The Medicines and Healthcare products Regulatory Agency has announced plans to conduct a review and consolidation of the current medicines legislation. The agency will start the project in the autumn by holding informal consultations with the industry and other groups in order to discover where improvements are most needed.

The Medicines Act, which governs human-use medicines in the UK, dates back to 1968, and over the years it has been subject to numerous amendments and expansions, relating not only to the governance of medicines approved nationally but also arising from European Union legislation. Moreover, the growing number of statutory instruments (SIs) affecting the Act, some of which also have “numerous” additional amending SIs, is making the current legislation unwieldy, and the result is “a very complex and fragmented set of legal provisions,” the agency says.

Through the review, the MHRA aims not only to bring together the present fragmented provisions into a more ordered set but also to look for opportunities to make improvements and simplify the provisions where possible, in order to ensure that it “can feel confident that the legislation under which it undertakes its regulatory functions is comprehensive, supportive of its responsibilities and objectives, and is as comprehensible as possible,” it goes on.

As medicines control is “not an accepted or reserved matter as far as Northern Ireland is concerned,” MHRA officials say they will be working closely with their colleagues in Northern Ireland during the review, in order to ensure consistency and continuity of approach.

Given the size of the project, and the fact that it will be dealing with nearly 40 years’ worth of legislation, the regulator expects the review to take around two or three years to complete, during which time updates will be issued. Through the initial informal consultation, the agency will seek input from industry and external stakeholders on potential areas for reform, in order to help it accurately define the scope of the project, it adds.