The European Medicines Agency (EMA) has seven scientific committees and a number of working parties and related groups which conduct the scientific work of the Agency.

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

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

For more information, see What we do.

EMA's committees

Composition of committees and working parties

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

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

The Agency maintains a public European expert list on all experts who can be involved in EMA work. Experts can only be involved once the Agency has assessed their declaration 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 a rapporteur 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.

An assessment 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 establish multinational 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, see European medicines regulatory network.

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

EMA committees try to reach their conclusions by consensus whenever possible, but if not the committee holds a vote. For more information, please refer to the Guidance document on voting in the framework of discussion and adoption of CHMP opinions.

EMA may exclude committee members from voting on specific issues, in line with EMA 's policy on Handling 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 of Fees payable to EMA.

What we publish

EMA publishes the dates, agendas, minutes and outcomes of 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, including public versions of scientific assessment reports and public-friendly information for non-experts.

For more information, see:

EMA's committees

 

Composition of committees and working parties

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

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

The Agency maintains a public European expert list on all experts who can be involved in EMA work. Experts can only be involved once the Agency has assessed their declaration 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 a rapporteur 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.

An assessment 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 establish multinational 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, see European medicines regulatory network.

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

EMA committees try to reach their conclusions by consensus whenever possible, but if not the committee holds a vote. For more information, please refer to the Guidance document on voting in the framework of discussion and adoption of CHMP opinions.

EMA may exclude committee members from voting on specific issues, in line with EMA 's policy on Handling 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 of Fees payable to EMA.

What we publish

EMA publishes the dates, agendas, minutes and outcomes of 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 CMD documents, and in relation to EMA’s regulatory activities

Reference Number: EMA/899164/2022

English (EN) (403.34 KB - PDF)

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EMA publishes the dates, agendas, minutes and outcomes of 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, including public versions of scientific assessment reports and public-friendly information for non-experts.

For more information, see:

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