The State Food and Drug Administration will take the initiative and the traditional Chinese medicine will face the great rectification

Source: Cypress blue 2018-4-28 traditional Chinese medicine industry, about to usher in a major rectification! On April 26, Jiao Hong, director of the State Food and drug administration, presided over the "Symposium on the supervision of Chinese Herbal Pieces", listened to the opinions and suggestions of academicians in the field of traditional Chinese medicine, experts in the field of clinical scientific research of traditional Chinese medicine, manufacturers of Chinese Herbal Pieces, professional markets of Chinese herbal medicine, and principals of industry associations and societies, focused on Problems and examined the quality management of Chinese herbal pieces It can be seen that at the beginning of the establishment of the State Food and drug administration, the quality of Chinese herbal pieces has been targeted At the meeting, Jiao Hong, director of the State Food and drug administration, pointed out that the supervision of decoction pieces of traditional Chinese medicine should be based on the existing laws of traditional Chinese medicine, emphasizing the standardization, applicability and scientificity of management The supervision of Chinese herbal pieces is bound to involve upstream and downstream industries, which requires the concerted efforts of all parties to form a common push mechanism By strengthening the management of Chinese herbal pieces, we can promote the establishment and strengthening of the whole industry chain management mode of Chinese herbal medicine Drug regulatory authorities actively listen to experts and industry suggestions, improve the long-term regulatory mechanism, and promote the healthy development of the industry Chinese herbal pieces are the core link of Chinese medicine industry The rectification of Chinese herbal pieces is the rectification of Chinese medicine industry This means that starting from Chinese herbal pieces, from upstream to Chinese herbal medicine, from downstream to Chinese patent medicine, the whole Chinese herbal medicine industry will face more strict supervision Experts at the meeting believe that at present, the quality level of Chinese herbal pieces is still not optimistic There are some problems in the quality management of Chinese herbal pieces, such as the inadequate implementation of the main responsibility of enterprises, the nonstandard cultivation of upstream Chinese herbal medicines, the non traceability of the circulation of herbal medicines, and the unsound quality standards The representatives at the meeting made suggestions, starting from the source of traditional Chinese medicine, urging the enterprises to fulfill their main responsibilities; standardizing the initial processing of the origin; establishing the circulation and traceability system of traditional Chinese medicine; strengthening the quality control of traditional Chinese medicine; paying attention to the quality management of the use of pieces of Chinese medicine; continuing to improve the pharmacopoeia standard; establishing the record management system of pieces of Chinese medicine; severely cracking down on violations of laws and regulations, etc In fact, in the strict monitoring of the work of Chinese herbal pieces, all over the country has been increasing strength and intensity Recently, many food and drug administrations in many provinces issued announcements related to Chinese herbal pieces Zhejiang: on April 26, three pharmaceutical enterprises were flying tested, and the Zhejiang food and Drug Administration issued the notice on flight inspection and handling of drug circulation in Zhejiang Province (No 1 in 2018) According to the announcement, 3 enterprises were found to have problems in the flying inspection of Chinese herbal pieces, and were required to rectify The specific problems are as follows: 1 The scale and conditions of some warehouses of Taizhou Shangyao Pharmaceutical Co., Ltd can not meet the reasonable and safe storage of drugs 2 After the temperature of the refrigerator car exceeds the standard, the recording interval does not meet the requirements 3 The input and modification of some data in the computer system are not standardized 4 The enterprise fails to store individual drugs according to the temperature requirements of the drug packaging 5 There are cracks and pits on the ground of the patent medicine cool storage 6 The company failed to open the box for acceptance of individual drugs according to the specified proportion 7 After unpacking (nylon bag) of Chinese Herbal Pieces for acceptance, there is no seal or acceptance mark 8 During the maintenance, no damage was found on the outer package of some stored drugs Jiaxing boyada Pharmaceutical Co., Ltd 2 The drafting, revision, review and approval of quality management system documents are not standardized 3 Centipede (XX pharmaceutical, Zhejiang, 20161219) has been seriously mildewed, visible to the naked eye, and is still placed in the qualified product area, and no relevant measures have been taken to stop the sale 4 Some of the sales receipts of compound preparations containing special drugs do not conform to the filing signature, for example, Taino tablets (Shanghai Johnson & Johnson pharmaceutical, batch number 171126) sold to the clinic of detention center of XX Municipal Public Security Bureau on February 2, 2018 5 The staff training carried out by the enterprise is insufficient 6 The enterprise failed to review and revise the documents according to the changes of national laws and regulations, such as the standard of sulfur dioxide residue not specified in the acceptance system of Chinese herbal pieces, and the management system of electronic supervision code not revised 7 The partial unpacked medicines were not stored in a centralized way Zhejiang Santong Pharmaceutical Co., Ltd Ask Qi, the inspector of traditional Chinese medicine, about the acceptance of traditional Chinese medicine on the spot, but they can't answer