NICE have published guidance on what happens if they cannot be part of the parallel advice with the European Medicines Agency (EMA) via EUnetHTA?

  • All existing contracts will be honoured by producing their own advice letter and holding a NICE-specific face-to-face advisory meeting
  • They can provide a service where advice is sought from NICE concurrently with advice being sought from the EMA and other health technology assessment (HTA) bodies. The process in this eventuality is explained in their full article here
  • In addition to advice on clinical trial programmes, NICE can also hold in-depth discussions on modelling questions and provide access to world-class health economic experts
NICE will continue to offer joint advice with the Medicines and Healthcare products Regulatory Agency (MHRA)
Continue reading the full article on scientific advice guidance here