Scientific Committees of the European Medicines Agency (EMA)
The European Medicines Agency (EMA) carries out much of its scientific work through specialised scientific committees. These committees bring together expertise from across the European medicines regulatory network and provide scientific opinions and recommendations on medicines and related regulatory matters.
EMA was historically referred to as EMEA, so the term EMEA may still be encountered in older regulatory documents and educational materials.
Scientific Committees of EMA
EMA currently has seven scientific committees:
Committee for Medicinal Products for Human Use (CHMP)
The CHMP is responsible for preparing EMA’s scientific opinions on questions concerning medicines for human use. It plays a central role in the scientific assessment of medicines submitted through the centralised marketing authorisation procedure.
Pharmacovigilance Risk Assessment Committee (PRAC)
The PRAC is responsible for assessing and monitoring the safety of medicines for human use. Its work covers pharmacovigilance activities including the detection, assessment, minimisation and communication of risks associated with medicines.
Committee for Veterinary Medicinal Products (CVMP)
The CVMP is responsible for preparing scientific opinions on questions concerning veterinary medicines. It evaluates veterinary medicines submitted through the centralised procedure and contributes to scientific and regulatory guidance.
Committee for Orphan Medicinal Products (COMP)
The COMP reviews applications for orphan designation for medicines intended for the diagnosis, prevention or treatment of rare diseases.
Committee on Herbal Medicinal Products (HMPC)
The HMPC supports the harmonisation of regulatory procedures and provisions concerning herbal medicinal products within the European Union. It develops scientific opinions and information relating to herbal substances and preparations.
Committee for Advanced Therapies (CAT)
The CAT provides scientific expertise concerning advanced therapy medicinal products, including gene therapies, somatic cell therapies and tissue-engineered products. It plays an important role in their scientific assessment.
Paediatric Committee (PDCO)
The PDCO deals with the development of medicines for children. One of its principal responsibilities is the assessment of paediatric investigation plans and related applications.
How EMA Committees Work
EMA’s scientific committees consist of experts drawn largely from the national competent authorities of EU and EEA countries. Committees may also be supported by working parties and other expert groups with specialised scientific expertise.
During a scientific assessment, a committee generally appoints experts to evaluate the available evidence and prepare assessment reports. The committee then discusses the evidence and adopts a scientific opinion or recommendation.
The committees also contribute to medicine development and regulation by providing scientific advice, preparing scientific and regulatory guidelines, and supporting harmonisation of regulatory requirements within Europe and internationally.
Importance of EMA Scientific Committees
EMA’s scientific committees provide specialised expertise throughout different areas of medicines regulation. Their work supports consistent, science-based assessment of the quality, safety and efficacy of medicines, as well as continuing safety monitoring after medicines are authorised.
You may be interested in the programs below:
