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European Union’s Clinical Trials Directive

BayBiotech.NET
Following is a summary of the key points on the laws, regulations and Good Clinical Practices of the Member States as per European Union’s Directive for conduct of Clinical Trials on human subjects:

1. Directive requires that applications for authorization to place a medicinal product on the market should be accompanied by a dossier containing particulars and documents relating to the results of tests and clinical trials carried out on the product. A dossier must be prepared in compliance with uniform rules laid down by the Member States.

2. A detailed risk assessment and management strategy must be in place based on the toxicological data derived at Pre-clinical research stage.

3. Persons who are incapable of giving legal consent such as dementia, psychiatric patients etc. to clinical trials should be given special protection. Such persons may not be included in clinical trials if the same results can be obtained using persons capable of giving consent. These persons should be included in clinical trials only when there are grounds for expecting that the administering of the medicinal product would be of direct benefit to the patient. However, if possible clinical trials must involve children in order to evolve better treatments for them.

4. In order to achieve optimum protection of health, obsolete or repetitive tests will not be carried out, whether within the Community or in third countries. Such initiatives must be conducted through the International Conference on Harmonization.

5. For Medicinal Products intended for gene therapy or cell therapy, prior scientific evaluation by the European Agency for the Evaluation of Medicinal Products assisted by the Committee for Proprietary Medicinal Products, is mandatory before the Commission grants marketing authorization.

6. Information on the content, commencement and termination of a clinical trial should be available to the Member State where the trial takes place and all the other Member States should have access to the same information.

7. As a rule, if there has been a vote in favor by the Ethics Committee and the competent authority has not objected within a given period, it should be possible to begin the clinical trials. In exceptional cases especially for complex problems/ treatments, explicit written authorization should be obtained.

8. The principles of good manufacturing practice should be applied to investigational medicinal products and for the labeling of these products.

9. The person participating in a trial must consent to the scrutiny of personal information during inspection by competent authorities and properly authorized persons, provided that such personal information is treated as strictly confidential and is not made publicly available.


10. It is also necessary to make provision for the monitoring of adverse reactions occurring in clinical trials using Community surveillance (pharmacovigilance) procedures.


Thus, this provides a snapshot of the key elements of EU’s Clinical Trials Directive. The information provided here is extracted from Official Journal of the European Communities (1.5.2001): L 121/34- 44.

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