What does the EMA do?

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. The Agency uses a wide range of regulatory mechanisms to achieve these aims, which are continuously reviewed and improved. For more information see:

• support for early access;
• scientific advice and protocol assistance;
• paediatric procedures;
• scientific support for advanced-therapy medicines;
• orphan designation of medicines for rare diseases;
• scientific guidelines on requirements for the quality, safety and efficacy testing of medicines;
• the Innovation Task Force, a forum for early dialogue with applicants.

EMA 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.EMA also has responsibilities for monitoring and mitigating potential or actual shortages of critical medicines caused by major events and in crisis situations.