correctly 2 Failed to carry out batch by batch acceptance of Chinese herbal pieces and check the inspection report 3 There is no record for the treatment of some unqualified drugs 4 There are medicines that need to be stored in a cool place in the normal temperature waiting area Gansu: 27 batches of Chinese herbal pieces were unqualified on April 26, the food and Drug Administration of Gansu Province reported the results of targeted supervision and sampling of Chinese herbal pieces that failed to meet the requirements in previous years, were adulterated and easy to dye, gain weight, and were fumigated with sulfur in the whole province 27 batches of Chinese herbal pieces were unqualified in this sampling For the unqualified Chinese herbal pieces found in the sampling inspection, the relevant food and drug supervision and administration departments have taken control measures such as sealing up and detaining, requiring the sampled units to suspend the sale and use of the unqualified products and make rectification The situation of unqualified products is as follows: Sichuan: Recently, Sichuan food and Drug Administration issued a notice on centralized quality control of Chinese herbal pieces Since mid April, Sichuan Province has carried out centralized quality and safety control of Chinese herbal pieces throughout the province The focus of this renovation is the production and circulation of Chinese herbal pieces It is understood that the period from mid April to mid May is the stage of enterprise self-examination, and the production and wholesale enterprises of Chinese herbal pieces within their respective jurisdictions are organized to conduct self-examination on the production, purchase and sales of Chinese herbal pieces since January 1, 2017, and formulate rectification measures for the existing problems From late May to late June is the stage of inspection and supervision The enterprise information that fails to submit the rectification report or refuses to report on time shall be made public to the public and listed as the key objects of inspection and supervision If any illegal act is found, it shall be severely punished The focus of this production link renovation is: 1 The enterprises that have been inspected by the State Administration or provincial administration in the past two years due to unqualified Chinese Herbal Pieces announced by the food and drug regulatory authorities at all levels in the spot check since 2017, illegal production behaviors found in the daily supervision; 2 In the production process, dyeing and weight increase, doping make fake; in the production of Chinese Herbal Pieces in the unauthorized site, purchasing intermediate products or finished products of Chinese Herbal Pieces for sub packaging, changing the packaging label; 3 Purchased Chinese herbal medicine and ex factory Chinese herbal pieces are not inspected according to the legal standards; batch production records and batch inspection records are incomplete, and the data is not true The key points of circulation are: 1 Purchase and sale of Chinese herbal pieces from illegal channels; 2 Purchase and sale of fake and inferior Chinese herbal pieces; 3 Illegally repackage Chinese herbal pieces; 4 Purchase and sale of Chinese herbal pieces without asking for or issuing invoices (including the list of taxable services) and the accompanying bills, or although there are invoices and other bills, but the relevant information (unit, product name, specification, batch number, amount, payment direction, etc.) is inconsistent with the actual situation; 5 The Chinese herbal pieces are not stored and maintained as required Is there any problem with the quality of the pieces in most of China? In recent years, Chinese herbal pieces have become frequent customers in the list of unqualified drugs in the country and provinces, some even the whole list is Chinese herbal pieces Among these unqualified pieces of traditional Chinese medicine, there are many varieties from some famous large enterprises According to the 2017 annual analysis report on unqualified drug quality data, 80% of the unqualified drugs in 2017 were traditional Chinese medicine It is reported that the unqualified drugs are mainly Chinese herbal medicines and Chinese patent medicines under the category of traditional Chinese medicine, accounting for 86% Statistics show that the number of unqualified Chinese herbal medicines is particularly prominent, accounting for 64% of the total number of unqualified drugs, and the proportion of Chinese Herbal Pieces enterprises is also greatly increased compared with 2016 In fact, it should be said that it is difficult to find qualified Chinese Herbal Pieces in the detection From the general situation of many announcements, the unqualified items of Chinese herbal pieces are no longer only dyeing weight gain and fake drugs, but more of a certain variety and a certain component index are unqualified, even the character (piece type) is unqualified It can be seen that at present, the regulatory mode of traditional Chinese medicine industry is changing rapidly, and the requirements are more and more strict Prior to this, Dou Qiling, chairman of Yibai pharmaceutical, once told the media that the current Pharmacopoeia's test standard for Chinese herbal pieces is completely in accordance with the chemical composition and content of Western medicine as the quality standard, and the standard is very strict, resulting in the majority of Chinese herbal medicine testing unqualified According to this, Chinese herbal medicine will gradually shrink Traditional Chinese medicine is the treasure of the Chinese nation, and "healthy China" is inseparable from the development of traditional Chinese medicine It can be predicted that under the leadership of the State Food and drug administration, the supervision and control of the quality of traditional Chinese medicine will be more and more strict in the future The traditional Chinese medicine industry, after undergoing a great reorganization and shuffling, will usher in another new life.