as rapporteurs or experts), in the framework of Fees payable to EMA. EMA does not provide interpretation and translation services.įor more information, see the individual committees' 'Rules of procedure' available on their webpage.ĮMA financially remunerates the national authorities for certain types of work carried out by their staff on behalf of the EMA committees (e.g. This includes plenary discussions, working documents and correspondence. The working language of all of the EMA committees is English. For more information, see European medicines regulatory network.Ī peer-review process provides additional quality assurance of certain scientific assessments.ĮMA committees try to reach their conclusions by consensus whenever possible, but if not the committee holds a vote.ĮMA may exclude committee members from voting on specific issues, in line with EMA 's policy on Handling competing interests. This is intended to mobilise the best expertise for medicines evaluation regardless of where experts are geographically based. Rapporteurs and co-rapporteurs can establish multinational assessment teams by including experts from other Member States as well as their own.
The EMA secretariat provides technical, scientific and administrative support for each assessment. For certain procedures, a ' co-rapporteur' also prepares an assessment independently from the rapporteur.Īn assessment team supports the rapporteur and co-rapporteur with necessary expertise and resources. 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. Adopting a committee opinion or recommendationĮMA committees each have their own rules of procedure.
Experts can only be involved once the Agency has assessed their declaration of interests. The Agency maintains a public European expert list on all experts who can be involved in EMA work. National competent authorities (veterinary).Committee on Herbal Medicinal Products (HMPC)Ĭomposition of committees and working partiesĮMA'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.įor a list of national competent authorities in the EEA, see:.Committee for Orphan Medicinal Products (COMP).Committee for Veterinary Medicinal Products (CVMP).Pharmacovigilance Risk Assessment Committee (PRAC).
Committee for Medicinal Products for Human Use (CHMP).contributing to the harmonisation of regulatory requirements n the EU and internationally.įor more information, see What we do.preparing scientific guidelines and regulatory guidance to help pharmaceutical companies prepare marketing authorisation applications.providing scientific advice to companies researching and developing new medicines.The committees and working parties also contribute to the development of medicines and medicine regulation, by: The committee's evaluations of marketing-authorisation applications submitted through the centralised procedure provide the basis for the authorisation of medicines in Europe. 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.
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