European health technology assessment and regulatory concurrent advice

Our European health technology assessment and regulatory concurrent advice service is designed to provide scientific advice from NICE within similar timelines to the EMA scientific advice process.

Companies can use it when:

  • They've requested regulatory advice from the European Medicines Agency (EMA) and need advice from NICE at the same time.
  • They've requested a European parallel consultation with the European Network for Health Technology Assessment (EUnetHTA) and been rejected.

We can also offer advice in collaboration with the Medicines and Healthcare products Regulatory Agency (MHRA), following the same process.

EMA process

  1. the company submits their draft briefing book (optional)
  2. the company submits their final briefing book
  3. the EMA share a list of issues with the company
  4. a face to face meeting takes place with the company and the EMA
  5. the company receives written advice from the EMA.

Our process

  1. the company signs a contract with us
  2. the company submits the same briefing book and we give them a quote
  3. the company submits their final briefing book and we confirm the project fee
  4. we share a list of issues with the company
  5. option 1: a face to face meeting takes place with the company and NICE, to coincide with the EMA meeting
  6. option 2 (after receipt of the EMA advice report): a face to face meeting takes place with the company and NICE
  7. three to four weeks later: the company receives written advice from NICE.

How long does it take?

We work alongside the key dates for the EMA scientific advice process.

Find out more

If you've any queries, please contact our scientific advice team.