New MHRA Guidance On Pharma Product Assessment Post-Brexit

• Published date: 12 November 2020
• Subject Matter: Food, Drugs, Healthcare, Life Sciences
• Law Firm: Veale Wasbrough Vizards
• Author: Mr Paul Gershlick

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a guidance note on new assessment routes for pharmaceutical products from the end of the Brexit transition period.

From 1 January 2021, the MHRA is introducing changes to national licensing procedures, including:

• procedures to prioritise access to new medicines that will benefit patients
• an accelerated assessment procedure
• new routes of evaluation for novel products and biotechnological products.

In addition, for two years from 1 January 2021, Great Britain will adopt decisions taken by the European Commission on the approval of new marketing authorisations (MAs) in the community marketing authorisation procedure.

The three key points in the MHRA's guidance are listed below.

Prioritising Access to New Medicines

The MHRA is working with partner organisations in the UK to develop approaches to reduce the time to patient access for new medicines and technologies 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 and partners in the wider healthcare system such as NICE (the National Institute for Health and Care Excellence), with multiple entry points available to developers.

Accelerated Assessment Procedure

The MHRA will have an accelerated procedure whereby it gives its opinion on approvability of MA applications within 150 days of submission of a valid application. The Accelerated Assessment option is available for good quality new MA applications for both new and existing active substances and submitted directly...