Food and Drug Administration released on July 20, 2016 "Decision of the State Food and Drug Administration on Modification & LT; Drug Operation Quality Management & GT;，Announced the "Specifications for the Management of Drug Management Quality Management" (hereinafter referred to as drug GSP)。The modified 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 referred to as the following abbreviation 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 play to the main role of the enterprise，Move the basic principles of enthusiasm in all aspects。To implement the spirit of Circular 95，Implementing the management responsibility of pharmaceutical business stake betting appstake betting appenterprises，Strengthen the consciousness of the main body of the enterprise，Promoting the source of construction can be checked、Go chase、Responsible pharmaceutical full chain traceability system，You need to modify the relevant provisions of the electronic supervision in the original drug GSP。
April 23, 2016，The State Council issued the "Decision on Amending the" Regulations on the Management of Vaccination and Prevention "(State Council Order No. 668)，Cancellation of the regulations on the operating vaccine of the drug wholesale enterprise，Sell and distribute directly from the vaccine manufacturer to the disease control institution。You need to make a corresponding modification of the regulations on vaccine operation in the original drug GSP。
According to the "Opinions of the General Office of the State Council on Accelerating the Reform of the Registration System of the Three Certificate" (National Office [2015] No. 50)，Original use of the organization code certificate、Tax Registration Certificate to handle related affairs，All the business licenses after using the "three certificates"，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. The main content of the 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 bettingstake online sports bettingbusiness management as an enterprise、One means to ensure the quality of drugs。But anesthetic drugs、The varieties stipulated in laws and 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 the basic positioning and requirements of the construction of a drug traceability system。Divide the original head of the original general into two models，Added in the second paragraph "and establish a drug traceability system in accordance with the relevant national requirements，Implementation of drugs traceable。"adds one to the assignment:" 181 anesthesia drugs、Psychiatric drugs、The traceability of the pharmaceutical easy toxic chemicals shall comply with relevant national regulations。”
2. Delete or modify the content involved in the compulsory requirements of electronic regulatory code and data upload。
(1) Delete the original 81st、Original Article 82、Original 102、Original 176。
(2) Delete Article 84 "Code and Data Upload of Drug Electronic Supervision Code"、In Article 161 "Pharmaceuticals Implementation of Electronic Supervision，It should also be in accordance with Article 81 of this specification、Article 82 provisions perform code scanning and data upload "。
3. The enterprise quality management system shall be modified to "regulations for execution of drugs and electronic supervision" in the project to "regulations for drug traceability"。Specifically involved Article 36 (Twenty -first) item、Original Article 138 (17) item (17)。
4. Delete or modify the content of the implementation conditions of the computer system to meet the implementation of drugs and electronic supervision。
(1) Delete My stake betting appthe Stake Sports Bettingcontent of "and meet the implementation conditions of drugs and electronic supervision" in Article 57。
(2) Article 149 of the original into Article 149 "Enterprises shall establish a computer system that can meet the requirements of operation and quality management，and meet the requirements of drug traceability "。

(2) Terms involved in vaccine requirements
According to the State Council of the State Council No. 668，Modify the two regulations of the original pharmaceutical GSP on the two places of vaccine operation enterprises and vaccine operations，Change to regulations for vaccine distribution activities。Specifically:
1. Article 22 of the original paragraph 2 "Enterprises operating vaccines shall also be equipped with more than 2 professional and technical personnel responsible for vaccine quality management and acceptance work"，Modified to " for vaccine distribution，It should also be equipped with 2 or more professional and technical personnel responsible for vaccine quality management and acceptance。"stricter requirements for vaccine distribution companies，to facilitate improving the quality of participating in the distribution of enterprises，Strict control of quantity。
2. Article 49 of the original "operate refrigerated、Frozen drugs "modified to" store、Transportation refrigerated、Frozen drugs ";" Those who operate the vaccine should be equipped with more than two independent cold storage "，Modified to "Storage of the vaccine should be equipped with more than two independent cold storage"。

(3) Involved in checking tax registration、Terms required by the organizational code certificate
According to the National Office [2015] No. 50 Documents，Article 62 of the original GSP of the original enterprise required for review and inspection of the document (6) provided in the document required by the first camp, the "Tax Registration Certificate" and the "Copy of the Organization Code Certificate"，merged stake sports betting appinto stake sports betting appitem (2) item，Become a "business license、Tax registration、Copy documents of the organization code，Publicity of the annual report of the company of the previous year "，in order to facilitate the implementation of enterprises。

(4) Terms involved in the 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 the section 79 of the "Drug Management Law" cited in Article 186 of the original drug GSP to Article 70。