Guidance on drug traceability will be issued

Source: Pharmaceutical cloud studio yesterday (August 7), 2017-08-09, CFDA, together with the Ministry of Finance and the national health and Family Planning Commission, gave a reply to the proposal of the public platform for full traceability of medical equipment information, which further clarified: 1 Pharmaceutical enterprises are the main body of the construction of drug traceability system The pharmaceutical production and marketing enterprises should build their own or independently choose a third party to build the system, and ultimately realize the information traceability of the whole chain with the minimum package of one thing and one code, and create the whole process of information traceability chain from production, circulation to consumption On the one hand, the construction of drug traceability system is not a small cost for the enterprises, so we should choose the right one Choosing a third party is undoubtedly the most economical and affordable way Who will be the third party, who will still hold the pipa half covered; on the other hand, under the system, drugs will enter the terminal sales from delivery to circulation, and the lifeline of drug price will be firmly grasped 2 At present, a unified operation standard has been initially formed, supporting coexistence of multiple codes, supporting data interconnection, and giving full play to the role of the industry Shandong, Shanghai, Ningxia and Xiamen will first build the system with financial support, focusing on products such as traditional Chinese medicine, and take the lead in docking with enterprise information 3 Collect all-round traceability information of drug production, circulation and use Encourage industry organizations to establish data collaboration platform, support data interconnection between drug traceability platforms, and realize data exchange and sharing 4 The guiding opinions on the construction of traceability system for pharmaceutical manufacturing and trading enterprises will be issued soon, the standards for drug traceability information will be formulated and issued, the requirements for traceability related to medical device regulatory laws and regulations will be implemented, and the whole traceability process will be controllable Member Qu Qian: we have received your proposal on speeding up the establishment of a public platform for tracing the whole process of medical equipment information Now, together with the Ministry of Finance and the national health and Family Planning Commission, we reply as follows: The opinions of the general office of the State Council on accelerating the construction of traceability system for important products (GBF [2015] No 95) pointed out that the construction of traceability system should be based on the implementation of enterprise traceability management responsibility, adhere to the combination of government guidance and market-oriented operation, give play to the role of enterprise main body, and mobilize the enthusiasm of all aspects In September 2016, our bureau issued the opinions on promoting food and drug producers and operators to improve the traceability system (sfyjk [2016] No 122), which clarified the responsibility system of establishing traceability system in China, enterprises undertaking the main responsibility of traceability system construction, and supervision and inspection by regulatory authorities, encouraged producers and operators to use information technology to establish traceability system, and required the food and drug regulatory authorities to Law urges inspection, encourages industry associations to organize enterprises to build traceability information query platform to provide data services for all parties Pharmaceutical medical device traceability system is an important part of the quality and safety management system of pharmaceutical medical device manufacturers and operators Pharmaceutical medical device manufacturers and operators shall bear the main responsibility for the construction of traceability system, so as to realize the traceability of the source and destination of the products they produce and operate In case of quality and safety problems, they can timely recall relevant products and find out the reasons It is of great significance to establish the traceability system of medical devices for improving the overall safety level of medical devices in China and promoting the healthy development of the industry 1、 On the construction of drug traceability system According to the requirements of the relevant documents of the State Council and the State Food and drug administration, the food and drug regulatory system has made clear the principle that the construction of drug traceability system is based on the enterprise, the national standards and systems, organized and carried out the research of "using information technology to support the construction of drug traceability system", and actively explored and promoted the construction of drug traceability system At present, it has initially formed a unified operation standard, supporting coexistence of multiple codes, supporting data interconnection, and giving play to the main role of the industry Preliminary research results have been obtained on several key issues of your concern Drugs are different from ordinary commodities The most rigorous standards and the most strict supervision are the important guarantee of public drug safety The construction of drug traceability system should be carried out in stages according to the actual situation, and the information traceability of the minimum package one item one code in the whole process of the whole chain should be finally realized Drug traceability platform is an important means for enterprises to achieve product market management It should play the role of the main body of the enterprise, and be built by the drug production and marketing enterprises themselves or by the third party of their own choice The platform is compatible with the product codes that meet the technical requirements, and collects the traceability information of drug production, circulation and use in an all-round way Encourage industry organizations to establish data collaboration platform, support data interconnection between drug traceability platforms, and realize data exchange and sharing At present, our bureau is studying and planning the information standard system of drug traceability, and formulating the coding standard, interface standard, data transmission standard and safety standard of drug traceability It supports the coexistence of multiple codes, which are compatible with both the original drug electronic supervision code and the international general code The traceability system is independently selected and built by the enterprise At the beginning of 2017, our bureau published the information of "national drug coding standard code" as a whole, providing basic standard data for enterprises to prepare drug traceability code In order to implement the spirit of relevant documents of the State Council, the Ministry of Finance and the Ministry of Commerce launched the construction of traceability system for important products in 2016 The central government allocated 700 million yuan to support the construction of traceability system in Shandong, Shanghai, Ningxia and Xiamen Focusing on products such as traditional Chinese medicine, support the construction of traceability public information platform, encourage relevant enterprises to carry out necessary facilities transformation according to the needs of traceability system construction, build a whole process information traceability chain from production, circulation to consumption, reduce transaction costs such as consumer rights protection, and meet the needs of consumer upgrading 2、 On the one hand, on the construction of medical device traceability system, our bureau constantly improves the requirements of laws and regulations In the normative documents such as the production quality management specification of medical devices, the appendix of the production quality management specification of medical devices implantable medical devices, the management measures for the operation supervision of medical devices, the management specification for the operation quality of medical devices, the management measures for the use quality supervision of medical devices, etc., the retroactive records and informatization of the production and operation of medical devices are clearly specified To promote the construction of traceability system On the other hand, actively promote the construction of coding system In 2014, our bureau established a leading group for medical device coding and formulated a coding system construction work plan Continuously strengthen the research work, understand the relevant situation of medical device coding at home and abroad, and track the latest progress of international unique identification On this basis, based on the international advanced experience, combined with China's national conditions and the characteristics of medical device products, and in accordance with the requirements of traceability system construction, further modify and improve the work plan of medical device coding system construction, research and formulate coding rules, coding related technical standards and coding database construction plan 3、 In the next step, our bureau will issue guidance on the construction of traceability system for pharmaceutical manufacturing and trading enterprises as soon as possible, formulate and issue drug traceability information standards, promote the implementation of traceability requirements of medical device regulatory laws and regulations, and achieve full traceability control At the same time, strengthen the communication and cooperation with relevant departments, continue to give full play to the supervision and guidance of regulatory departments and the guidance of industry associations, encourage the research and development of advanced Traceability Technology, jointly promote the establishment and improvement of traceability system for pharmaceutical and medical device production and operation enterprises, and ensure the safety of pharmaceutical and medical devices Thank you for your concern and support for the safety of medical devices Food and Drug Administration August 1, 2017