MHRA publishes annual report for 2022-2023 31 Jul 2023
The UK Medicines and Healthcare products Regulatory Agency’s (MHRA) annual report and accounts for 2022-2023 was printed on 19 July 2023.
The report outlines achievements during the year, such as its evolution into a ‘One Agency’ organisation, uniting its regulatory, research and standards and clinical data service. It also highlights the piloting of a new pathway for access to innovative medical technology, plus reforms that allow more regulatory flexibility, like overhauling the clinical trials legislation.
In addition, the Early Access to Medicines Scheme (EAMS) was established in law under the Medicines and Medical Devices Act. Under this scheme 47 scientific opinions were given from 65 applications received in the period.
As part of the MHRA’s delivery plan, it took steps to engage and involve patients in its work, inviting consultation from the public on proposed changes to clinical trials and the Innovative Licensing and Access Pathway (ILAP), for example.
Its new Partnership Group also set out to strengthen relationships with healthcare and regulatory organisations in the UK and overseas. Such collaborations led to the Yellow Card biobank launched with Genomics England aimed at identifying genetic factors that contribute to adverse reactions.
Other initiatives to support faster patient access to new medicines included the Innovation Accelerator service, designed to give innovators better access to the MHRA’s scientific expertise and regulatory guidance.
On the international stage, in 2022/23 the organisation became a full participant in the FDA’s Project Orbis, which accelerates access to new cancer medicines. It also became chair of the Heads of Agencies of the Access Consortium of regulators of the UK, Australia, Canada, Singapore and Switzerland. This group oversees working groups building international reliance. Additionally, the MHRA initiated the first phase in the creation of an international recognition framework with Australia, Canada, Switzerland, Japan, Singapore and the US FDA.
However, the report notes that the MHRA faced challenges with high staff turnover, which contributed to its failure to meet core operational performance timelines. These shortfalls are being addressed through the People Strategy 2022-2026, to attract and retain exceptional people, plus measures including prioritising vacancy filling, streamlining training and increasing resources in key areas.
Read the full report here.
The MHRA’s corporate plan for 2023-2026 shows the regulator understands the issues and concerns of the industry, particularly those relating to the timelines for the review of Marketing Authorisations, Variations and Clinical Trial Applications. To be competitive in a global market and to draw in research, development and marketing interest in the UK we need our regulator to be efficient and nimble. As a Consultancy focusing on Regulatory Strategy and Medical Affairs, PharmaMedic has expertise in engaging with the MHRA and advising on the regulatory options available to our clients. For guidance on the changing landscape in medicines regulation and further advice, contact PMC’s expert team via email@example.com or T: +44 (0) 208 168 1668.