Food and Drug Administration released on July 20, 2016, "Decision of the State Food and Drug Administration on Modifying & LT; Drug Business Quality Management & GT;，Announced the "Specifications for the Management of Drug Business Quality Management" (hereinafter referred to as drug GSP)。The modification content is now interpreted as follows: & lt; Drug business quality management specifications & gt;

 

  1. Modify the cause

 

  December 30, 2015，The General Office of the State Council issued the "Opinions on Accelerating the Construction of Important Product Traceback System" (National Office [2015] No. 95，The following is referred to as No. 95)，The construction of the product traceability system of drugs and other products clearly clearly adheres to the combination of government guidance and marketization operation，Give full play to the role of the enterprise，Move the basic principles of enthusiasm in all aspects。To implement the spirit of Circular 95，Implementation of the management responsibility of pharmaceutical business enterprises，Strengthen stake online sports bettingthe stake betting appconsciousness of the main body of the enterprise，Promoting the source of construction can be checked、Go to chase、Responsible pharmaceutical full chain traceability system，You need to modify the relevant regulations of the electronic supervision in the original drug GSP。

 

  April 23, 2016，The State Council issued the "Decision on Modifying & LT; Vaccine Circulation and Prevention Management Regulations & GT;" (State Council Order No. 668)，The regulations on the original regulations on the operating vaccine of the drug wholesale enterprise，Sell and distribute directly from vaccine manufacturers to disease control institutions。You need to make a corresponding modification of the regulations on vaccine operations in the original drug GSP。

 

  According to the "Opinions of the General Office of the State Council on accelerating & ldquo; Three Certificate One & RDQUO; Registration System Reform" (Guoqi Fa [2015] No. 50)，Original use of the organization code certificate、Tax Registration Certificate to apply for related affairs，All business licenses are changed to use & ldquo; three certificates and one & rdquo;，You need。

 

  According to the 14th meeting of the Standing Committee of the Twelfth National People's Congress, "Decision on Modification & LT; Drug Management Law & GT;，The newly announced "Drug Management Law" adjusted some provisions serial number，You need to modify the relevant provisions of the "Drug Management Law" in the original drug GSP。& lt; The Drug Management Law of the People's Republic of China & GT;

 

  2. Main content of modification

 

  (1) Terms involved in the retrospective requirements of drugs

 

  Based on the No. 95 file，Adjust the drug electronic supervision system into a drug traceability system，Requires the establishment of a corresponding management system in the quality management system，Implementation in the key drug business management link，Strengthen stake online sports bettingbusiness stake sports betting appmanagement as an enterprise、One means to ensure the quality of drugs。But anesthetic drugs、The varieties stipulated in the regulations of psychiatric drugs shall still be established by the drug regulatory department to establish a monitoring information network，Real -time monitoring of the number and flow of medicines in each link of enterprises。Specific modifications include:

 

  1. Establish basic positioning and requirements for the construction of the pharmaceutical traceability system。Divide the original total of the original generals into two models，Added & ldquo in the second paragraph and establish a drug traceability system in accordance with relevant national requirements，Implementation of drugs traceable。& rdquo; Add one to the attachment: & ldquo; 181 anesthesia drugs、Psychiatric drugs、The traceability of the pharmaceutical easy toxic chemicals shall comply with relevant national regulations。& rdquo;

 

  2. Delete or modify the content involved in the compulsory requirements of electronic regulatory code and data upload。

 

  (1) Delete Article 81、Original Article 82、Original 102、Original 176。

 

  (2) Delete the code and data upload of the original & ldquo; and the electronic supervision code of the drug & rdquo;、Original & ldquo; Pharmaceuticals implemented by electronic supervision，It should also be in accordance with Article 81 of this specification、Article 82 provisions perform code scanning and data upload & rdquo;。

 

  3. The enterprise quality management system should include & ldquo; regulations for implementing drug electronic supervision & rdquo; modify to & ldquo; Drug traceability regulations & rdquo;。Specifically involved Article 36 (Twenty -first)、Original Article 138 (17) item (17)。

 

  4. Delete or modify the content of the implementation of the Stake Sports Bettingimplementation conditions of the computer system to meet the implementation of drugs and electronic supervision。

 

  (1) Delete the original & ldquo; and meet the Stake Sports Bettingimplementation Stake Sports Bettingconditions of the drug electronic supervision & rdquo; content。

 

  (2) Modify Article 149 to & ldquo; Enterprises shall establish a computer system that can meet the requirements of operation and quality management，and meet the requirements of drug traceability & rdquo;。

 

  (2) Terms involved in vaccine requirements

 

  According to the Order of the State Council No. 668，Modify the two regulations of the original drug GSP on vaccine operations and vaccine operations，Change to regulations for vaccine distribution activities。Specifically:

 

  1. Article 22 of Article 22 & LDQUO; Enterprises operating vaccines should also be equipped with more than 2 professional and technical personnel responsible for vaccine quality management and acceptance work & rdquo;，Modified to & ldquo;，It should also be equipped with more than 2 professional and technical personnel responsible for vaccine quality management and acceptance。& rdquo; Rigid requirements for vaccine distribution companies，to facilitate improving the quality of participating in distribution enterprises，Strict control of quantity。

 

  2. The original 49th & ldquo;、& rdquo; Modified to & ldquo; storage、Transportation refrigerated、Frozen drugs & rdquo;; in the following (1) item & ldquo; operating vaccine shall be equipped with more than two independent cold storage & rdquo;，Modified to & ldquo; For the storage vaccine, more than two independent cold storage & rdquo;。

 

  (3) Involved in checking tax registration、Terms required by the Organization Code Certificate

 

  According to the National Office [2015] No. 50 Documents，Article 62 of the original GSP Enterprise required for review and inspection of the documents required by the first (6) item (6) & ldquo; "Tax Registration Certificate" and "Organization Code Certificate" copy & rdquo;，merged into item (2) item，Become & ldquo; business license、Tax registration、Copy documents of the organization code，and the annual report of the company of the previous year & rdquo;My stake betting app，so as to facilitate the implementation of enterprises。

 

  (4) Terms involved in stake online sports bettingthe sequence number of the "Drug Management Law"

 

  The 14th Meeting of the Standing Committee of the Twelfth National People's Congress revised the "Drug Management Law" announced by Article 79 to Article 70。So，Modify Article 79 of the "Drug Management Law" cited in Article 186 of the original drug GSP to Article 70。