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EMA (European Medicines Agency)
- Question
- Hello, I would like to know what is the role of EMA in treatment research? Thank you in advance.
- Answer
- Hello,
The main mission of the European Medicines Agency (EMA, headquarter in London) is: the protection and promotion of public and animal health through the evaluation and supervision of medicines for human and veterinary use.
EMA is in charge of scientific evaluation of marketing authorization request of drugs.
The security of drugs is permanently monitored by the Agency through a pharmacovigilance network. Indeed, the Agency shall apply appropriate measures when reports of adverse effects suggest changes in the benefit / risk balance of a drug.
The Agency also plays a role in the promotion of innovation and research in the pharmaceutical industry.
The EMA provides companies with scientific advice and an assistance for the protocols redaction regarding the development of new drugs.
The Agency also publishes guidance on testing requirements of quality, safety and efficiency.
In 2001, the Committee for Orphan Medicinal Products (COMP) was established and has since been responsible for reviewing designation applications by persons or entities wishing to develop drugs for rare diseases, the "orphan drugs".
Best regards,
Anna Ronayette
- 21.01.2013
