optimise the existing system of slot booking for Decentralised Procedures in Europe by introducing a harmonised request date and a central coordination for slot allcoation by the CMD(h) in order to reduce the amount of slot cancellations and therefore free up unused capacities.

Pages: 53