& ldquo; Newly revised drug GSP officially introduced，On the one hand, the Stake Sports BettingElectronic supervision code completely exit the GSP system，On the other side is the emphasis on the establishment of the traceability system，Take the enterprise as the main body of the responsibility system，In the future, it may take more expensive costs to build this system。& rdquo;

 

  July 20，The State Food and Drug Administration (hereinafter referred to as & ldquo; cfda & rdquo;) announced the "Decision on Modifying & LT; Drug Operation Quality Management & GT; State Administration of Food and Drug Administration No. 28)，and implement it from the date of announcement。"Specifications for the Management Quality Management of Drugs" (hereinafter referred to as & ldquo; gsp & rdquo;)，Reopen。

 

  E pharmaceutical managers will sort out the modification of GSP according to CFDA，A total of 16 modifications are made this time，Among them, 4 delete 4，Add 1 to，Modify 11 items。

 

  The newly modified drug GSP is compared with the GSP revised version released on June 15, 2015，Drug Electronics Supervision Code completely exit the historical stage of GSP management，Let the previously quoted & ldquo; drug Stake Sports BettingElectronic supervision system was stopped & rdquo; dust settled。With the pharmaceutical electronic supervision code, it was used as a drug production、circulation、Supervision methods for the entire process of sales are canceled，GSP strengthens the expression of the pharmaceutical traceability system。and on the other side，New revised GSP emphasizes the construction of traceable system everywhere，Enterprise will be the responsible subject of the traceable system，In the future, we still need to invest huge sums of money to create a system。

 

  GSP is the management specification of medical business enterprises，engaged in drug circulation、Sales companies must pass GSP certification。and this break one，Formally determined through the GSP industry management specifications，Need to study it。

 

  1, no drug regulatory code since then

 

  From January 1, 2016，Stake Sports BettingElectronic supervision drugs from stake sports betting appspecial medicines、Basic drugs are extended to all medicines，The scope of supervision has expanded from production enterprises to pharmaceutical retail enterprises，and according to CFDA requirements，All drug business enterprises that have not reached the newly modified pharmaceutical GSP standard，All stop drug business activities。This triggers the opposition of the pharmaceutical retail industry。

 

  The drug Stake Sports BettingElectronic supervision code system has been criticized since its establishment，The regulatory role that can be played by the drug electronic supervision code is very limited，Can't regulate the hospital's hospital that accounts for 80%of the drugs，Similarly，Although it can be supervised to the retail side，But the investment cost is large，And Ali's health exclusive operation of China Pharmaceutical Electronic Supervision Network，Fair competition、Information Security and other issues cannot be guaranteed to many industries.。

 

  and on the other side，At the end of last year，The Opinions on Accelerating the Construction of Important Product Traceback System issued by the State Council clearly requires that it is based on implementing the responsibility of corporate traceability management，Strengthen the main responsibility of the enterprise，Construction source can be checked、Go to chase、Important product traceability system。This makes the existence of the pharmaceutical Stake Sports BettingElectronic supervision code，Become a repeated construction project。

 

  January 25, 2016，Hunan Yangtian and Big Pharmacy are dissatisfied with CFDA strong push drug Stake Sports BettingElectronic supervision code，Litigation to court，Request & ldquo; Confirm the administrative violation of CFDA for compulsory implementation of electronic regulatory codes，Order the State Food Supervision Administration immediately stopped illegal act & rdquo;。The sound of the opposition to the electronic supervision code of the drug is getting louder and louder，The subsequent vaccine incident further confirmed the weak role of the electronic regulatory code in supervision and management。

 

  February，CFDA issued announcement，Relevant regulations for suspension of implementation of drug Stake Sports BettingElectronic supervision，At the same time, the "Specification of the Quality Management of Drugs" (revised draft) publicly solicited opinions from the society，The main revision direction is to cancel the drug electronic supervision code。Now the revised version of GSP announced，4 contents that are directly deleted are regulations on the drug regulatory code in the old version of the drug GSP，& ldquo; Article 81、Article 82、Article 102、Article 176 & rdquo;。

 

  Among the 11 modified 1，Article 57 Delete & ldquo; and meet the implementation conditions of drug Stake Sports BettingElectronic supervision & rdquo; words，change Article 161 to Article 158，Delete & ldquo; Pharmaceuticals that implement electronic regulatory code，It should also be in accordance with this specification & rdquo;stake online sports betting，Article 81、Article 82 provisions & ldquo; Perform stake sports betting appcode scanning and data upload & rdquo;，and changed Article 84 to Article 82，Also delete the description of the electronic regulatory code。

 

  The entire drug GSP revised version，The full text does not have any electronic regulatory code word，For the entire pharmaceutical industry，The previous electronic regulatory code investment may be drifted all water。

 

  2. Emphasizing the construction of traceable system

 

  No Stake Sports BettingElectronic supervision code，The construction of the traceable system of drugs has been continuously strengthened，In order to cooperate with the "Opinions on Accelerating the Construction of Important Product Traceback System" issued by the State Council，April 28 this year，CFDA issued "Opinions on Further Improve the Save of the Drug (Draft for Opinions)。Draft of Opinions，Establishing a food and drug traceability system is the main responsibility of the enterprise，Food、Drug companies do not establish a traceability system，It will be suspected of illegal crimes。

