Legal Regulatory Overview on UK Medicine and Healthcare Products Regulatory Agency and Its Enlightenment / 中国药房

ABSTRACT

OBJECTIVE：To provide reference for improving the efficiency of medicine regulation in China. METHODS ：The legal nature and functional scope ，regulatory objectives ，methods and legal elements of UK Medicine and Healthcare Products Regulatory Agency （MHRA），and the implementation and effectiveness of the drug regulatory effectiveness improvement plan in the UK were analyzed to put forward the enlightenment for China. RESULTS & CONCLUSIONS ：MHRA belongs to the enforcement agency of UK Department of Health and Social Care ，and its legal responsibility is borne by the Minister of Health. Its functions include the supervision of medicine ，medical devices ，blood transfusion products. Its objectives include the administrative supervision of medicine and medical devices ，the provision of medical information to patients ，and the encouragement of pharmaceutical enterprises to develop new and effective products. Its supervision methods include the supervision of administrative legislation and regulations ，drug early warning ，admission to market and administrative agreement ；the legal elements as openness ， transparence，cooperation and participation guarantee the legitimacy of regulatory actions. MHRA launched the medicine regulatory performance improvement plan in 2005，aiming to reduce unnecessary medicine regulatory burden and achieve moderate ， risk-based，targeted and cost-effective drug regulation. This plan makes medicine regulatory agencies improve efficiency ，reduce burden of pharmaceutical enterprises and protect patients ’health rights and interests. Our country can learn from the experience of MHRA regulatory practice in the UK ，establish modern regulatory concepts such as from passive regulation to active regulation ， from post supervision to risk supervision ，from administrative guidance to cooperative management ，so as to strengthen regulatory responsibility，make full use of modern information technology and big data technology ，so as to improve the efficiency of drug regulation in China and effectively safeguard the public health rights and interests.