How the committees work
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 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.
- Committee for Medicinal Products for Human Use (CHMP)
- Pharmacovigilance Risk Assessment Committee (PRAC)
- Committee for Veterinary Medicinal Products (CVMP)
- Committee for Orphan Medicinal Products (COMP)
- Committee on Herbal Medicinal Products (HMPC)
- Committee for Advanced Therapies (CAT)
- Paediatric Committee (PDCO)
Composition of committees and working parties
For a list of national competent authorities in the EEA, see:
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.
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.
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.
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: