[Medicine heaven and earth] 19 provincial policies on conformity evaluation of generic drugs were sorted out, and 4 key points were collected; this week's drug regulatory storm, unqualified, discontinued, recalled

The local government has put forward a new policy 19 province generic drug consistency evaluation policy, which brings together the four key points of consistency evaluation has ushered in the final rush Whether to pass the consistency evaluation is very important for the development of many drug varieties and pharmaceutical enterprises Up to now, local governments have successively issued some policies on the purchase and pricing of generic drugs for consistency evaluation The small edition has been sorted out, as shown in the figure below The consistency evaluation policies issued by various provinces and cities all over the country involve the following points: to apply for consistency evaluation of drugs, build clinical trial platform, academic research platform, and provide technical support For the drugs applying for conformity evaluation, a green channel for evaluation and approval shall be established, and the qualification for evaluation shall be given priority For drugs passing the consistency evaluation, priority shall be given to purchase and use For drugs that pass the consistency evaluation, they will be selected into the medical insurance catalog first, and will be supported in medical insurance payment In addition, local governments have also adopted economic incentives for drugs that have passed the consistency evaluation Awards vary from province to province, ranging from 1 million to 4 million for a single variety At present, provinces with subsidy policies in the whole province include Sichuan, Gansu, Anhui, Fujian, Henan, Jiangxi, Beijing, Chongqing, Guizhou and Ningxia; cities with subsidy policies at prefecture level include Haikou, Chengdu, Bengbu, Fuyang, Guangzhou, Shaoxing, Bozhou, Xinxiang, Nanchang, Taizhou, Jinan, Weihai and Harbin Local drug related situation I spot check: 53 batches of drugs failed to meet the requirements of Hunan Provincial Food and Drug Administration on August 22, 2018, issue 4 drug quality announcement According to the announcement, 31 out of 423 batches of drugs completed in the province did not meet the standards Among them, there are 21 batches, 8 batches of traditional Chinese medicine and 2 batches of other drugs On September 3, Jiangxi Provincial Food and Drug Administration issued the 2018 drug quality announcement of Jiangxi Province (the 4th issue in 2018, 58 issues in total) According to the results of supervision and sampling inspection in this period, 1397 batches of 758 varieties meet the requirements of drug standards; 36 batches of 22 varieties do not meet the requirements of drug standards Second recall: 2603 bottles of Shenxiong glucose injection and 23 batches of Yinzhihuang soft capsule were recalled Guizhou food and Drug Administration issued the report on recall progress of Shenxiong Glucose Injection on September 7, which showed that as of September 3, Guizhou Jingfeng injection Co., Ltd had recalled 2603 bottles of Shenxiong Glucose Injection (GDZ h52020703 batch number: 201711130) On September 5, Guizhou food and Drug Administration issued the notice on ordering Guizhou Jinyu Pharmaceutical Co., Ltd to recall Yinzhihuang soft capsule According to the announcement, Guizhou Jinyu Pharmaceutical Co., Ltd revised the instructions of Yinzhihuang soft capsule in September 2017 in accordance with the requirements of the announcement, but did not replace the instructions of the drug produced before the filing As a result, Yinzhihuang soft capsule (approval No.: gyzz z20050602) produced by the company that failed to mark the updated content of the instruction manual as required is still found on the market In order to ensure the safety of public medication, the authority ordered Jinyu pharmaceutical to recall Yinzhihuang soft capsule (23 batches, 720 pieces in total) that failed to mark the updated content of the instruction manual as required within the validity period before September 30, 2018 , report the recall to Guizhou food and Drug Administration on time and publicize it to the public 3 Suspension of sales: on September 7, the State Food and Drug Administration issued the announcement on suspension of sales and use of quetiapine fumarate of Dr redI laboratory Co., Ltd According to its introduction, quetiapine fumarate (English Name: quetiapine) was found in the field inspection of overseas production of drugs organized by the former State Administration of drug administration on Dr Reddy's laboratories Ltd of India Fumarate; Registration Certificate No of imported drugs: h20160462) the current production process, production site and batch are inconsistent with the content of registration and approval, which does not meet the requirements of China's pharmaceutical production quality management specification (revised in 2010) In order to ensure the drug safety of the public, it is decided to suspend the sale and use of the product in China and deal with it according to law The port food and drug administration shall suspend the issuance of import clearance certificates for the products The mirtazapine tablets of the dynamic one Harbin Sanlian of local pharmaceutical enterprises passed the first consistency evaluation, and the third Harbin Sanlian issued a notice on September 9, saying that it received the approval document for supplementary application of mirtazapine tablets (15mg) approved and issued by the State Food and drug administration, and the product passed the consistency evaluation of quality and efficacy of generic drugs Mirtazapine tablets are used in the treatment of depression Up to now, the company is the first enterprise in China to pass the consistency evaluation of mirtazapine tablets (15mg) Erjingfeng pharmaceutical subsidiary obtained the GMP certificate, Jingfeng pharmaceutical issued a notice on September 7, saying that its subsidiary Guizhou Jingcheng recently received the GMP certificate issued by Guizhou food and drug administration, which is valid until September 5, 2023 According to the announcement, the tincture production line that has passed GMP certification is "Zhentong Huoluo tincture", with an annual design capacity of 3 million bottles And the line is a new line, which is the first certification Because it is in the same line with Guizhou jingchengyuan aerosol production line, no new large amount of capital investment has taken place Another heavyweight product of sanhengrui was approved to produce Hengrui medicine on September 6, which announced that it had received the drug registration approval document on paclitaxel for injection (albumin binding type) approved and issued by the State Food and drug administration Paclitaxel for injection (albumin binding type) is an anti microtubule drug, which is used to treat metastatic breast cancer or breast cancer relapsed within 6 months after adjuvant chemotherapy Four days force joined hands with arbor company of the United States and innovated compound Chinese medicine to go abroad On September 6, Tianshili announced that it signed a cooperation agreement with arbor company of the United States pharmaceutical company According to the agreement, Tianshili party received a maximum of US $23 million of clinical R & D investment from arbor company to jointly carry out the clinical development and research of Compound Danshen Dropping Pills (US FDA clinical research application code: T89) in the US At the same time, the exclusive right to sell T89's relevant indications under the agreement in the U.S shall be paid to arbor company After T89 is approved by FDA for listing, Rexroth can obtain a sales milestone payment of up to $50 million and a sales profit sharing of up to 50% The performance of the five pharmaceutical industries continued to decline, with net profit in the first half of the year down 97.16% year on year, and the pharmaceutical industry released the semi annual report on September 4 According to the annual report, in the first half of the year, Dali pharmaceutical achieved a revenue of 203 million yuan, an increase of 56.04% over the same period of last year; its net profit was 885800 yuan, a decrease of 30.2849 million yuan over the same period of last year, a sharp decrease of 97.16% The company's explanation for the decline of net profit in the first half of 2018 is that the sales volume of the leading products in the scope of medical insurance payment is greatly reduced due to the double restrictions of medical institution level and indications, which leads to the decline of the company's operating performance Information source: yaozhi.com, Yilian zhaocai.com, sepilan.com, bureau of health and knowledge, local medical station, medical mobile newspaper, China net finance and other statements: this point of view only represents the author, not the position of yaozhi.com, welcome to exchange and supplement in the message area; if you need to reprint, please note the author and source of the article.