EMA Steps Up Efforts for Early-Stage Communication

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 07-11-2017 17:12


The European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA) are stepping up their efforts to provide developers of medicines with simultaneous, coordinated advice on their development plans and facilitate alignment of data requirements.

This initiative provides a single gateway for requests for parallel consultations with the EMA and health technology assessment (HTA) bodies in European Union member states on evidence-generation plans to support decision-making on marketing authorization and health technology assessment.

These consultations will be possible for initial evidence generation and for post-authorization data collection, according to the EMA. The objective is to help generate optimal and robust evidence in an efficient development plan that satisfies the needs of both regulators and HTA bodies.

This new initiative replaces the existing tool for parallel scientific advice by the EMA and HTA bodies that required medicine developers to contact member states’ HTA bodies individually. It also builds on previous initiatives and pilots on HTA-regulatory collaboration led by EMA, EUnetHTA, and the European Commission.

Medicines developers will need to notify simultaneously the EMA and EUnetHTA of their intention to request parallel advice. EUnetHTA’s Early Dialogue Secretariat, recently created to facilitate such consultations, will then coordinate the involvement of the HTA bodies that will take part in the parallel advice, taking into account the preferences of the requester.

Source: European Medicines Agency


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