EU: Cooperation of EMA and EC under the Health Technology Assessment Regulation
The European Commission (EC) launched an online public consultation on cooperation with the European Medicines Agency (EMA) under the Health Technology Assessment (HTA) Regulation. The cooperation, which is outlined in a draft implementing act, includes the exchange of information between the Coordination Group on Health Technology Assessment (Member States), the Commission and the EMA.
The draft implementing act provides rules for cooperation with the European Medicines Agency to:
- share information
- plan and forecast joint clinical assessments and joint scientific consultations for medicinal products and medical devices
- identify patients, clinical experts and other relevant experts to be involved in joint clinical assessments and joint scientific consultations.
The draft implementing act also concerns the security and protection of confidential information exchanged between:
- the EMA
- the HTA secretariat
- the Member State Coordination Group on HTA or its subgroups.
The HTA Regulation foresees the adoption of implementing acts, detailing the procedural rules for the different elements in the Regulation. This implementing act is the third of six acts in 2024 for which public consultations will be held.
This online consultation will be open for responses until 24 July 2024.
Source:
EC: Newsroom
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