Have you got a big wave of new medical regulations implemented on January 1, 2020?

From January 1, 2020, a wave of new medical regulations will be implemented Among them, we need to pay special attention to 11 new regulations, including pharmaceutical production capacity, imported medicinal materials, import tariffs, medical insurance, etc On November 6, 2019, the official website of the national development and Reform Commission issued the order of the national development and Reform Commission of the people's Republic of China (No 92), and the Guiding Catalogue of industrial structure adjustment (2019 version) (hereinafter referred to as the Industrial Catalogue) was reviewed and approved, and was officially published The Industrial Catalog released on the ground consists of three categories: encouraged category, restricted category and eliminated category, specifically in the field of medicine, involving 8 encouraged categories, 6 restricted categories and 13 eliminated categories In addition, the Industrial Catalog is clearly implemented from January 1, 2020 On December 23, 2019, the Tariff Commission of the State Council issued a notice stating that the import tariff of some commodities will be adjusted from January 1, 2020 China will impose a provisional import tax rate below the MFN rate on more than 850 goods Drugs for asthma control and raw materials for the production of new diabetes drugs have achieved zero tariff In order to reduce the cost of drug use and promote the production of new drugs, the circular requires that zero tariff be applied to the alkaloid drugs used to treat asthma and the raw materials used to produce new diabetes drugs Before that, the tariff rate of alkaloid drugs was 5%, and the tariff rate of atorvastatin calcium and recombinant human insulin was 6.5% and 4% On May 16, 2019, the State Administration of market supervision and Administration issued the revised Measures for the administration of imported medicinal materials There are 35 articles in 7 chapters in the measures, which regulate the application, examination and approval, filing, port inspection, supervision and management of imported medicinal materials, as well as the disposal measures, traceability management and legal liability of imported medicinal materials that do not meet the requirements in all links The measures will be implemented from January 1, 2020, and it is expected that the approval time for imported medicinal materials will be shortened by more than half The tenth edition of the European Pharmacopoeia, published in July 2019, will be updated in the next three years (10.1 to 10.8) The new and revised version of the tenth edition will enter into force on January 1, 2020 On December 27, the State Drug Administration, the Ministry of public security and the national health and Health Commission decided to list remazolam (including its possible salts, unilateral preparations and isomers) into the management of category II psychotropic drugs This announcement shall come into effect on January 1, 2020 On November 28, 2019, the national group information platform released the group standard "general technical requirements for production of human recombinant monoclonal antibody products" jointly drafted by Shanghai drug review and verification center of Shanghai food and Drug Administration and Shanghai Pharmaceutical Industry Association, which will be implemented from January 1, 2020 The group standard of general technical requirements for production of human recombinant monoclonal antibody products is applicable to the whole process of commercial production of monoclonal antibody products, and the clinical trial drugs prepared according to GMP requirements can be implemented with reference This is the first on-site inspection guide for the production of human recombinant monoclonal antibody products in China, and also the "strictest" on-site inspection guide for the production of human recombinant monoclonal antibody products in the history of regulatory authorities after the implementation of the "Drug Administration Law" since December 1, 2019, which complements the domestic and foreign on-site inspection on the production of human recombinant monoclonal antibody products at the regulatory and technical levels Blank, further improve the long-term mechanism of mAb drug supervision On November 28, 2019, the State Medical Insurance Bureau and the Ministry of human resources and social security released the complete version of the 2019 national directory of drugs for basic medical insurance, work injury insurance and maternity insurance, which contains 2709 drugs in total Compared with 2017 edition, 218 drugs were transferred in, 154 drugs were transferred out, a net increase of 64 The new catalogue will be put into effect on January 1 In the new version of the national medical insurance drug catalog, another 70 drugs are added to the ranks of medical insurance reimbursement, and another 27 drugs are "renewed" All 97 drugs will be included in the scope of class B drugs in the medical insurance catalogue Through negotiation of price reduction and medical insurance reimbursement, the individual burden of patients will be reduced to less than 20% of the original level, and even to less than 5% of individual drugs "Interim Measures for complaints and reports of market supervision" will be implemented "Malicious claims" will be limited from next month On November 30, 2019, the State Administration of Market Supervision issued the Interim Measures for handling complaints and reports of market supervision and administration, which clearly stipulated that the market supervision and administration department will not accept complaints initiated by "not purchasing or using goods or receiving services for the needs of daily consumption, or not proving that there is a dispute over the rights and interests of consumers with the respondent" The "professional claim" behavior of malicious complaints in the name of "cracking down on counterfeit" will be regulated The Interim Measures shall come into force on January 1, 2020 On October 26, 2019, the 14th meeting of the Standing Committee of the 13th National People's Congress voted to adopt the password law, which will come into force on January 1, 2020, which marks that China has a special legal guarantee in the application and management of passwords Password technology is a basic technology of network security In the network era, all terminals should adopt password technology The official "appearance" of password is of great significance The password used for general pharmaceutical enterprises is applicable to the scope of "commercial password" of the law On June 14, 2019, the animal husbandry and Veterinary Bureau of the Ministry of agriculture of China issued the code for quality management of veterinary drug production (Revised Draft for comments) This standard is the basic requirement of veterinary medicine production quality management Enterprises can establish higher standards according to the actual situation of products According to the production process and characteristics of different types of veterinary drugs, five more detailed appendixes, including sterile veterinary drugs, non sterile veterinary drugs, veterinary biological products, APIs, traditional Chinese medicine preparations, have been formulated, and the specific production quality management specifications of various products have been clarified, which are more instructive and operable This specification shall be implemented from January 1, 2020 If the veterinary drug production enterprise has obtained the veterinary drug production license before the implementation of this specification, it can continue to produce and operate within the validity period, but it shall meet the conditions of this specification before January 1, 2023.