NICE has a key role in evaluation of and access to new and innovative products for the health system, playing an important role in ensuring the UK remains a destination of choice for the life sciences sector.
We're working closely with the Medicines and Healthcare products Regulatory Agency (MHRA) to make sure we can continue to publish our guidance in a timely way following the transition period.
We aim to publish final guidance for all new technologies within 90 days of receiving marketing authorisation. We will continue to select medical devices for assessment that offer the greatest benefit to the NHS, notified to us through HealthTech Connect.
What will change
- From 1 January 2021, the MHRA will be the UK’s standalone medicines and medical devices regulator.
- For some products, the MHRA will use the Reliance on EU Decisions route, which relies on the opinion of the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA), and marketing authorisation approval decision issued by the European Commission (EC).
- The MHRA is also working with NICE and the Scottish Medicines Consortium (SMC) on an Innovative Licensing and Access Pathway.
What this means
Reliance on EU Decisions route
- The applicant makes an application to MHRA for a GB marketing authorisation, relying on the EMA CHMP positive opinion and the Marketing Authorisation approval decision issued by the EC. Applications should be submitted to the MHRA following receipt of the CHMP opinion and will be determined following confirmation of notification of the EC decision.
- NICE will continue to take account of the EMA process and timetable including issuing draft guidance based on CHMP opinion.
- Arrangements and timing of company submissions to NICE are not impacted by this change.
- Prior to issuing final guidance, NICE will ensure that the MHRA has issued a GB marketing authorisation.
- In circumstances where there is a delay between the EC marketing authorisation and GB marketing authorisation, NICE will delay publication of final guidance.
Innovative Licensing and Access Pathway
We're working with the MHRA, SMC and other partner organisations in the UK to develop approaches to reduce the time to patient access for new medicines that will benefit patients.
The key features of the approach will include a new medicine designation that links to the development of a roadmap to patient access in the UK healthcare system. The roadmap will provide a clear pathway for product development, offering a toolkit of support options and providing a platform for sustained multi-stakeholder interactions.
The toolkit is intended to drive efficiencies in the development programme by supporting data generation and advising on evidence requirements. An integrated pathway will pull together expertise from across the MHRA, NICE and other partners in the wider healthcare system with multiple entry points available to developers. Further detailed information will shortly be published by the MHRA.
What the pharmaceutical industry needs to do
This is an opportunity for NICE and the pharmaceutical Industry to work together and with the MHRA, SMC and other partner organisations to create a joined up regulatory and appraisal process, with an efficient UK access pathway.
To help achieve this, we ask the pharmaceutical industry to:
- engage early
- keep information on UK Pharmascan up to date
- provide updates on regulatory plans to NICE and the MHRA
- allow NICE and the MHRA to share operational and planning data.
What the medical devices industry needs to do
We will continue to work with colleagues at the MHRA to improve access to medical devices in the UK that are registered with the MHRA.
The medical device industry should continue to notify us of important and innovative medical technologies, including devices, diagnostics and digital, through HealthTech Connect.
The new process for regulating medical devices from 1 January 2021 is outlined here: https://www.gov.uk/guidance/regulating-medical-devices-from-1-january-2021