Evolution of medicines and healthcare products regulatory agency

Abstract

The evolution of Medicines and Healthcare products Regulatory Agency (MHRA), and the relevant resource allocation are analyzed by reviewing of the legal bases, institution setting, human resource deploying, financial structure, and governance framework of the regulator. The laws and regulations are adjusted to include the relevant EC directives. And the continuous institutional restructuring aims to keep pace with the change in the regulated area and the development of the science and technology, take the advantage of the synergistic effect of the institutions belonging to the regulator, improve the healthcare of the patients whilst keeping the leading position of UK in the relevant area, influence the development of science-led regulation, promote innovation to ensure the safety of the launch of the innovative products, and deliver better public health by integrated approach to pharmacovigilance and risk management. MHRA is an executive agency and operates as a government trading fund; the executive agency is distinct from non-ministerial government departments and non-departmental public bodies which enjoy a real legal and constitutional separation from ministerial control. The centralized regulation of medicine and medical devices is implemented in MHRA. The user fees take the majority in the financial funding of MHRA. The ratios of the human resource deployment and user fees, expenditures, and earnings reflect that the focus of MHRA is on approval, pharmacovigilance, inspection, device, and Clinical Practice Research Datalink (CPRD). The regulatory system for medicines and medical devices of UK provides useful reference for the deepened reform in the relevant regulation in other countries.