The Regulatory Framework and the Health Products Agency Afssaps

The new European Directive on clinical trials

To limit our discussion to the clinical trials required for the registration of new drugs, France falls squarely within Northern Europe in terms of recognition of national studies; this is confirmed by the list of the reporting countries for European centralised and mutual recognition procedures leading to European Marketing Authorisation, and of inspections conducted by the Food and Drug Administration for American new drug applications (NDA).The Southern countries have, so far, less experience, notably because of the lengthy administrative procedures required for initiation of clinical trials. The new European Directive on the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use,2 approved in December 2000 by the European Parliament and the Council of Ministers and published as Directive 2001/20/EC, will have to be transposed to the national law of each member state. This law does not include all types of clinical research but, when implemented in the different countries, it will modify the regulatory demand for starting clinical trials on medicinal products, demands to authorities and IECs, and implementation of good clinical practice.

*Landers: states constituting the Federal Republic of Germany 160

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