UK Regulatory System - Post Brexit
Our regulatory division was founded to provide expert EU Regulatory Affairs services, to meet centralised, decentralised and national requirements. The focus of the team remains to continue to provide expert EU regulatory consulting services and these services are unaffected by any potential effects of a Hard-Brexit.
Post-Brexit, the UK government has established a stand-alone regulatory system to ensure its citizens have access to safe and innovative medicines. To achieve this the UK regulatory affairs system is being modified, and a number of initiatives are rolling out through 2021, and the situation may evolve further in the final negotiations taking place at the close of 2020. The MHRA will continue to provide an active, agile and innovative presence in the development of global regulatory standards.
Diamond can help market authorisation holders and companies developing medicines to navigate the emerging procedures being established by the MHRA.
Maintaining Regulatory Compliance for Existing Products
For those products currently marketed in the UK, the following services can be provided to maintain regulatory compliance post-Brexit
- Support the conversion of Community Marketing Authorisations (CMAs ) to Great Britain Marketing Authorisations (MAs)
- Support to Grandfathering activities, related notifications, baseline submissions and managing lifecycle changes
- Portfolio review and regulatory strategy
- Variations, renewals, line-extensions
- New packaging information
- In-flight and in parallel MA procedures for products undergoing EU centralised MA assessment
- UK contact point for non-UK established MAHs
The emergence of the expanded UK Regulatory Affiars system provides areas of opportunity for companies developing new and innovative therapeutics. The Diamond team can help companies in the following interactions with the MHRA:
- Scientific Advice
- Regulatory advice from the Innovation Office
- UK MAAs (Accelerated Assessment Procedure, Rolling Review, Adoption of EU commission decisions, Conditional Marketing Authorisations, Orphan Drug Designation Application )
- Regulatory strategy and advice on how to make use of the UK in global clinical development programmes
- Paediatric Investigational Plans (PIPs)
- Clinical trial applications
- Promising Innovative Medicine (PIM) designation
In addition to the topics covered above Diamond also provide support for other related services including:
- Clinical and non-clinical overview writing
- PIL user testing
- eCTD publishing to support activities in ICH regions and Rest of World markets
- Chemistry Manufacturing and Controls documentation support
- Within Diamond Pharma Services we also provide Brexit related PV and Compliance Services
Contact James Wisely for more information about our UK and Brexit related services.
Telephone: +44 (0)7811 198169
Or Email JWisely@diamondpharmaservices.com
Post Brexit Requirements and Opportunities
The Brexit negotiations are ongoing, but the deadline of 1st January 2021 is close. Diamond can provide the services and the agile response to ensure that your portfolio remains in compliance, and that opportunities are realised.