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. It plays a vital role in the authorisation of medicines in the European Union. The committee meets once a month. EMA publishes agendas, minutes and highlights of its plenary meetings.
Dutch is available via eTranslation, the European Commission's machine translation service.
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.
Watch this video to learn more about how EMA’s human medicines committee, the CHMP, plays a vital role in the assessment and authorisation of medicines in the EU. ~ 2:24 minutes
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;
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.
CHMP rules of procedure
AdoptedReference Number: EMEA/45110/2007 – Revised 09 February 2024
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.
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.
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.
Members of EMA's human medicines committee
CHMP consists of scientific experts appointed by EU Member States
Abbreviations used in EMA scientific committees and Coordination Group for Mutual Recognition and Decentralised Procedures (CMD) documents, and in relation to EMA’s regulatory activities