EMA and EUnetHTA step up interaction to align data requirements

EMA

4 July 2017 - A new joint platform for parallel consultation will provide advice to medicine developers and facilitate access to medicines for patients.

The 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 EMA and HTA bodies in the Member States on evidence-generation plans to support decision-making on marketing authorisation and health technology assessment. Not only will these consultations be possible for initial evidence generation but also for post-authorisation data collection. The objective is to help generate optimal and robust evidence in an efficient development plan that satisfies the needs of both regulators and health technology assessment bodies.

Read EMA press release

Michael Wonder

Posted by:

Michael Wonder