European Commission Launches Public Consultation on Joint Scientific Consultations for Human Medicines

The European Commission has opened a public consultation for the draft implementing act regarding joint scientific consultations on human medicines under Regulation (EU) 2021/2282 on Health Technology Assessment (HTA). Stakeholders are invited to submit their feedback on the detailed procedural rules outlined in the draft until October 29th.

Key Focus Areas of the Consultation:
Submission of Requests by Developers:

The consultation seeks input on the procedures for developers to submit requests for joint scientific consultations on human medicines under the HTA regulation.
Stakeholder Selection and Consultation:

It outlines how stakeholders will be selected and consulted during the HTA process, ensuring a comprehensive approach to scientific discussions.
Collaboration with the European Medicines Agency (EMA):

The draft also includes provisions on how the European Medicines Agency (EMA) will collaborate with other health technology assessment bodies in evaluating the effectiveness and safety of medicines.
Objective of the Consultation:
The public consultation aims to gather relevant insights and feedback to finalize the implementation of Regulation 2021/2282, enhancing the process for joint scientific consultations in the evaluation of human medicines.

Stakeholders, including healthcare professionals, pharmaceutical companies, and research bodies, are encouraged to provide their contributions to ensure the guidelines are comprehensive and reflective of best practices in the industry.

Source: https://www.aemps.gob.es/informa/la-ce-lanza-una-consulta-publica-sobre-el-acto-de-ejecucion-de-consultas-cientificas-conjuntas-de-medicamentos-de-uso-humano/

Region:  Spain