Brief introduction of the drug regulatory organization system in Hong Kong

Hong Kong divides drugs into traditional Chinese medicine and Western medicine and exercises relatively independent supervision The regulatory framework of traditional Chinese medicine is mainly composed of TCM Management Committee and TCM Affairs Department of the Department of health The regulatory framework of Western medicine mainly consists of the pharmacy and poisons administration and the drug Office of the Department of health In addition, the customs and Excise Department is responsible for investigating and punishing the illegal acts of Chinese and Western medicines in violation of the provisions of the commodity description Ordinance and the trademark Ordinance TCM Management Committee (statutory body): established in accordance with the TCM Ordinance, TCM Management Committee is responsible for the formulation and implementation of various TCM regulatory measures There are TCM group and TCM group Its main functions include: to ensure that the practice and ethics of traditional Chinese medicine and Chinese medicine industry reach a sufficient level; to promote professional education of traditional Chinese medicine; to promote and ensure the proper use of traditional Chinese medicine and Chinese patent medicine safety, quality and effectiveness; to coordinate and supervise the activities of traditional Chinese medicine group and Chinese medicine group Chinese medicine department (government department) of the Department of health: it is the government regulatory department for the implementation of the Chinese Medicine Ordinance and the provision of professional and administrative support to the Chinese Medicine Management Committee Its main functions are: implementation of the Chinese Medicine Ordinance; implementation of the Chinese medicine, Chinese medicine regulatory system and Chinese medicine import and export control; provision of professional and administrative support to the Chinese Medicine Management Committee; and responsibility for Chinese Medicine Medicine related public health and education affairs; exchange TCM information with local and overseas institutions or government departments; provide TCM identification services for government departments, etc Pharmacy and poisons authority (statutory body): the pharmacy and poisons authority is established under the pharmacy and Poisons Ordinance to perform the functions required by the Ordinance and its subsidiary legislation, including: dealing with the registration of pharmacists; investigating the conduct of pharmacists and punishing those found to be misbehaved; regulating and issuing pharmaceutical retailer licences; regulating and To issue licenses for wholesalers, importers, exporters and manufacturers of pharmaceutical products; to regulate the sale, purchase, synthesis and distribution of pharmaceutical products; and to deal with the registration and classification of pharmaceutical products There are seven committees under the Council, namely: 1 Examination Committee; 2 Pharmacy and poisons (seller of poisons); 3 Pharmacy and poisons (wholesale license and registration of importers and exporters); 4 Pharmacy and poisons (license) Committee; 5 Pharmacy and poisons (registration of pharmaceutical products and substances: clinical trials and drug test certificates); 6 Poison Committee; 7 Pharmacist internship training committee The committees meet regularly to consider and develop policies and action plans for the implementation of relevant functions Drug Office of the Department of Health (government department): the drug Office of the Department of health is an organization that implements drug-related laws and provides professional and administrative support to the pharmacy and poisons administration It consists of five divisions, namely, the Department of pharmacovigilance and risk management, the Department of drug licensing and the Department of supervision Specific responsibilities: be responsible for monitoring drugs on the market, conducting risk assessment on adverse reaction reports and complaints of related drugs, and implementing the adverse drug advertising Ordinance; implement the provisions of the pharmacy and Poisons Ordinance, the antibiotics Ordinance and the Dangerous Drugs Ordinance, issue licenses to manufacturers, wholesalers and retailers, inspect the premises of the firm, and take samples of drugs Carry out laboratory tests and put forward inspection and control for violators; assess the registration application of pharmaceutical products and deal with the import and export licensing of pharmaceutical products according to the safety level, efficiency and quality of pharmaceutical products Hong Kong Customs (government department): the Hong Kong Customs participates in the supervision of Chinese and Western medicine, and is mainly responsible for investigating and punishing the illegal activities related to the production and operation of Chinese and Western medicine in violation of the trademark Ordinance and the commodity description Ordinance Third party supervision system: to be exact, the third party organization is not part of the drug supervision system But in Hong Kong, a city with perfect credit system and developed industrial organizations, media supervision, industry self-discipline and non-governmental organization supervision have played a very important role in drug safety management Therefore, the third-party organizations are listed in the drug regulatory organization system of Hong Kong First, the media supervision mechanism The media supervision in Hong Kong is ubiquitous and powerful, which plays an important role in promoting the standardized development of the pharmaceutical industry Second, industry self-discipline and regulation mechanism According to incomplete statistics, at present, Hong Kong has more than 10 pharmaceutical industry associations including the Hong Kong Federation of scientific research and pharmacy, the Hong Kong Pharmaceutical Distribution Association, the Hong Kong Association of licensed pharmacists and so on Through providing training, re education and professional technical consulting services for members, the associations and organizations in various fields of the pharmaceutical industry promote the integrity of the pharmaceutical industry and actively play the role of self-discipline in the industry Third, the supervision mechanism of non-governmental organizations Private third-party neutral institutions, represented by the Hong Kong Consumer Committee, play an important role in drug safety supervision The regulations of consumer committee came into effect on July 15, 1977, and the consumer committee has become a statutory body since then The association actively collects, receives and transmits information about goods, services and real estate, actively receives and reviews complaints from consumers of goods and services and provides them with opinions, and takes corresponding actions based on the information obtained to actively provide opinions to the government or public officials, thus continuously promoting the normative development of the whole industry.