This April is also a month of frequent policy, such as "Opinions on reforming and improving the supply and use policies of generic drugs", the third batch of catalogues for the evaluation of generic drugs through conformity evaluation, the release of zero tariffs for imported drugs, and the import of chemical drugs. And the preparations are no longer mandatory inspection by batch, adjustment of anti-cancer drug value-added tax and so on. Today, we will bring you a review of the policy articles of the April medical event. (Pharmaceutical product image source: China Pharmaceutical Network) "Opinions on Reforming and Perfecting the Supply and Guarantee Policy of Generic Drugs" On April 3, the state issued the "Opinions on Reforming and Improving the Policy of Supply and Use of Generic Drugs" (hereinafter referred to as "Opinions"). The Opinions aim to promote the research and development of generic drugs, improve the quality and efficacy of generic drugs, improve the ability of drug supply, better meet the needs of clinical drugs and public health, and accelerate the leap from a large pharmaceutical country to a pharmaceutical power. Specifically, there are mainly the following points, including the development of a list of drugs that encourage imitation, the strengthening of generic drug technology, the improvement of intellectual property rights protection, the acceleration of the evaluation of the quality and efficacy of generic drugs, and the improvement of pharmaceutical raw materials and packaging. Material quality, improving process manufacturing level, strict drug review and approval, strengthening drug quality supervision, timely inclusion in procurement catalogue, promoting the substitution of generic drugs, exerting the incentive effect of basic medical insurance, clarifying the compulsory licensing path for drug patents, and implementing tax incentives And price policy, promote the internationalization of the generic drug industry, and do a good job in propaganda and guidance. "Large medical equipment configuration license management catalog (2018)" released On April 9th, the notice of the "Large Medical Device Configuration License Management Catalogue (2018)" was released, and the management items of the new version of Class A and Class B large-scale medical equipment were officially released. The author has learned that the 2005 version of the catalog has been used before the 2018 catalog. The 2018 version has undergone significant changes compared to the 2005 version of the catalog. For example, under the 2018 catalogue, the coverage of Class A large equipment has been greatly reduced, leaving only PET-MR, high-end and ultra-high-end radiotherapy equipment, and the threshold for entry has been greatly improved, raising it to 30 million yuan. The coverage of Class B large equipment has also increased greatly, mainly from the transfer of Class A equipment, and the threshold for Class B entry has been raised to 10 million yuan. The third batch was released through the catalogue of generic drug conformity evaluation On April 13, the State Drug Administration issued the third batch of announcements on the consistency evaluation of generic drugs. According to the announcement, there are 6 varieties of amoxicillin capsules, azithromycin tablets, clopidogrel hydrogen sulfate tablets, enalapril maleate tablets, enalapril maleate tablets and irbesartan hydrochlorothiazide tablets. Specifications are evaluated through generic consistency. "Ancient classics catalogue (first batch)" was born On April 16, the State Administration of Traditional Chinese Medicine issued the "Ancient Classics List (First Batch)". It is reported that the first batch contains 100 prescriptions, including the number, name, original (source, prescription, recipe and usage), dosage form, etc., showing the basic information and original knowledge value of the prescriptions recorded in ancient books. On April 19th, the "Technical Guiding Principles for the Revision of the Regulations for the Processing of Provincial Chinese Herbal Pieces" (hereinafter referred to as "the Principles") was issued. The "Principles" requires that the provincial-level Chinese medicine decoction pieces should be revised in accordance with the theoretical guidance of Chinese medicine. To revise, we must adhere to scientific research and technological innovation while inheriting and protecting local characteristics. 28 drugs cancel import tariffs On April 23, an announcement was issued on the reduction of import tariffs on pharmaceuticals. According to the announcement, the import tariffs on all common drugs including anticancer drugs, alkaloid drugs with anticancer effects, and Chinese patent medicines with actual imports will be reduced to zero by a provisional tax rate. A total of 28 drugs, including anticancer drugs, have eliminated import tariffs. Currently, this policy has been formally implemented. Imported chemical raw materials and preparations are no longer mandatory inspection by batch On April 26, the announcement on matters related to customs clearance inspection of imported chemicals was released. The announcement showed that imported chemical raw materials and preparations (excluding chemicals sold in China for the first time) were not compulsory for inspection at the time of import. This policy will ease the burden of drugs for patients, especially cancer patients, and patients will have more medication options in the future. Public Consultation on "Implementation Measures for Drug Testing Data Protection (Provisional)" On April 26, the “Implementation Measures for the Protection of Pharmaceutical Test Data (Provisional)†(hereinafter referred to as the “Measuresâ€) was open for public comment. The Measures stipulate that during the period of protection, without the consent of the data protection right holder, the State Drug Administration shall not approve other applicants for the same type of drug listing application, but the applicant relies on the self-acquired test data or the applicant who obtained the marketing permission. Except for consent. Anti-cancer drug VAT adjustment minus 3% of import value-added tax On April 27, the anti-cancer drug VAT adjustment announcement was released. According to the announcement, VAT general taxpayers produce and sell, wholesale and retail anti-cancer drugs, and can choose to pay VAT according to the 3% rate according to the simple method. The taxpayer mentioned above shall not change the tax within 36 months after selecting the simple method to calculate the value-added tax. Collapsible Foot Spa,Foot Spa Bath Massager,Foot Bath Spa Massager,Foot Soak Tub Huaian Mimir Electric Appliance Co., LTD , https://www.mimirfootbath.com
"Technical Guidelines for the Revision of the Regulations for the Processing of Provincial Chinese Herbal Pieces"