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| Guiding Opinions of the National Medical Products Administration on the Construction of IT-Based Drug Traceability Systems | | 国家药监局关于药品信息化追溯体系建设的指导意见 |
| (No. 35 [2018] of the National Medical Products Administration) | | （国药监药管〔2018〕35号） |
For the purposes of implementing the Opinions of the General Office of the State Council on Accelerating the Construction of Traceability Systems for Major Products (No. 95 [2015], General Office of the State Council) and further improving the quality safety assurance for drugs, according to the Opinions of the China Food and Drug Administration on Promoting Food and Drug Producers and Operators in Improving Traceability Systems | | 为贯彻落实《国务院办公厅关于加快推进重要产品追溯体系建设的意见》（国办发〔2015〕95号），进一步提高药品质量安全保障水平，根据《食品药品监管总局关于推动食品药品生产经营者完善追溯体系的意见》（食药监科〔2016〕122号）和商务部等部门《关于推进重要产品信息化追溯体系建设的指导意见》（商秩发〔2017〕53号）等有关规定，现就建立药品信息化追溯体系提出如下指导意见。 |
| I. Guiding ideology | | 一、指导思想 |
| In accordance with the decisions and arrangements of the CPC Central Committee and the State Council, with the aim of safeguarding drug safety for the general public, based on the implementation of the primary responsibility of enterprises, in the direction of “one code for one item and concurrent traceability of the code and item,” the construction of IT-based i drug traceability systems shall be accelerated, and the exchange and sharing of traceability information shall be enhanced, so as to realize traceability for all varieties and the whole process, promote the comprehensive governance of drug quality safety, and improve the quality safety assurance for drugs. | | 按照党中央、国务院决策部署，以保障公众用药安全为目标，以落实企业主体责任为基础，以实现“一物一码，物码同追”为方向，加快推进药品信息化追溯体系建设，强化追溯信息互通共享，实现全品种、全过程追溯，促进药品质量安全综合治理，提升药品质量安全保障水平。 |
| II. Work objectives | | 二、工作目标 |
| Marketing authorization holders, production enterprises, operation enterprises, and user entities shall establish drug traceability systems by means of information technology, promptly and accurately record and preserve drug traceability data, form a drug traceability data link of connectivity, achieve the traceability of sources and whereabouts of drugs in the whole process from drug production, circulation to use, effectively prevent illegal drugs from entering legal channels, and ensure that drugs carrying quality safety risk are susceptible to recall and liability is investigated. | | 药品上市许可持有人、生产企业、经营企业、使用单位通过信息化手段建立药品追溯系统，及时准确记录、保存药品追溯数据，形成互联互通药品追溯数据链，实现药品生产、流通和使用全过程来源可查、去向可追；有效防范非法药品进入合法渠道；确保发生质量安全风险的药品可召回、责任可追究。 |
| Drug traceability systems covering the whole process shall be commonly established at drug production, circulation and use links, the quality management level of marketing authorization holders, production enterprises, distribution enterprises and user entities shall be obviously raised, the IT-based regulation level and regulatory efficiency of drug regulatory authorities shall be gradually raised, and industry associations shall actively play a bridging, leading and demonstrating role in the construction of the IT-based drug traceability systems, so that the IT-based drug traceability data can be independently verified by the general public and the public awareness of IT-based drug traceability can be raised. | | 药品生产、流通和使用等环节共同建成覆盖全过程的药品追溯系统，药品上市许可持有人、生产企业、经营企业、使用单位质量管理水平明显提升，药品监督管理部门的监管信息化水平和监管效率逐步提高，行业协会积极发挥药品信息化追溯体系建设的桥梁纽带和引领示范作用，实现药品信息化追溯数据社会公众可自主查验，提升全社会对药品信息化追溯的认知度。 |
| III. Basic principles | | 三、基本原则 |
1. Marketing authorization holders, production enterprises, distribution enterprises and user entities shall assume their respective responsibilities. Marketing authorization holders, production enterprises, operation enterprises and user entities, as responsible bodies for drug quality safety, shall have the obligation of traceability. Marketing authorization holders and production enterprises shall assume the primary responsibility for the construction of drug traceability systems, and drug distribution enterprises and user entities shall cooperate with marketing authorization holders and production enterprises in establishing a sound drug traceability system and fulfill their respective traceability responsibilities.
．．．．．． | | （一）药品上市许可持有人、生产企业、经营企业、使用单位各负其责。药品上市许可持有人、生产企业、经营企业、使用单位是药品质量安全的责任主体，负有追溯义务。药品上市许可持有人和生产企业承担药品追溯系统建设的主要责任，药品经营企业和使用单位应当配合药品上市许可持有人和生产企业，建成完整药品追溯系统，履行各自追溯责任。
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