Project timeline

  • First contact

    You agree to a provisional face-to-face meeting date with the EMA and contact us to discuss your proposal.

  • -wk6

    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.
  • -wk2

    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

  • wk1

    Submit your final validated briefing book

    The EMA will provide a briefing book template and guidance.

  • wk4

    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.

  • wk6

    You send your presentation to us ahead of the face-to-face meeting

  • wk8

    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.

  • wk11

    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.