Module 6

04 October 2024

Experts and Committees

Experts

Members in Committee, working parties, assessment teams, expert groups.

Composition of Committees • 1 member + 1 alternate nominated by each of the 27 EU MSs • 1 member + 1 alternate from EEA countries (NO, IS, LI) • Co-opted members for specific expertise on scientific or technical matters and/or patients representatives • Patient representatives in several committees • Elected Chair and Vice-Chair • 3 years renewable mandate

6 An Agency perspective: the success and failure of a medicinal product in the EU

Classified as public by the European Medicines Agency

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Main tasks of the Committee for Medicinal Products for Human Use (CHMP)

• Determines whether products meet Quality, Safety and Efficacy requirements and ensure that they have a positive benefit-risk balance

• Delivers opinions to the European Commission

- on new medicinal products/variations/renewals/line extensions - on arbitration/referral procedures

• Provides Scientific Advice & guidelines to companies

• Establishes Working Parties, SAGs & Expert Groups

• Interacts with regulators beyond EU (e.g. ICH process)

Delivers scientific opinions to WHO

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• Considers recommendations from other Agency Committees on human medicines 7 An Agency perspective: the success and failure of a medicinal product in the EU

Classified as public by the European Medicines Agency

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