[Medicine heaven and earth] the national pharmacopoeia committee "shouted" CDE, in response, the restrictions on non basic drugs have been released; the medical insurance bureau points to the "two vote system" and does not refuse to pay loans

Hot news focuses on whether the national pharmacopoeia committee has set the national standard "shout" CDE for drugs Recently, Huabei pharmaceutical applied for the conformity evaluation of amoxicillin capsule generic drugs The dissolution of its quality standard was in accordance with USP, but it did not meet CP the drug evaluation center (CDE) of the state drug administration asked the enterprise to discuss with the National Pharmacopoeia Committee (CHP) to revise the national standard of the product The CHP Committee then sent CDE on its official website on this issue After that, the State Pharmacopoeia Committee published the reply letter, which caused insiders to think that "CDE and the Pharmacopoeia Committee kick the ball"? The reply clearly stated that the national standard of the variety would not be revised until it was approved by CDE At the same time, relevant media revealed that the response letter of the relevant person in charge of the State Pharmacopoeia Commission to the public was to make enterprises and drug research and development institutions more clearly understand the procedures of the revision of national standards, not a "wrangle" between the two business departments of the drug administration In 2019, speeding up the pace of TCM treatment has always been the focus of drug sampling, and it is also the product with the highest frequency among unqualified drugs Although in recent years, the state has issued various policies to strengthen the processing technology of Chinese herbal pieces, improve their quality, and strengthen sampling and rectification efforts However, according to the notice on unqualified drugs issued by each province in 2018, the number of unqualified batches of traditional Chinese medicine accounts for more than half of the total According to the database of quality non conformity announcements of smart drugs, in 2018, 3965 batches were released nationwide, down 25.82% year on year Among them, the annual unqualified rate of traditional Chinese medicine preparation (according to the statistics of traditional Chinese medicine and traditional Chinese Medicine) accounts for 93.52% According to the notice issued by provinces and cities every month, the quality problem of traditional Chinese medicine is the most prominent The following is the sampling details of unqualified Chinese herbal medicines from January to December 2018 Since the beginning of last year, the provinces have launched the centralized management of the quality of traditional Chinese medicine More than 10 provinces, including Shandong, Henan, Gansu, Guangxi, Jiangxi, Heilongjiang, Anhui, Sichuan, Hainan, Jiangsu, etc., have carried out the rectification of Chinese herbal pieces, including the four distribution centers of Chinese herbal medicines - Bozhou in Anhui, Anguo in Hebei, Zhangshu in Jiangxi and Yuzhou in Henan, which are also the key sampling objects The following is the batch number of substandard Chinese herbal medicines announced by the State Food and Drug Administration and provinces in 2018 As can be seen from the above figure, the hardest hit areas of quality problems of traditional Chinese medicine are Shandong, Jiangxi, Liaoning and Yunnan With the strengthening of sampling inspection and the increasing frequency of sampling inspection, the number of unqualified batches may rise month by month I remember that on August 31 last year, the State Food and Drug Administration issued the work plan for the centralized treatment of the quality of Chinese herbal pieces The notice pointed out that from October 2018 to September 2019, the treatment began, and the illegal behaviors were resolutely investigated and dealt with The summary of the treatment work must be completed before the end of October 2019 Presumably this year, the pace of TCM treatment will be correspondingly accelerated Fujian Province: do not implement the "two vote system", medical insurance bureau refused to pay! Recently, Fujian Medical Insurance Bureau, in conjunction with the provincial health and Health Commission, issued a notice, which stressed that medical insurance administrations at all levels should strengthen the supervision and inspection of the "two vote system" Public medical institutions and enterprises designated by the medical insurance that failed to implement the provisions, in accordance with the notice on further cracking down on fraudulent medical insurance funds and violations of patients' rights and interests (min medical insurance office [2016] No 8) and other relevant provisions Handle According to the requirements of No 8 document, "do not implement the two ticket system of consumables" will be included in the "blacklist" of Fujian Province's medical security system, and relevant enterprises will be directly disqualified from the province's online distribution qualification, and the medical insurance fund will refuse to pay for goods! It is reported that as early as January 2017, Fujian Province made it clear to implement the "two ticket system" for consumables, but it is the first time to conduct a comprehensive inspection on the implementation! And this time, the medical insurance bureau at all levels is responsible for the leadership! In order to ensure the good quality of the policy, the medical insurance bureau, which has the absolute say in the payment method of medical insurance, will gradually strengthen the supervision of the circulation of drugs, medical devices and other aspects, and the wind of "sales with money" will be hit hard Shandong implements the new version of the basic medicine catalogue, and the restrictions on non basic medicine varieties have been released! Recently, Shandong provincial health and Health Commission issued the notice on the implementation of the national essential drug catalog (2018 version) (hereinafter referred to as the notice), and announced a series of detailed measures for the implementation of the new version of the basic drug catalog In principle, the proportion of basic drugs purchased by basic medical and health institutions in the total amount of drug procurement should be controlled above the original level, that is, the proportion of basic drugs purchased by basic medical and health institutions in the total amount of drug procurement should be more than 30% It can be seen that in order to respond to national policies, Shandong Province has also relaxed the restrictions on non base drugs on the premise of ensuring the market of basic drugs As we all know, in 2018, the new version of the list of basic drugs is "advanced basic drugs, then medical insurance", and relevant policies indicate that it is preferred to be included in medical insurance rather than compulsory That is to say, if new varieties want to enter the medical insurance, they cannot escape the "price reduction" Moreover, with the reform of bidding and purchase (price for quantity) and the increase in the proportion of medical institutions using non base drug catalog, the advantages of the new base drug catalog are not the same as before Therefore, compared with Shandong Province, will other provinces take the same measures to re regulate the use proportion of base drug catalog and non base drug catalog? Hubei health and Health Commission requires all public hospitals to pay off their debts by the end of June 2019 Recently, Hubei health and Health Commission issued the notice of "special cleaning work plan for arrears of private enterprises of public hospitals in Hubei Province" According to the announcement, all public hospitals are required to work out a classified resolution plan based on a comprehensive understanding of the amount of arrears, the time beyond the contract and the reasons for the arrears, and pay off the arrears before the end of June 2019 At the same time, we should establish and improve the effective mechanism of timely performance payment to prevent new arrears Industry sources said that compared with the "notice on Further Strengthening the management of drug payment collection in public medical institutions" issued earlier by the health and Family Planning Commission of Hubei Province The announcement specifies the specific time of debt clearing, namely, the inventory stage (before the end of January 2019), the priority debt clearing stage (before the end of March 2019) and the comprehensive debt clearing stage (from April to June 2019), so its enforceability is higher, which is good news for private pharmaceutical commercial enterprises Information source: State Pharmacopoeia Commission, tongyouyi, bureau of health and information, pharmaceutical cloud studio and other statements: this point of view only represents the author, not the position of yaozhiwang, welcome to exchange and supplement in the message area; if you need to reprint, please be sure to indicate the author and source of the article.