Medical network on April 13 - recently, jiangxi food drug safety release "jiangxi medicine circulation supervision priorities for 2017" (hereinafter referred to as "points"). 

 

Learned, bureau of jiangxi province in 2017 will be arranged flight check 60 times, with cold-chain drugs, such as hemp compound preparations containing special control drugs and have bad behavior records and reports, complaints and drug safety risk hidden trouble of pharmaceutical wholesale enterprises as the key point, by the provincial drug certification center set up the annual work plan and specific implementation. 

 

It is important to note that after B certificate, C certificate of approval, jiangxi food drug administration in "points", put forward to explore to solve the problem of the follow-up supervision and the cancellation of drug approval online trading. 

 

The following is the key point of the main content: 

 

Source defend and strict market access 

 

1, to grasp the development trend of the current medicine circulation, according to the state administration of GSP and the new condition of starting a business should have modern logistics requirements, such as strengthen the drug business license management, strict standards, strict inspection, strict access. Strengthening guidance, encourage modern logistics enterprises, to increase the rate of retail chain enterprises, improve concentration. 

 

2, locked good pre-approval for the record, carrying out the new revised "advertisement law", from the source standard pharmaceutical advertising and the Internet drug information release, safeguard legitimate rights and interests of consumers. 

 

Process to implement precise regulation 

 

3, a solid routine supervision. Around to accurately grasp the new situation of regulatory requirements, strengthen risk screening, on May cause the risk of drug quality event to take decisive measures to strive to eliminate systemic, regional risk, trying to "run" in front of the risk regulatory work. In the implementation of full coverage at the same time, according to the situation of enterprise scale, management level, violation and operating risks, determine the intensity of supervision and inspection, obey the safety line. In accordance with the principle of a card a, establish and improve the pharmaceutical trading enterprises supervision archives, do not miss. Explore establishing daily regulation "buckle system method, ensure the regulation to obtain actual effect. 

 

4, adhere to the problem oriented, in accordance with the principle of "two random a public" to carry out the flight check, the implementation of "precise regulation", intensify punishment to illegal enterprise, reversed transmission enterprise to carry out the principal responsibility. 

 

ShengJu arrange flight check 60 times in 2017, with cold-chain drugs, such as hemp compound preparations containing special control drugs and have bad behavior records and reports, complaints and drug safety risk hidden trouble of pharmaceutical wholesale enterprises as the key point, by the provincial drug certification center set up the annual work plan and specific implementation. 

 

Around to check daily supervision and tracking, etc as a whole regulatory means, determine fly inspection proportion, flying inspection plan to quote ShengJu, examination and treatment in newspaper ShengJu must at the same time to the public in a timely manner. 

 

5, focus public attention of pharmaceutical advertising and the Internet information release hot issues, such as strengthening monitoring, timely notice of illegal advertisement and information, timely treatment, crack down, suspend its sales of serious illegal advertising. Around to carry out the drug Internet information service enterprises within their respective jurisdictions of online monitoring, when it is necessary to carry out spot checks. Explore to solve the problem of the follow-up supervision the cancel the drug approval online trading. 

 

Risk control and regulation problems 

 

6, with the implementation of the policy of "two votes", based on the special medicine circulation in 2016, continued to pharmaceutical wholesale link to carry out the renovation, the key to crack down on unlicensed operation and attached ticket, goods zhang ticket does not agree, not timely issue (for) invoices, statistics, and corporate personnel especially such outstanding problems as salesman chaos, consolidate and expand the rectification of the effect. 

 

7, according to the current situation of the integration of urban and rural areas and rural areas such as weak regulation, continue to carry out the integration of urban and rural areas and rural areas small pharmacies, clinics and drug quality rectification, standardize purchase channels, strengthening quality consciousness, a crackdown on sales JiaLie and illegal recycling drug behavior, ensure the basic safety of the people. 

 

8, strengthening involves the drugstore that decide a dot of the supervision of the people's livelihood, according to the province people club hall and ShengJu jointly issued "on further and the management of medical insurance fixed-point retail pharmacy service notice (jiangxi club word [2012] no. 219) division of duties, focusing on retail pharmacy drug purchasing channels are legal," marketing "process is in compliance with the GSP requirements specification, tickets, account, the goods are consistent, drugs and actual sales sales vouchers are consistent, whether pharmaceutical technical personnel on-the-job, etc. 

 

9, the camphor trees continue to traditional Chinese medicinal materials, professional market and its surrounding regulation of proper implementation of Chinese herbal medicine market the special plan, keep high pressure situation, to crack down on producing JiaLie Chinese medicine yinpian violation behavior, such as traditional Chinese medicine. Around the business enterprises, medical institutions, and other units should be tightened regulation of Chinese herbal medicine, Chinese medicine yinpian marketing channels, and found that unknown to resolutely combat. 

 

10, strengthen supervision on high-risk varieties. Key check the CDC vaccine, vaccination units, commissioned distribution enterprise under refrigerated conditions prescribed by the vaccine storage, transportation, vaccine procurement channels are legal. Of hemp compound preparations, drug review the legality of marketing channels, termination of pregnancy to the purchase and sale quantity and flow to the exception to be traced back, punishing the illegal behavior. Of blood products, biological products, and other key chain drug inspection, warehousing transportation condition, temperature and humidity monitoring system, and validation, etc., on the cold chain is not eligible to cancel its business scope, no hidden dangers.