Designed for developers of medicinal products and other similarly regulated technologies. Receive advice from NICE, the European Medicines Agency (EMA) and various other European Health Technology Assessment bodies (HTABs) through the EUNetHTA Joint Scientific Consultation procedure.
You can find out more information about the process on the EUneHTA website.
- A 4 hour face-to-face meeting with NICE, the EMA and the invited HTABs.
- A consolidated list of issues from the participating bodies allows companies to prepare for the main points ahead of the meeting.
- Single process to seek advice from multiple European HTA agencies.
In the meeting, there was a high level of engagement and NICE helped facilitate a robust discussion that included addressing follow-up questions and clarifying points that were introduced during the discussion.Project feedback questionnaire
How long does it take?
You can find more information about 2018 key dates on the EUneHTA website.
You agree to a provisional face-to-face meeting date with the EMA and contact us to discuss your proposal.
Optional pre-submission stage
Approximately 6 weeks before the validated briefing book is due, you have the option of submitting a draft briefing package for review by all parties.
This is an opportunity to:
- receive feedback, by teleconference, on the draft briefing book
- discuss the scope, wording and clarity of questions being posed.
You sign and return the contract
This will need to be 2 weeks prior to draft briefing book submission if you opt for the optional pre-submission stage
Submit your final validated briefing book
The EMA will provide a briefing book template and guidance.
You receive a combined list of issues from all parties
Each HTA body identifies a list of issues and discusses them with other HTA bodies and the EMA via a teleconference. A final consolidated list of issues is then submitted to the company by the EMA.
You send your presentation to us ahead of the face-to-face meeting
Meeting with the EMA, NICE and other invited HTA bodies
You attend a 4 hour face-to-face meeting, at the EMA offices in London, to discuss the issues identified in your briefing book and answer the questions posed.
We send you a written advice letter
Approximately 3 weeks after the face-to-face meeting, you receive a written advice letter from NICE answering the questions posed in your briefing book.