The committee's evaluations of marketing-authorisation applications submitted through the centralised procedure provide the basis for theauthorisation of medicines in Europe.

The committees andworking parties also contribute to thedevelopment 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;
  • contributing to the harmonisation of regulatory requirements n the EU and internationally.

For more information, seeWhat we do.

Composition of committees and working parties

EMA's committees, working parties and related groups are composed ofEuropean experts made available by national competent authorities of the EU and EEAMember States.

For a list of national competent authorities in the EEA, see:

The Agency maintains a publicEuropean expert list on all experts who can be involved in EMA work. Experts can only be involved once the Agency has assessed theirdeclaration of interests.

Adopting a committee opinion or recommendation

EMA committees each have their own rules of procedure. To carry out a scientific assessment, usually a committee appoints arapporteur to prepare an assessment report, which the committee will consider and eventually adopt as part of a scientific opinion or recommendation. For certain procedures, a 'co-rapporteur' also prepares an assessment independently from the rapporteur.

Anassessment team supports the rapporteur and co-rapporteur with necessary expertise and resources. The EMA secretariat provides technical, scientific and administrative support for each assessment.

Rapporteurs and co-rapporteurs can establishmultinational assessment teams by including experts from other Member States as well as their own. This is intended to mobilise the best expertise for medicines evaluation regardless of where experts are geographically based. For more information, seeEuropean medicines regulatory network.

Apeer-review process provides additional quality assurance of certain scientific assessments.

EMA committees try to reach their conclusions byconsensus whenever possible, but if not the committee holds avote.For more information, please refer to the below document:

Guidance document on voting in the framework of discussion and adoption of CHMP opinions

Reference Number:CPMP/3137/01 Rev 2

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EMA may exclude committee members from voting on specific issues, in line with EMA 's policy onHandling competing interests.

The working language of all of the EMA committees is English. This includes plenary discussions, working documents and correspondence. EMA does not provide interpretation and translation services.

For more information, see the individual committees' 'Rules of procedure' available on their webpage.

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 ofFees payable to EMA.

What we publish

EMA publishes thedates, agendas, minutes and outcomesof committee meetings on its website. Please find a list of abbreviations commonly used the Agency’s human medicines scientific committees and CMDh documents, including the agendas, minutes and outcomes of committee meetings:

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

Reference Number:EMA/899164/2022 Rev.3

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EMA publishes thedates, agendas, minutes and outcomesof committee meetings on its website. Please find a list of abbreviations commonly used the Agency’s human medicines scientific committees and CMDh documents, including the agendas, minutes and outcomes of committee meetings:

In addition, EMA publishes information on the medicines evaluated by its scientific committees at various stages of the regulatory process, includingpublic versions of scientific assessment reportsand public-friendly information for non-experts.

For more information, see:

Related documents

Principles for publication of agendas and minutes of EMA scientific committees

Reference Number:EMA/555647/2013

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