Profit from the simultaneous feedback of regulatory and HTA bodies in order to generate your data set in the most efficient way!
- What is new?
EMA and EUnetHTA have promoted their interaction by providing a new joint platform for parallel consultations on evidence-generation plans. Building on previous pilots on HTA-regulatory collaboration the newly established joint procedure replaces the EMA/HTA parallel scientific advice procedure. Whereas the former process, required medicine developers to contact national HTA bodies individually, the EUnetHTA Early Dialogue Secretariat now organises a centralised recruitment, improving coordination, intensifying participation of Member States’ HTA bodies and thus fostering informed decision on national level. Parallel consultations are possible for both initial evidence generation and for post-authorisation data collection.
- When will the new process start?
The first requests will be processed in September 2017. For you we have already gained a deep appreciation of the new procedure by close exchange with the involved parties and by analysing relevant documents and templates.
- What are your benefits?
The new collaborative procedure of EMA-EUnetHTA Parallel Consultation offers a more structured platform to discuss your clinical development program with all relevant stakeholders. Based on this, you will be able to generate the evidence that the authoritative bodies will need to determine the medicine's benefit-risk balance for approval as well as the added value for HTA assessment as efficiently as possible. The exchange with HTA bodies and EMA at the same time will help you gain a mutual understanding, manage expectations in your company, and optimize your market access strategy for the European setting.