| Abstract Objective: To provide the updates of regulatory for pharmaceuticals and medical devices in the UK after Brexit and give useful references for bilateral trade cooperation and regulatory scientific research. Methods: By consulting the website of Medicines and Healthcare products Regulatory Agency（MHRA）and the related guidance for regulatory of pharmaceuticals and medical devices published by the MHRA after Brexit, the major reforms and status quo of regulatory system and mechanism of pharmaceuticals and medical devices are collected, including institutional responsibilities, organizational structure, legal basis and regulatory mechanism. Result and Conclusion：The UK appointed MHRA as a central level regulatory agency for pharmaceuticals and medical devices, and corresponding regulatory laws and mechanism had also been adjusted after Brexit. However, it is notable the implementation of the Northern Ireland Protocol, as an important part of the Brexit Agreement, makes the regulatory for pharmaceuticals and medical devices in Northern Ireland still applicable to EU regulations, which is different from that in Great Britain. On the other hand, a series of reforms in the UK, such as introduction of reliance models for the EU approval Procedure, overseas multi-center data mutual recognition and collaborative approval, reflected scientific and flexible regulatory approach and improved the efficiency and quality of the evaluation and approval, which is worthy studying and use for reference. |