From January 1, 2020, a number of new medical policies and regulations will be formally implemented

[policies and regulations of pharmaceutical network] in 2020, it has entered the countdown, accompanied by new policies and regulations of various industries Since January 1, 2020, a number of new medical policies and regulations have been officially implemented, which will have a huge impact on the pharmaceutical industry The 2019 version of the medical insurance catalog will be officially implemented From January 1, 2020, the 2019 version of the medical insurance catalog will be officially implemented The 2019 version of the medical insurance catalogue is divided into two parts: routine access and negotiation access Among them, the routine access part includes 2643 drugs, an increase of about 4.3% compared with the 2017 version of the medical insurance catalogue, including 1322 western drugs and 1321 Chinese patent drugs, and a total of 150 varieties are transferred out, including drugs whose number has been revoked by the State Food and Drug Administration and drugs whose clinical value is not high, which are obviously abused and have better substitutes, among which the key ones are supervised by the State Food and drug administration All products in the control catalog are transferred out Since January 1, 2020, China will adjust the import tariff of some commodities It is mentioned that zero tariff should be implemented for some drugs and APIs to further reduce the burden of medication for patients with chronic diseases In the plan, it is clear that zero tariff will be applied to the drugs for asthma treatment and the raw materials for the production of new diabetes drugs, such as engliptin, liggliptin and viggliptin According to the industry, at present, COPD has become a chronic disease equivalent to hypertension and diabetes, and the demand for drugs is increasing The implementation of zero tariff on this part of drugs and APIs can reduce the burden on patients "Ramazolam" is listed in the second category of psychotropic substances management According to the relevant provisions of the regulations on the administration of narcotic drugs and psychotropic substances, ramazolam (including its possible salts, unilateral preparations and isomers) is listed in the second category of psychotropic substances management, and the new regulations will be implemented from January 1, 2020 According to the data, remazolam is a short acting GABAA receptor agonist developed by paion company in Germany, which is usually used in general anesthesia during operation Antibody drugs, gene therapy drugs, etc were listed in the encouraged category On November 6, the catalogue of industrial structure adjustment guidance (2019 version) (hereinafter referred to as the catalogue (2019 version)) was released The catalogue is composed of three categories: encouraged category, restricted category and eliminated category Specifically, it covers 8 encouraged categories, 6 restricted categories and 13 eliminated categories in the field of medicine The catalogue will be implemented from January 1, 2020 Among them, the encouragement category is mainly the technology, equipment, products and industries that play an important role in promoting economic and social development and are conducive to meeting the people's needs for a better life and promoting high-quality development In the category of pharmaceutical industry encouragement, new drugs, new technologies, traditional Chinese medicine and medical devices are included in a large number Hong Kong, Macao and Taiwan residents can participate in the Interim Measures for Hong Kong, Macao and Taiwan residents to participate in social insurance in the mainland (mainland) issued by the Ministry of social security, human resources and social security and the State Medical Security Bureau, which will come into effect on January 1, 2020 The measures include two categories of Hong Kong, Macao and Taiwan personnel employed in the mainland (mainland) and living in the mainland (mainland) without employment, and stipulate that Hong Kong, Macao and Taiwan residents employed in the mainland (mainland) shall participate in five basic social insurance Residents of Hong Kong, Macao and Taiwan who live in the mainland (mainland) but are not employed may participate in basic endowment insurance and medical insurance for urban and rural residents in their place of residence according to regulations Hong Kong, Macao and Taiwan residents participating in social insurance shall enjoy social insurance benefits according to law There are 35 articles in 7 chapters in the administrative measures for imported medicinal materials issued by the administrative measures for imported medicinal materials, regulating 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 responsibilities of imported medicinal materials that do not conform to the regulations 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 European Pharmacopoeia 10.0 published the tenth edition of European pharmacopoeia in July 2019, and 8 supplements will be updated in the next 3 years (10.1 to 10.8) The new and revised version of the tenth edition will enter into force on January 1, 2020 General technical requirements for production of monoclonal antibody products released on November 28, 2019, the national group information platform released the group standard of 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 The password law 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, so the issuance of password is of great significance According to the industry, the password used by general pharmaceutical enterprises is applicable to the scope of "commercial password" of the law Implementation of quality management standard for veterinary drug production According to the production process and characteristics of different types of veterinary drugs, five more detailed appendixes, including aseptic veterinary drugs, non aseptic veterinary drugs, veterinary biological products, APIs, and traditional Chinese medicine preparations, have been formulated in the "on veterinary drug production quality management specification (Revised Draft for comments)", which clearly defines the specific production quality management specifications of various types of products, with stronger guidance and operability This specification will 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 requirements of this specification before January 1, 2023