Development, marketing and assumption of responsibility of the vaccines in France

The development of the vaccines

The evaluation of a vaccine is identical to that of a drug. The file includes/understands a chemical, pharmaceutical, and biological documentation with, if necessary, a viral safety study, a toxicological and pharmacological documentation, a clinical documentation.
European recommendations are elaborate specifying the studies to be realized during the development of a vaccine.

The studies at the man are preceded by a preclinic phase of development including/understanding of the pharmacological and toxicological studies. These studies make it possible to check harmlessness, the immunogenic capacity and the tolerance on various animal species by using the same route of administration as that recommended at the man.

As for any proprietary medical product, the development of a vaccine is based on clinical studies which proceed in 3 phases (phases I to III). However, there always does not exist of clear differences between these phases in particular for phases II and III. The pharmacological studies (phases I and II) evaluate in particular the characteristics of the answer immune, the interaction with other vaccines, the relation dose/réponse, the diagram of vaccination.

The immmunogenicity and the tolerance are evaluated during phases I to III and the protective effectiveness primarily during phase III. The studies of phase IV are studies carried out after the marketing of the vaccine.
The marketing authorization is delivered only after one evaluation of quality, the effectiveness and the harmlessness of the vaccine, i.e. of an appreciation of the bénéfice/risque report/ratio.

The marketing authorization

Procedures of recording of the drug
The two European procedures are the procedure centralized and of mutual recognition.

·         Centralized procedure
Coordinated by the European Agency for the evaluation of drugs (EMEA), it is obligatory for the products resulting from biotechnologiques processes (list A) and optional for the innovating products (list B). The applicant submits a dossier to the European Agency, the scientific opinion (opinion) is returned by the Committee of the proprietary medical products (CSP). The administrative decision is allocated to the European Commission of Brussels after official consultation of the states (Standing Committee). The granted AMM in a centralized way is constraining for all fifteen Member State of the European Union.
The evaluation in centralized procedure is the public report/ratio object, European Public Assessment Report (EPAR). 

·         Procedure of mutual recognition
It allows the recognition by one or more Member States of the marketing authorization granted by a Member State.
The recording is done initially in only one Member State (Member State of reference), the AMM is then recognized by one or more other Member States concerned. As for a national procedure, the deposit of the file is carried out in each Member State concerned, the scientific opinion is given by the Commission of AMM and the administrative decision is under the responsibility of the French Agency of medical safety of the products of health. The AMM is granted in a national way. It includes/understands the national decision, the summary of the characteristics of product (CCP) harmonized between the States concerned at the end of the procedure of mutual recognition, the note and labelling in conformity with the national legislation.

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