![]() ĮMA's Committee for Medicinal Products for Human Use ( CHMP) is responsible for conducting the assessment of a human medicine for which an EU-wide marketing authorisation is sought. In the EU / EEA, approximately 4,000 clinical trials are authorised each year.Īpproximately 60% of clinical trials are sponsored by the pharmaceutical industry and 40% by non-commercial sponsors, mainly academia.įor more information, see Clinical Trials Regulation. clinical trials conducted outside the EU / EEA have to comply with ethical principles equivalent to those set out in the EEA, including adhering to international good clinical practice and the Declaration of Helsinki.clinical trials conducted in the EU / EEA have to comply with EU clinical trial legislation.Regardless of where they are conducted, all clinical trials included in applications for marketing authorisation for human medicines in the European Union (EU) / European Economic Area (EEA) must have been carried out in accordance with the requirements set out in Annex 1 of Directive 2001/83/EC. The regulation of clinical trials aims to ensure that the rights, safety and well-being of trial participants are protected and the results of clinical trials are credible. the use of affected clinical trial results for regulatory purposes.Ĭlinical trials are studies intended to discover or verify the effects of one or more investigational medicines.methodological aspects relating to their trials. ![]() Sponsors can also contact either EMA or the national competent authorities for scientific advice on: Questions relating to national guidance should be addressed to the relevant national authority. Sponsors with specific questions relating to EU guidance can contact EMA using the Send a question form.
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