New MHRA Guidance on Pharma Product Assessment Post-Brexit
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 to UK. Eligibility will include applications seeking an orphan MA approval in Great Britain and those submitted for conditional and full MAs as well as those submitted for approval under exceptional circumstances. Applicants interested in seeking Accelerated Assessment should contact the MHRA in advance of the intended date of submission.
Rolling Review Route
The Rolling Review is a new route for MA applications, intended to enhance development of novel medicines. It does this by offering on-going regulatory input and feedback enabling the applicants to 'get it right first time' and ensuring that applications can be approved as efficiently as possible. Applications for any new active substances including biological products that wish to obtain an MA in Great Britain based on submission of a full dossier to MHRA are eligible for a Rolling Review.
The guidance can be found here.
Comment
This continues to be an uncertain time for businesses in the pharmaceuticals sector, as 1 January sees the start of the next phase after the conclusion of the Brexit transition period. The MHRA position on providing guidance on speeding up processes and how businesses can benefit from expedited processes is to be welcomed.
Through PING (Pharmaceutical Industry Network Group), VWV held a sell-out Conference in association with EMIG last year on how Brexit has affected the pharma supply chain. We heard about regulatory, research, immigration and trade issues; as well as an interesting and uplifting perspective from a European-based industry speaker. Press coverage of the event can be found on PharmaTimes and Pharmafield.