CHMP plays a vital role in the authorisation of medicines in the European Union (EU).
In the centralised procedure, CHMP is responsible for:
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, CHMP and its working parties contribute to the development of medicines and medicine regulation, by:
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.
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.
As of March 2025, EMA publishes information - in Excel format - on the start of the procedures for extension applications and for type II variations that propose an extension of the authorised indication handled in IRIS. This information features in addition to the monthly lists of medicines under evaluation and is published on Medicines for human use under evaluation.
Starting with January 2025, EMA is publishing in Excel format the CHMP agenda annex with the regulatory procedures handled in IRIS. This is a secure online platform for managing product-related scientific and regulatory procedures with EMA. This change follows the transition of the post-authorisation regulatory procedures to IRIS. It is also in the context of the digitalisation of EMA's activities, and will help facilitate data analysis. For more information, see the annex documents in the 'CHMP and CHMP PROM agendas' section on this page.
Before start of Committee plenary.
EMA publishes CHMP agendas since its December 2013 meeting.
After Committee plenary where minutes are adopted.
EMA publishes CHMP agendas and minutes since its December 2013 meeting
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.
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.
After current month's Committee plenary.
16 new medicines recommended for approval; another ten medicines recommended for extension of their therapeutic indications
Five new medicines recommended for approval; another seven medicines recommended for extension of their therapeutic indications
Four new medicines recommended for approval; another 16 medicines recommended for extension of their therapeutic indications
Eight new medicines recommended for approval; one positive opinion for a medicine intended for use outside the EU
Seventeen new medicines recommended for approval; another eight medicines recommended for extension of their therapeutic indications
Leqembi (lecanemab) recommended for treatment of early Alzheimer’s disease