INFARMED gathers European experts to discuss medicines evaluation strategy

INFARMED gathers European experts to discuss medicines evaluation strategy
May 27, 2021

This Thursday, May 27th, INFARMED presided a joint meeting of the Committees for Medicinal Products for Human Use (CHMP) and for Advanced Therapies (CAT) in the scope of the Portuguese Presidency of the Council of the European Union that takes place during the first half of this year.

The initiative brought together more than 100 participants from the Medicines Agencies of the EU/EEA countries and other European entities such as the European Medicines Agency (EMA) and the European Commission.

Participants discussed innovative evaluation methodologies to support regulatory decision making in addition to the implementation of regulations related to therapeutic selection trials.

During the meeting's second half, the CHMP discussed aspects of the Pharmaceutical Strategy for Europe and the methodology for benefit/risk assessment, as well as the future of biosimilars. The CAT had the opportunity to meet the portuguese researchers who are developing an innovative work in the area of advanced therapy drugs. A national clinical experience using CAR-T cells was also presented.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) plays a key role in the authorization of innovative medicines in the European Union (EU). The Committee for Advanced Therapies (CAT) of the European Medicines Agency (EMA) is the scientific committee responsible for the evaluation of advanced therapy medicinal products (ATMPs).

INFARMED is responsible until June for coordinating the set of 20 meetings of the various Committees and Working Groups.

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