The Medicines and Healthcare products Regulatory Agency recently published a Corporate Plan outlining their strategic priorities for the next three years. A key area of focus is international recognition, which follows their May 2023 announcement of new recognition routes which will facilitate access to novel medicines approved by global trusted regulators.
Having transitioned from a member of the European regulatory network to a sovereign regulator, the MHRA has had to place more emphasis on developing and maintaining strategic partnerships to enable continuous and safe access to medicines/medical devices. They have pledged to ensure a collaborative regulatory environment through maintaining active membership in global initiatives such as the International Medical Device Regulators Forum and the International Coalition of Medicines Regulatory Authorities.
Membership to the Access Consortium- which aligns regulatory and policy approaches, creating an attractive market for international companies- and a bilateral partnership with Project Orbis, a streamlined oncology drug programme, have spring boarded the UK’s access to lucrative international partnerships with Australia; Canada; the European Union; Switzerland; Singapore and the United States. These new regulatory recognition routes will allow the UK to access cutting-edge medicines whilst maintaining sovereignty by screening all ‘recognition route’ applications.
One key action is to legislate on Point of Care Manufacture- a highly personalised approach to medicine, requiring manufacture and supply in the healthcare setting where it is to be delivered or administered. The consultation was published in January 2023 and aims to create a regulatory framework based on internationally accepted pharmaceutical principles, enabling the increased manufacture of point of care products whilst retaining safety, quality and efficacy. In line with this action is the drive for international regulatory progress in innovative areas such as artificial intelligence and in silico generation. The latter of which serves to solve a fundamental issue in biomedical research- a lack of available bio samples.
The Corporate Plan is intended to be a ‘high-level road map’ setting out relevant strategic priorities. More in-depth business plans will be published annually alongside key actions for the financial year. In assuring delivery of the plan, the MHRA has held the Executive Committee responsible. They will report on the progress and mitigation risks quarterly in the publically held MHRA Board.
