New Platform for parallel consultation will provide advice to medicine developers and facilitate access to medicines for patients


 

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 new initiative replaces the existing tool for parallel scientific advice by EMA and HTA bodies which 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 CommissionExternal link icon (see notes).

Medicines developers will need to notify simultaneously 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.

EUnetHTA created the Early Dialogues Working Party (EDWP), composed of HTA bodies with demonstrated experience in early dialogues/scientific advice, to ensure high-quality advice and consistency over time.

The main benefits of this new platform will be:

  • increased mutual understanding and problem solving ability through a more structured interaction between EMA and HTA bodies;
  • improved coordination with, and greater participation of HTA bodies, as a result of the creation of an Early Dialogue Working Party and an Early Dialogue Secretariat at EUnetHTA;
  • streamlined logistics for the requesters.

These advantages are expected to lead to more robust outcomes resulting from the parallel consultation on evidence-generation plans for pharmaceuticals.

 

For more information, just click at the following link:
EMA – interaction to align data requirements