Guiding Opinions of the National Medical Products Administration on the Building of Information-based Drug Traceability Systems
Guiding Opinions of the National Medical Products Administration on the Building of Information-based Drug Traceability Systems
Guiding Opinions of the National Medical Products Administration on the Building of Information-based Drug Traceability Systems
Guo Yao Jian Yao Guan [2018] No. 35
October 31, 2018
In accordance with the Opinions of the China Food and Drug Administration on Facilitating the Improvement of Traceability Systems by Food and Drug Manufacturers and Operators (Shi Yao Jian Ke [2016] No.122) and the Guiding Opinions on Promoting the Development of Information-based Traceability Systems for Key Products (Shang Zhi Fa [2017] No.53) of the Ministry of Commerce and other departments, the following guiding opinions on developing information-based drug traceability systems are hereby given in order to implement the Opinions of the General Office of the State Council on Accelerating the Development of Traceability Systems for Key Products (Guo Ban Fa [2015] No.95) and further improve the drug quality and safety assurance.
I. Guiding Ideology
In accordance with the decisions and deployments of the Central Committee of the Communist Party of China ("CPC") and the State Council, with an aim to guarantee the safety of drug use by the public, based on the implementation of the enterprises' primary responsibility and in the direction of realizing "one code for one product and tracing the product and the code at the same time", efforts shall be made to accelerate the development of an information-based traceability system for drugs, strengthen the exchange and sharing of traceability information, trace all varieties of drugs throughout the whole process, promote the comprehensive control of drug quality and safety, and improve drug quality and safety assurance.
II. Work Objectives
Drug marketing authorization holders (MAH), manufacturers, drug operators and entities using drugs shall establish a drug traceability system through information technology, keep record of and preserve the drug traceability information timely and accurately, build an interconnected data link of drug traceability information, so that the source can be enquired and the whereabouts can be traced during the whole process of drug manufacturing, circulation and use; illegal drugs can be effectively prevented from entering the legal channels; the drugs with quality and safety risks will be recalled and relevant parties liable be held accountable.
A whole-process drug traceability system shall be established for all links, from drug manufacturing, circulation to use. The quality control of drug MAH, manufacturers, operators and entities using drugs shall be significantly enhanced. The information application in regulation and the regulatory efficiency of drug regulators shall be gradually improved.
......
Guo Yao Jian Yao Guan [2018] No. 35
October 31, 2018
In accordance with the Opinions of the China Food and Drug Administration on Facilitating the Improvement of Traceability Systems by Food and Drug Manufacturers and Operators (Shi Yao Jian Ke [2016] No.122) and the Guiding Opinions on Promoting the Development of Information-based Traceability Systems for Key Products (Shang Zhi Fa [2017] No.53) of the Ministry of Commerce and other departments, the following guiding opinions on developing information-based drug traceability systems are hereby given in order to implement the Opinions of the General Office of the State Council on Accelerating the Development of Traceability Systems for Key Products (Guo Ban Fa [2015] No.95) and further improve the drug quality and safety assurance.
I. Guiding Ideology
In accordance with the decisions and deployments of the Central Committee of the Communist Party of China ("CPC") and the State Council, with an aim to guarantee the safety of drug use by the public, based on the implementation of the enterprises' primary responsibility and in the direction of realizing "one code for one product and tracing the product and the code at the same time", efforts shall be made to accelerate the development of an information-based traceability system for drugs, strengthen the exchange and sharing of traceability information, trace all varieties of drugs throughout the whole process, promote the comprehensive control of drug quality and safety, and improve drug quality and safety assurance.
II. Work Objectives
Drug marketing authorization holders (MAH), manufacturers, drug operators and entities using drugs shall establish a drug traceability system through information technology, keep record of and preserve the drug traceability information timely and accurately, build an interconnected data link of drug traceability information, so that the source can be enquired and the whereabouts can be traced during the whole process of drug manufacturing, circulation and use; illegal drugs can be effectively prevented from entering the legal channels; the drugs with quality and safety risks will be recalled and relevant parties liable be held accountable.
A whole-process drug traceability system shall be established for all links, from drug manufacturing, circulation to use. The quality control of drug MAH, manufacturers, operators and entities using drugs shall be significantly enhanced. The information application in regulation and the regulatory efficiency of drug regulators shall be gradually improved.
......