Role of CHMP
CHMP plays a vital role in the authorisation of medicines in the European Union (EU).
Centralised procedure
In the centralised procedure, 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 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.
Referral procedures
CHMP also evaluates medicines authorised at national level referred to EMA for a harmonised position across the EU. For more information, see Referral procedures.
Medicine development
In addition, 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.
CHMP assessments
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. CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.
For full details, see the CHMP rules of procedure and work plan.
Publication of CHMP agendas, minutes and highlights
EMA's Committee for Medicinal Products for Human Use (CHMP) meets once a month. EMA publishes the agendas, minutes and highlights of the plenary meetings. EMA also publishes the agendas and minutes of the CHMP's preparatory and organisational matters (PROM) meeting, formerly known as CHMP's organisational matters (ORGAM) meeting.
The PROM is a meeting to discuss CHMP organisational matters and other topics in preparation for the CHMP plenary meeting. Its name changed from ORGAM to PROM in February 2021.
The Committee has been publishing meeting reports summarising the main outcomes of its meetings since it was established.
CHMP publication times
- Agendas
Before start of Committee plenary.
EMA publishes CHMP agendas since its December 2013 meeting.- Minutes
After Committee plenary where minutes are adopted.
EMA publishes CHMP agendas and minutes since its December 2013 meeting- Meeting highlights
Friday after Committee plenary.
The web-based format of CHMP meeting highlights replaced the PDF format of CHMP press releases and monthly report in September 2011.- PROM agendas
Week before Committee plenary.
As of June 2023, CHMP no longer publishes the PROM meeting agendas. You can find information on the agenda discussed in the PROM meeting minutes.- PROM minutes
After current month's Committee plenary.