Medical network - August 17 in anhui, shaanxi, guangxi, sichuan, chongqing, Inner Mongolia and other more since her surgery of traditional Chinese medicine yinpian, recently, the Shanghai food and drug administration also released the Chinese medicine yinpian special inspection notice.
On August 15, the Shanghai food drug administration issued the implementation of the city's Chinese medicine yinpian enterprise special inspection notice, points out that between August 2017 and October will be carried out throughout the whole city during the traditional Chinese medicine yinpian enterprise special inspection.
According to the understanding, this special inspection will be divided into three phases, from mid-august to the end of August. From early September to late September for the central inspection phase; Late September - mid-october is the summary stage.
▍The problem of traditional Chinese medicine is frequently asked
According to statistics, in February this year so far, just six months, national food drug safety administration has 12 times the cumulative exposure of 375 Chinese medicine enterprises of 419 batches problems substandard Chinese medicine yinpian, origin of anhui, hebei, sichuan, guangxi, etc.
In recent years, the problem of Chinese traditional Chinese medicine has become more frequent, because the quality of Chinese medicine is influenced by many factors.
From the perspective of production and processing, the origin, harvest, processing, production environment and technical conditions will all influence the quality of Chinese traditional Chinese medicine.
In addition, the distribution and deployment of these two links will also affect the quality of traditional Chinese medicine.
And, more importantly, in recent years, frequent doping ShiJia further caused the Chinese medicine yinpian quality is unqualified, under the temptation of interests, unscrupulous vendors fraud system of method is varied: such as increased weight: soaking with Bai Tangshui dangshen to increase the weight; Variety chaos: use the fruits of the same plant turkmen wolfberry, northwest wolfberry, and Chinese wolfberry fruit instead of wolfberry fruit; Substitute for other varieties.
It is worth noting that there are also well-known enterprises in the enterprises named. The big names such as tongrentang, yunnan baiyao, Harbin pharmaceutical group and other major companies have all "recruited" and were asked to suspend sales use, recall products and make rectification by the state food and drug administration.
▍ attached: the Shanghai Chinese medicine yinpian enterprise special inspection
1. Scope of key inspection
(1) in the past two years, we have been involved in the wholesale (chain) and retail pharmacies of Chinese herbal medicine (TCM).
(2) in the past two years, complaints have been made to report on the quality of Chinese medicines for the quality of Chinese medicine, or the wholesale (chain) of drug stores and retail pharmacies that are not regulated;
(3) there are large wholesale drug distribution (chain) and retail pharmacy in this city.
(4) drug wholesaling (chain) and retail pharmacies that operate medical treatment of toxic drugs and medicinal poppy shells.
Ii. Key inspection contents
(1) no license to operate traditional Chinese medicine yinpian and the sale of counterfeit Chinese medicinal materials;
(2) the sales of traditional Chinese medicine prescription granules, toxic Chinese medicinal materials and traditional Chinese medicine tablets;
(3) processing and processing Chinese traditional Chinese medicine tablets and adulterated Chinese medicines in Chinese medicine, and there are activities such as packaging, changing labels and so on.
(4) buying and selling traditional Chinese medicine drinking tablets through illegal channels;
（5）From the outgoing yinpian production management enterprise to buy Chinese medicine yinpian is in line with the "Chinese pharmacopoeia", "Shanghai Chinese medicine yinpian concocted norms" and other legal standard, whether can provide real and sufficient evidence, and responsible for the quality of slices.
(6) toxic Chinese medicinal materials and Chinese medicines sliced and prepared for decoction not in strict accordance with the measures for the administration of the toxic drugs for medical use requirements of counters, and lock store safe-keeping, establish real and perfect records of purchasing and (zhang);
(7) not strictly follow the acceptance requirements of traditional Chinese medicines;
(8) there is no special library for Chinese medicinal materials and Chinese medicine.
(9) the storage and maintenance of traditional Chinese medicinal materials and the storage and maintenance of traditional Chinese medicines are not strictly required;
(10) not equipped with acceptance and maintenance personnel conforming to the relevant major of Chinese medicine;
(11) failure to regularly clean the fight according to the requirements, the situation of the wrong fighting and the series of fights, the existence of Chinese medicinal materials and traditional Chinese medicine in the case of raw insects, mildew, and deterioration (only applicable to retail pharmacies);
(12) there is no strict implementation of the relevant rules for the examination, deployment and verification of the prescription of traditional Chinese medicine tablets (for retail pharmacies only).
3. Check the division of labor
(1) city food drug administration YaoXie circulation supervision department to be responsible for the organization to carry out the special inspection, deployment of pharmaceutical wholesale (chain) enterprise self checking, for there are serious defects of pharmaceutical wholesale enterprises take drug GSP certificate in accordance with the law and make a public announcement.
(2) the municipal food and drug administration inspection office is responsible for the supervision of major cases, the execution of the execution, and the results of the investigation and investigation.
(3) Shanghai drug approval for verification center responsible for the implementation of drug wholesale (chain) enterprise special inspection of law enforcement team in check, the cumulative check enterprise not less than 20, one by one, issue the inspection conclusion, finish the examination and analysis, summary, report the work, rectification of illegal enterprise implementation tracking supervision.
(4) the law enforcement general team of the municipal food and drug administration is responsible for the sampling and inspection of the cases of illegal and illegal drug wholesalers.
(5) the district market supervision bureau is responsible for the jurisdiction special inspection of drug retail pharmacies, deploy enterprise self checking, and the accumulative total inspection enterprise should not be less than 20% of the total pharmaceutical trading enterprises within their respective jurisdictions, and is responsible for the product sampling inspection, to the problem of illegal enterprise case jurisdiction is investigated, the rectification implementation tracking supervision, for there are serious defects of drug retail pharmacies take drug GSP certificate in accordance with the law and make a public announcement.
Iv. Special inspection arrangements
From August 2017 to the end of October 2017, there are three stages:
First stage: organization self checking stage (mid August - at the end of August) : each unit according to the division of inspection organization Chinese medicine yinpian and business operation entities within its jurisdiction to carry out the inspection work earnestly, implement enterprise's main body responsibility, and requiring them to problems to develop corrective measures, forming self checking corrective report before the end of August (retail chain stores can be made of headquarters by stores district put into report, respectively).
The second stage: concentrated examination stages (early September - late September) : Shanghai drug approval for verification center according to the check point by flight check way to organize the implementation of special inspection of pharmaceutical wholesale enterprises;
The market supervision bureau shall carry out the special inspection of drug retail pharmacies in its jurisdiction according to the inspection priority. The enterprises that have illegal and illegal operation of traditional Chinese medicine yinpian behaviors shall be seriously investigated in accordance with the law. At the same time, the municipal administration of food and drug administration organized the general team and the drug review and verification center to carry out flight inspections throughout the city.
The third stage: the summary stage (late September to mid-october) should summarize the work experience of the special inspection, analyze the existing problems and explore the establishment of a long-term supervision system.
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