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    Home > Active Ingredient News > Drugs Articles > CFDA issued two consecutive documents: relevant provisions on suspension of drug electronic supervision and public solicitation for revision of GSP terms

    CFDA issued two consecutive documents: relevant provisions on suspension of drug electronic supervision and public solicitation for revision of GSP terms

    • Last Update: 2016-02-22
    • Source: Internet
    • Author: User
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    Source: the controversial electronic supervision code before 2016-02-21 section of pharmaceutical economic news has finally made the latest progress Today, CFDA official website issued two consecutive announcements on the issue of electronic supervision code of drugs, and made the latest statement on suspending the implementation of relevant provisions of 2015 No 1 announcement on electronic supervision of drugs (2016 No 40) Whereas, the general office of the State Council has implemented the opinions on accelerating the construction of traceability system for important products (GBF [2015] 95) (No.) for public comments on the revision of the contents of the electronic supervision of drugs in the pharmaceutical trading quality management specifications, and now it is decided to suspend the implementation of the relevant provisions of the announcement of the General Administration of food and Drug Administration on issues related to the full implementation of the electronic supervision of drugs by pharmaceutical production and trading enterprises (No 1 in 2015) The opinions of the General Administration of food and Drug Administration on the revision of the quality management regulations for drug distribution are to implement the opinions of the general office of the State Council on accelerating the construction of traceability system for important products (GBF [2015] 95) (No.) spirit, based on the implementation of the traceability management responsibility of enterprises, strengthening the main responsibility of enterprises, building a drug traceability system with traceable sources, whereabouts and responsibilities On the basis of listening to the opinions of some drug production enterprises, drug trading enterprises, relevant industry associations and experts, the food and drug administration drafted the "drug management quality management specification" (Revised Draft) Now, we are open to the public for comments Before March 23, 2016, all sectors of the society can put forward their opinions and suggestions in the following four ways: 1 Log in to the legal information network of the Chinese government (website: http://www.chinalaw.gov.cn) from February 23, and enter the "opinions collection system of departmental draft regulations" on the left side of the homepage to put forward their opinions and suggestions 2 Send the opinions and suggestions to xuxy@cfda.gov.cn Please indicate the subject of the email "feedback opinions on the quality management specifications for drug distribution" 3 Mail the opinions and suggestions to the legal department of the State Food and drug administration, building 2, No 26, Xuanwumen West Street, Xicheng District, Beijing (postcode: 100053), and mark the words "feedback opinions of the quality management specifications for drug trade" on the envelope 4 Fax the opinions and suggestions to 010-88330705 Annex: quality management specifications for drug distribution (Revised Draft) and notes on the quality management specifications for drug distribution (Revised Draft) I the necessity of revision I opinions on accelerating the establishment of traceability system for important products (GBF [2015] 95) issued by the general office of the State Council on December 30, 2015 According to the requirements of (No.), based on the implementation of the traceability management responsibility of the enterprise, strengthen the main responsibility of the enterprise, and build an important product traceability system with traceable sources, whereabouts and responsibilities In January 2013, the regulations on the quality management of drug trade (Order No 90 of the Ministry of Health) and the regulations on the quality management of drug trade (Order No 13 of the General Administration of drugs, hereinafter referred to as "drug GSP") revised by the General Administration of drugs are inconsistent with the requirements on the implementation of drug electronic supervision by drug dealers and the implementation of the responsibility of the enterprise's traceability subject, so it is necessary to implement the current drug GSP The relevant provisions in shall be modified and improved accordingly 2、 The main content of the revision is to adjust the drug electronic supervision system to the drug traceability system, emphasizing the establishment of the drug traceability system with the drug manufacturing and trading enterprises as the main responsibility The varieties of special drugs and other regulations shall be stipulated separately There are ten articles in the current drug GSP that involve drug electronic supervision, namely, Articles 36, 57, 81, 82, 84, 102, 138, 149, 161 and 176 In view of the relevant provisions are the specific operational requirements in the internal management system, receipt and acceptance, outbound or sales code scanning, computer management and other links of the enterprise, the revision of relevant contents does not involve the regulation structure adjustment, mainly changing the expression of "drug electronic supervision system" to "drug traceability system" In order to highlight the main responsibility of the independent construction of the enterprise, and cancel the requirements of compulsory implementation of electronic supervision code scanning and data upload The specific modifications include: (1) establishing the basic positioning and requirements for the construction of drug traceability system An article is added to the general provisions, which reads: "pharmaceutical trading enterprises shall, in accordance with the relevant requirements of the state, establish a drug traceability system, so as to realize that the source of drugs can be inspected, the destination can be traced, and the responsibility can be investigated." At the same time, considering that there are clear regulations and rules on the traceability of special drugs, an additional article is added in the annex, which is "the traceability system of drugs under special management shall comply with relevant national regulations" (2) Deleting or modifying contents involving mandatory electronic supervision code scanning and data upload Specifically including: 1 Delete the original article 81: "for drugs subject to electronic supervision, the enterprise shall scan the drug electronic supervision code according to the regulations and upload the data to the system platform of China drug electronic supervision network in a timely manner", and the original Article 102 "for drugs subject to electronic supervision, scan the code and upload the data when they are out of the warehouse" The original article 176 "for drugs subject to electronic supervision, code scanning and data uploading shall be carried out at the time of sale." 2 Delete the contents of "scan and upload the drug electronic supervision code and data" in the original Article 84 and "scan and upload the drug electronic supervision code and data in accordance with the provisions of Articles 81 and 82 of this specification" in the original article 161 3 In the original article 82, "if the enterprise fails to print or paste the Chinese drug electronic supervision code in accordance with the regulations, or the printing of the supervision code does not meet the requirements of the regulations, it shall reject it If the regulatory code information is inconsistent with the drug packaging information, it shall promptly inquire the supplier "and modify it to" the enterprise shall reject the drugs that cannot be traced back " If the traceability information is inconsistent with the drug packaging information, it shall be promptly inquired from the supplier " (3) The "provisions on the implementation of drug electronic supervision" is revised to "provisions on the implementation of drug traceability" It specifically involves item 21 of the original article 36 and item 17 of the original article 138 (4) Delete or modify the content that requires the enterprise computer system to "meet the implementation conditions of drug electronic supervision" Specifically include: 1 Delete the content of "and meet the implementation conditions of drug electronic supervision" in the original Article 57 2 The original Article 149 "an enterprise shall establish a computer system that can meet the requirements of operation and quality management and meet the implementation conditions of electronic supervision of drugs" is revised to "an enterprise shall establish a computer system that can meet the requirements of operation and quality management and meet the requirements of drug traceability".
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