Masterstudiengang "Drug Regulatory Affairs"


Established active substances: Process of registration and regulatory strategy for submissions in the EU ***

Dr. Michaela Bleile-Röhrlich (Abschlußjahr: 2001)

Marketing authorisations for established active substances can be granted on the one hand through the mutual recognition procedure and on the other hand through national procedures. Documents and particulars required for applications vary depending on the application type (generic or bibliographic). Generic applications are abridged applications, they refer to a file of an original medicinal product and do not contain results of pharmacological and toxicological tests and results of clinical trials. The principle of essential similarity is effective. One problem for generic application in the mutual recognition procedures is the disharmony of the SmPC's of the originator products in certain Member States. The principle of lowest common denominator for indications (less indications are acceptable) and highest common denominator for safety applies, the other sections must be comparable. The harmonisation of the "generic" SmPC leads to a vertical disharmony between the innovator and generic SmPC in each market.

Three kinds of protective rights of the originator have to be considered by the second applicant: data protection, patent protection and supplementary protection certificate. If no original / reference medicinal product is authorised to which essential similarity can be claimed, the applicant has to submit a bibliographical application. Efficacy and safety are demonstrated by detailed references to published literature. A bibliographical application is possible if the constituents have a well established medicinal use.

Regulatory strategies for the registration of medicinal products include market analysis and a comparative estimation of the already existing marketing authorisations.

The decisions to be made include the number of submissions, in which Member States applications for marketing authorisations should be submitted, which is the suitable authorisation procedure, and which application type should be chosen.

Different possibilities to obtain a marketing authorisation for established active substances through simplified procedures in certain European Member States have to be taken into account. Data compilation is simplified especially for part III and IV of the dossier. The advantage is that the admission procedure is not a lengthy and costly one, the disadvantage is that indications are standardised and that the granted marketing authorisations can not be used as basis for a mutual recognition procedure.

Pages: 29