 

  In this modified drug GSP，The modification of Article 2 of the General Principles is on the original basis，Add & ldquo; and establish a drug traceability system in accordance with relevant national requirements，Implement the pharmaceutical traceability & rdquo;; change the provisions of the original & ldquo; the original & ldquo; change the regulations of the execution of drugs and Stake Sports BettingElectronic supervision & rdquo; to the regulations of the traceability of the drug & rdquo; Article 38，The content of the drug retail quality management system is adjusted to Article 135，and modify the seventeenth item to & ldquo; the regulations of the traceability of the drug & rdquo;，Directly & ldquo; Implementation conditions to meet the implementation of drugs and electronic supervision & rdquo;。

 

  and the newly added & mdash; & mdash;，For anesthesia drugs、Psychiatric drugs、The requirements of the pharmaceutical easy toxic chemicals are & ldquo; traceability shall comply with relevant national regulations & rdquo;。

 

  In this drug GSP modification，A large number of & ldquo; traceability & rdquo; two words，but there is no traceability system for further explanation and requirements。but，"Opinions on Further Improve the Food and Drug Traceability System" (hereinafter referred to as & ldquo; "Opinions" & rdquo;) will be the revised version of the drug GSP supporting policy，This "Opinions" encourages the production and operation enterprises to use information technology to establish a food and drug traceability system; encourage information technology companies as third parties，Provide product traceability professional services。But it is also clearly required that food and drug supervision departments at all levels must not be forced to require food、Drug production and operation enterprises accept the traceability service of the designated professional information technology enterprise。

 

  Although the solicitation draft posted，I did not mention the pharmaceutical Stake Sports BettingElectronic stake online sports bettingsupervision stake betting appcode that had attracted widespread attention before，Avoid related companies & ldquo; Disputes that are both athletes and referees & rdquo;，However，Clarified the direction of electronic supervision。This also allows Ali Health to decide to build it again、Market -based third -party traceability platform provides opportunities。

 

  It is understood，Alibaba Health Tracing New Platform will be compatible with & ldquo; Chinese pharmaceutical Stake Sports BettingElectronic supervision code & rdquo; technical standards，At the same time, the service for medical institutions and pharmaceutical companies on the former China Pharmaceutical Electronics Supervision Network will provide free services to the new platform。Ali Jiankang said，In the next three years，Alibaba Health is exempted from charging the code to the company、Cost of basic traceability services such as flowing to query，It will only charge data storage、Discipline calling and other technical support costs。

 

  This can be seen，Drug GSP revision，Emphasizing the construction of the traceable system，Then after matching "Opinions"，The Stake Sports BettingElectronic supervision code seems to be a means of traceable system dominated by the enterprise，Although the company is not forced，But the request to establish a traceability system has to allow some companies to cooperate with Ali Health。Of course，There are also many pharmaceutical companies，In the past many years, in order to control the terminal，Create a tracing checking system。No compulsory，At least it will make the market not monopolized by a company。

 

  3. Clarify the vaccine distribution qualification

 

  The emergence of this year's vaccine incident，Make the drug GSP system hit again，So，In this revision，Many adjustments have been made for cold chain transportation and vaccine distribution。

 

  In Article 22 of this modification，More clear the nature of the enterprise。It was before revised，& ldquo; Enterprises operating vaccines should also be equipped with more than 2 professional and technical personnel responsible for vaccine quality management and acceptance work，Professional and technical personnel should have preventive medicine、Pharmacy、Microbiology or medicine, etc.，And has more than 3 years of vaccine management or technical work experience & rdquo;。And now the general & ldquo; corporate & rdquo; modify the & hellip; & hellip; & rdquo;, which is engaged in vaccine delivery;，further clarifying the main body of the enterprise，easy product traceability and accountability。

 

  and the adjustment of the cold chain is，Article 49 of the Drug GSP before modified is & ldquo;、Frozen drugs，It should be equipped with facilities and equipment & rdquo;，and chose to modify it to & ldquo; storage、Transportation refrigerated、Frozen drugs，It should be equipped with facilities and equipment & rdquo;。From the perspective of changes，Enterprises equipped with these businesses have previously required stake sports betting appstake sports betting appto be equipped with equipment，What is required now is that companies that do these drugs must be equipped with equipment，The main body changed。

 

  Actually，Change of the main body of the two，Mainly because of the "Decision of the State Council on Modifying & LT; Vaccination and Prevention Management Regulations & GT;，Modify the relevant provisions of the Vaccine Management Enterprise in the "Scope of Quality Management of Drug Operations" into the requirements of vaccine distribution enterprises。

 

  Another，Article 62 The modification is also very important，The second item of this article is & ldquo; copy of the business license and its annual report company of the previous year & rdquo; and the sixth "Tax Registration Certificate" and the "Organization Code Certificate" should be checked The original seal of the first camp enterprise factory，Now based on the "Opinions on the Reform of the General Office of the State Council & ldquo; Three Certificate One & RDQUO; Registration System Reform，Merge the documents that the first camp needs to check into & ldquo; business license、Tax registration、Copy documents of the organization code & rdquo;。