Posted by Michael Wonder on 14 Dec 2021
EU regulation passed: G-BA works on European HTA assessment
14 December 2021 - Today the EU Parliament passed the EU-HTA regulation for a joint health technology assessment, which includes, for example, new drugs (including gene and cell therapies), but also medical devices.
As part of the EUnetHTA21 consortium , the Federal Joint Committee (G-BA) is already working with the IQWiG on the basis for the implementation of this regulation. One of the tasks of the G-BA will be to work on process and structural requirements as well as methodological issues for clinical consultations. The clinical evaluation at the European level is to be included in national decisions on the additional benefit of new drugs in the future.
A joint evaluation of cancer drugs and novel therapies (ATMPs) is to start in 2025.
