These rules, called Good clinical practice, apply to the way they design the studies, how they record their results and how they report these results. Whether they conduct these studies within or outside the EU, developers conducting studies to support the marketing authorisation of a medicine in the EU have to comply with strict rules. However, EMA, in cooperation with the EU Member States, plays a key role in ensuring that medicine developers follow EU and international standards. Medicine developers who wish to conduct clinical trials in the EU need to submit applications to the national competent authorities of the countries where they want to conduct the trials.ĮMA does not have a role in the authorisation of clinical trials in the EU this is the responsibility of the national competent authorities. These tests help us to understand how the medicines work and to evaluate their benefits and side effects. Potential new medicines are tested first in the laboratory and then in human volunteers, in studies called clinical trials.

the Innovation Task Force, a forum for early dialogue with applicants.ĮMA plays a role in supporting research and innovation in the pharmaceutical sector, and promotes innovation and development of new medicines by European micro-, small- and medium-sized-enterprises.ĮMA also has responsibilities for monitoring and mitigating potential or actual shortages of critical medicines caused by major events and in crisis situations.scientific guidelines on requirements for the quality, safety and efficacy testing of medicines.orphan designation of medicines for rare diseases.scientific support for advanced-therapy medicines.scientific advice and protocol assistance.The Agency uses a wide range of regulatory mechanisms to achieve these aims, which are continuously reviewed and improved.

EMA is committed to enabling timely patient access to new medicines, and plays a vital role in supporting medicine development for the benefit of patients.

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