Committee for Medicinal Products for Human Use (CHMP)
The Committee for Medicinal Products for Human Use (CHMP) is the European Medicines Agency's (EMA) committee responsible for human medicines.
The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.
The CHMP plays a vital role in the authorisation of medicines in the European Union (EU). In the centralised procedure, the CHMP is responsible for:
- conducting the initial assessment of EU-wide marketing authorisation applications;
- assessing modifications or extensions ('variations') to an existing marketing authorisation;
- considering the recommendations of the the Agency's Pharmacovigilance Risk Assessment Committee on the safety of medicines on the market and when necessary, recommending to the European Commission changes to a medicine's marketing authorisation, or its suspension or withdrawal from the market.
The CHMP also evaluates medicines authorised at national level referred to EMA for a harmonised position across the EU. For more information, see Referral procedures.
In addition, the CHMP and its working parties contribute to the development of medicines and medicine regulation, by:
- providing scientific advice to companies researching and developing new medicines;
- preparing scientific guidelines and regulatory guidance to help pharmaceutical companies prepare marketing authorisation applications for human medicines;
- cooperate with international partners on the harmonisation of regulatory requirements.
The CHMP's assessments are based on a comprehensive scientific evaluation of data. They determine whether the medicine meets the necessary quality, safety and efficacy requirements and that it has a positive risk-benefit balance.
An internal peer-review system safeguards the accuracy and validity of the opinions of the committee.
For full details, see: