Masterstudiengang "Drug Regulatory Affairs"


Maintenance of Generic Marketing Authorizations ***

Brigitte Nerl (Abschlußjahr: 2001)

A marketing authorisation is based on a positive opinion of competent authorities concerning safety, efficacy and quality. While innovative medicinal products have to pass a complicated time and cost consuming procedure, the application of a generic drug is mainly based on already existing safety and efficacy data of an original authorisation to which essential similarity could be demonstrated. Data protection categorises these abridged applications in "informed consent applications" and "generic applications". Legislation gives further possibilities for simplified procedures, such as bibliographic application for a "well established medicinal use" of the constituent(s) of a medicinal product, mixed data applications and line extensions.

After a licence has been granted, the holder of the authorisation is responsible for the marketed product throughout its life. European and national legislation demands for renewal applications in five yearly periods since the validity of a licence is limited to five years. The marketing authorisation holder is also required to take technical and scientific progress into account, and to introduce any required changes to assure that the medicinal product is manufactured and checked by means of generally accepted scientific methods. In particular, the responsibility of a marketing authorisation holder includes the increase of a positive benefit risk ratio for an individual product as far as possible. A pharmacovigilance-system regulates the surveillance of medicinal products, with particular reference to adverse drug reactions in human beings, and the scientific evaluation of such information.

This master thesis gives essential and detailed instructions for the workload coming up for maintaining a licence. It reflects the status of legal requirements of June 2001. The main chapters are structured according to the priorities of procedures in generic companies: 1. Marketing authorisations granted by MRP; 2. Nationally granted marketing authorisations (Germany); 3. Re-registrations. The chapter "Pharmacovigilance" is restricted to an overview.

With the European Commissions review of authorisation procedures the requirements for the maintenance of marketing authorisations will change. It is under discussion to reorganise the classification system of variations in line with a shorter time frame and with a reduced workload similar to the German system. For renewals it is intended to abolish the current requirement for marketing authorisation holders to renew authorisations every five years. Monitoring of authorisations will be an ongoing process, with marketing authorisations required to have an up-to-date dossier at all times. The pharmacovigilance system and the PSUR scheme will be strengthened.

Pages: 30