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Objective:To analyze the evolution of China′s national-level healthcare sector regulatory policies between 2003 and 2021, and explore the characteristics and patterns of the use of policy instruments at different stages, for references in policy optimization.Methods:The policy documents related to the regulation of the healthcare sector released by the central government were searched from 2003 to 2021 from the policy document database of the State Council using the keywords " medical" " regulation" and " health" " regulation". Based on the analysis framework of " formulation subject-implementation subject-policy tools", such methods as content analysis, social network analysis, and policy tool analysis were used to analyze policy documents and conduct descriptive analysis of data.Results:A total of 236 policies were included in the study.From 2003 to 2008, according to the time progression, a total of 27 documents were issued, with the State Council as the main formulation subject (77.78%, 21/27), and the government as the main implementation subject (100.00%, 27/27). 191 policy tools were used, and the composition ratios of supply-based, demand-based, and environment-based policy instruments were 21.46% (41/191), 30.37% (58/191), and 48.17% (92/191). From 2009 to 2017, a total of 48 policies were issued, the formulation subject was mostly the State Council (93.75%, 45/48), and the implementation subject was still mostly the government (100.00%, 48/48), but the proportion of institutions (25.00%, 12/48), industry organizations (43.75%, 21/48) and the society (37.50%, 18/48) has increased. 500 policy tools were used, and the composition ratios of supply-based, demand-based, and environment-based policy instruments were 17.40% (87/500), 32.00% (160/500), and 50.60% (253/500), respectively.From 2018 to 2021, a total of 161 documents were issued, with the formulation subjects featuring multiple subjects (38.51%, 62/161), with a decrease in the percentage of the State Council′s issuance (22.36%, 36/161), and 157 (97.52%) policies were implemented by the government. 1 140 policy tools were used, and the composition ratios of supply-based, demand-based, and environment-based policy instruments being 18.42% (210/1 140), 34.74% (396/1 140), and 46.84% (534/1 140), respectively.Conclusions:From 2003 to 2021, there was an upward trend in the number of policies issued in the field of healthcare sector regulation in China, and the subjects of formulation and implementation were diversified. But the use of different types of policy instruments was uneven.
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OBJECTIVE：To p rovide policy suggestions for the development and supervision of online drugstores in China. METHODS：By literature review ，the relevant literatures and policy documents about the development of online drugstores were searched，screened and sorted out to summarize the development process of China ’s internet drug trading mode and policy ，analyze the development status of China ’s online drugstores ；on the basis of the development experience of some developed countries ，the suggestions were put forward for China ’s relevant policies. RESULTS & CONCLUSIONS ：China’s medical e-commerce started relatively late ，and the policies related to online drug trading were basically released during last 20 years. The number of online drugstores showed a growing trend. The online drugstores were geographically allocated widely but unevenly. They sold many varieties，and policies on selling prescription medicines were gradually liberalized. These online drugstores provided diverse payment and delivery choices ，but their pharmaceutical service needed to be improved. The development models of online drugstores in the United Kingdom ，the United States and Germany could be referred. According to the current situation of online drugstores in China ， combined with the development mode and operation strategy in foreign countries ，it is suggested to improve relevant laws and regulations，and strengthen legal support ；strengthen the government supervision to ensure drug safety ；use the industrial power to standardize medicine operation behavior ；set up the third part trading platform to promote medical insurance payment.
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Gene editing technology has a broad development prospect in medical research and appli-cation,and it is a frontier hot spot in the field of biomedical research worldwide,especially in the field of be-havioral medicine,making it possible to treat and prevent major diseases such as brain diseases,neurodegen-erative diseases and behavioral psychology diseases. But we must recognize that gene-editing technology poses new threats to bio-security while benefiting humanity. This paper summarizes the development and application prospect of gene editing technology in the field of behavioral medicine,summarizes the ethical and relevant institu-tional problems and international regulatory policies faced by the rapid development of gene editing technology, and finally puts forward relevant regulatory suggestions for the development of gene editing technology.
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@#<p style="text-align: justify;">Herbal products are the mainstay treatment among patients with limited access to conventional medicines and those seeking holistic modalities for health and wellness. Usage continues to increase globally with the growing engagement of science and technology in the scientific and sound development of herbal products. In the Philippines, legislative controls on herbal medicine were established through the creation of the Philippine Institute of Traditional and Alternative Health Care (PITAHC) which aims to include herbal medicine use in the national health care system. This paper aims to review the current regulatory policies on production, registration, promotion, and use of herbal medicines in the country. Current policies provide measures in regulating, implementing, and monitoring of herbal medicines from production to consumption stages. However, improvements based on provisions from international standards can be adopted to guarantee efficacy and safety for public use. Policies are still lacking regarding implications of long-term effects; efficacy on specific populations (i.e. children, elderly, pregnant women); and on potential interactions with other food and drugs. There is also a need to strengthen studies on the environmental determinants influencing the effectiveness of herbal products. Paucity on studies on the cost-effectiveness of herbal medicines is further noted.</p>
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Plants , Complementary Therapies , Herbal Medicine , JurisprudenceABSTRACT
OBJECTIVE:To explore the development status of regulatory policies of biosimilars in foreign countries,and to provide reference for perfecting biosimilars regulatory policies in China. METHODS:Comparative analysis was conducted,con-cerning biosimilar regulations and directories which had been issued by WHO,EMA and FDA,in aspects of biosimilars definition, the choice of reference drug,quality studies,non-clinical studies,clinical studies. RESULTS & CONCLUSIONS:Three common points found in foreign regulatory policies were that:firstly,discrepancies were allowed between biosimilars and reference drugs;secondly,the comparison was itemized between biosimilars and reference drugs on safety and effectiveness,in order to guarantee the reliability of quality research;thirdly,clinical and non-clinical studies were reduced with a premise that similarity is confirmed. Given China's current situation,several parts of policies should be improved,including stressing pertinence of reference drug selec-tion,refining preclinical and clinical study directories and establishing supporting system after listing.