Policy part of medical event in October: more clear objectives of pharmaceutical enterprises

[pharmaceutical network industry trends] since October, the relevant policies of China's pharmaceutical industry have been issued continuously, which has a certain impact on pharmaceutical enterprises In particular, after the release of the catalogue of batch encouraged generic drugs, the development of high-quality generic drugs will be encouraged, which can effectively reduce the cost of drug use for patients, and can also intensify the production of relevant enterprises, improve the quality of drugs, and benefit more patients Opinions on further ensuring the supply and price of drugs in short supply was published in October this year, China issued opinions on further ensuring the supply and price of drugs in short supply, requiring measures to be taken from the aspects of drug purchase, use, storage and price supervision to promote the supply and price stabilization of drugs in short supply The issue of this opinion may be expected to effectively curb the drug shortage Release of catalogue of drugs to be approved and imitated On October 9, the national health and Health Commission issued the catalogue of approved and encouraged generic drugs, 33 varieties of which were selected, including breast cancer treatment drugs isapirone, fluvectin, anti HIV drugs abacavir, anti malaria drugs atorvastatin, mercaptopurine for children with leukemia, methotrexate for rheumatoid arthritis and other cheap drugs in short supply, as well as children Drugs, drugs for rare diseases, etc The DRG reform came in October, the National Medical Security Bureau issued the notice on printing and distributing the technical specifications and grouping schemes of DRG payment pilot countries, which contains two important standards, namely, the technical specifications for DRG grouping and payment of national medical security and the grouping scheme of national medical security DRG (chs-drg) At the same time, it is pointed out that the top-level design will be completed by the medical insurance bureau in 2019, the national pilot cities will be simulated in 2020, and the DRG will be put into practice in 2021 The revision of the instruction manual of Danshen and ligustrazine injection was announced by the State Food and Drug Administration recently It was decided to revise the instruction manual of Danshen and ligustrazine injection, requiring to add the warning words "this product may cause serious allergic reaction (including anaphylactic shock)", and to add a number of adverse reactions, taboos and precautions On October 23, the State Food and Drug Administration issued a circular on the non conformity of 83 batches of drugs According to the inspection of 9 drug inspection institutions including Nanjing food and drug administration, 83 batches of drugs marked as 68 enterprises did not meet the requirements For the above-mentioned non-conforming drugs, the drug regulatory department has required relevant enterprises and units to take risk control measures such as suspension of sales and use, recall, etc., to investigate the causes of non-conforming drugs and carry out effective rectification On October 22, the State Food and Drug Administration issued the notice of four guiding principles of registration technology review, including aspartate aminotransferase test reagent According to the notice, in order to strengthen the supervision and guidance of the registration of medical devices and further improve the quality of registration and examination, the State Drug Administration has organized the formulation of the guiding principles for the technical review of registration of aspartate aminotransferase assay reagents, the guiding principles for the technical review of registration of total cholesterol assay reagents, the guiding principles for the technical review of registration of uric acid assay reagents, and The guidelines for the technical examination of the registration of urea testing reagents are hereby promulgated Announcement on protected varieties of traditional Chinese Medicine On October 9, the State Food and Drug Administration issued a notice on the protected varieties of traditional Chinese medicine According to Article 16 of the regulations on the protection of varieties of traditional Chinese medicine and relevant provisions, two protected varieties of traditional Chinese medicine, including Tiandan Tongluo capsule produced by Shandong Fenghuang Pharmaceutical Co., Ltd and Shengxuening tablet produced by Wuhan United Pharmaceutical Co., Ltd., were continuously protected at level 2 after review and approval 13 drug approval numbers were cancelled On October 9, the State Food and Drug Administration announced that according to relevant regulations, the State Food and Drug Administration decided to cancel 13 drug approval numbers, including alendronate sodium tablets.