Committees, working parties and other groups

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The European Medicines Agency (EMA) has seven scientific committees that carry out its scientific assessments. This page provides a general overview of how the committees operate. More details can be found on each committee’s page.

The work of these committees is supported by Working parties and other groups.

Composition

The EMA committees contain members nominated by the medicines regulatory authorities of the European Union (EU) Member States (the ‘national competent authorities’):

Additional members are appointed to each committee based on their expertise and the committee’s rules and requirements; for several committees these include representatives of patients and healthcare-professionals. 

Committees can also call in experts from the European expert list for support on specific scientific or technical matters.

To ensure impartiality, all experts taking part in EMA committee meetings are bound by the EMA's policy on Handling conflicts of interests

Meetings

The committees generally meet once per month at the EMA offices in London, although the HMPC meets once every two months. Most committees do not meet in August.

Meetings usually last between two and four days. The past and forthcoming meeting dates are available on each committee’s page and in the Events and meeting calendar.

Between plenary meetings, committee members and EMA staff liaise to discuss matters related to ongoing assessments and outstanding issues.

Where appropriate, a committee can invite a pharmaceutical company or other third party to present verbal evidence and answer any questions at a committee meeting, as set out in the committee’s rules of procedure.

English is the working language of all EMA committees. This includes plenary discussions, working documents and correspondence. Interpretation and translation services are not provided by the EMA.

Who conducts the scientific assessments?

For most committees, the committee appoints a member to lead each scientific assessment, who is referred to as the rapporteur for the procedure. The rapporteur works to an agreed timetable and prepares an assessment report for the committee. 

For certain procedures, the committee also appoints a ‘co-rapporteur’ to consider the matter in parallel to, and independently from, the rapporteur. The rapporteur and co-rapporteur are supported by an assessment team to provide the necessary expertise and resources.

Rapporteurs and assessment teams are selected based on criteria aimed at ensuring the high quality of scientific assessments and an effective use of resources.  

The EMA secretariat nominates qualified staff to provide technical, scientific and administrative support for each assessment.

For procedures handled by the COMP and PDCO, a committee member is nominated to work together with the EMA secretariat to prepare the scientific assessment report.

Certain scientific assessments undergo an additional quality assurance in the form of a peer-review, whereby other committee members review the scientific evaluation carried out by the rapporteur(s) and the validity of the scientific or regulatory conclusions reached. 

The EMA financially remunerates the national authorities for certain types of work carried out by their staff on behalf of the EMA committees (e.g. as rapporteurs or experts), in the framework of Fees payable to the European Medicines Agency

Adopting a committee opinion or recommendation

EMA committees usually adopt scientific opinions or recommendations at plenary meetings. They do this by consensus whenever possible. If a consensus cannot be reached, the committee reaches a final position through a vote.

Each committee member has one vote (except the chair and members from European Economic Area (EEA) countries, who cannot vote). Detailed voting rules are adopted by each committee, but in all cases at least two thirds of eligible members must be present for a valid vote to take place. Committee members may be excluded from voting on specific issues, based on the EMA policy on the Handling of conflicts of interests.

If a committee member disagrees with the position of his or her committee, this is recorded as a divergent position

The opinions and recommendations adopted by the EMA’s committees are part of decision-making processes that are set out in EU legislation. The detailed steps vary for the different committees and different procedure types. For example, opinions adopted by the CHMP, CVMP and COMP are forwarded to the European Commission, which considers each opinion and can issue legally binding EU-wide decisions

Transparency

The dates, agendas and minutes of committee meetings are published on the EMA website. 

The EMA publishes the agendas and minutes of all its committees since January 2014. This is guided by a set of principles agreed by the EMA Management Board in December 2013:

Further information is published on the outcome of each committee meeting, for example in the form of committee meeting highlights. More details can be found on each committee’s page. 

In addition to meeting-related information, the EMA publishes information on the medicines evaluated by its scientific committees at various stages of the regulatory process, including public versions of scientific assessment reports and public-friendly information for non-experts. For more details, see:

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