MHRA Highlights Innovation Support and Other Achievements in Annual Report
The Medicines and Healthcare products Regulatory Agency (MHRA) has published its annual report and accounts, highlighting some of its key achievements.
It has faced a busy year with challenges around Brexit at the forefront. The MHRA has sought to react quickly with a task force to consider the options, planning for all outcomes, but top of the regulator's wish list is to retain a close working partnership with Europe after leaving the EU.
Amongst its other key achievements in the last year are:
- Supporting innovation through its innovation office, the Early Access to Medicines Scheme, the 'one stop shop' for advice on regenerative medicine, its support for manufacturing, and contributing to EU schemes, including PRIME and Adaptive Pathways. It has also contributed to the Accelerated Access Review, and wishes to take the recommendations forward.
- Leading on the EU’s Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action. The MHRA has led a successful Adverse Drug Reaction Reporting (ADR) campaign, with 22 countries participating. It has also launched a notification scheme and introduced Yellow Card safety reporting for electronic cigarette products.
- The Clinical Practice Research Datalink (CPRD) has progressed, working with GP software providers to increase coverage of the population with more linkages of data.
- Developing more formal ties with other regulators, such as signing a Memorandum of Understanding with Swissmedic.
The MHRA has promised to continue to work to the highest levels of excellence and quality, working with and supporting its customers, partners and stakeholders to protect health and improve lives. It has vowed also to ensure that UK regulation is robust, competitive and continues to ensure the quality, safety and efficacy of all medicines and devices, safeguarding an uninterrupted level of public health protection.
Comment
In these changing times, the MHRA - which is already well-respected internationally - is going to need to play an important role in the regulation of medicines and devices. It is fundamental for the success of the pharma and medical devices industry in the UK post-Brexit to have a leading and reputed regulator. Hopefully, the MHRA will continue with its excellent links with the European Medicines Agency, as well as forging further links with other regulators and playing a key role in the world.