National Medical Products Administration will develop technical standards for drug traceability to trace the source and whereabouts of drugs


On August 26, 2019, after the 12th session of the 13th Standing Committee of the National People’s Congress, the General Office of the NPC Standing Committee held a press conference for officials to answer to reporters’ questions about the law that was passed by vote at the meeting. When talking about the drug traceability system, the Director of the Division of Policy and Law in the National Medical Products Administration (NMPA) LIU Pei said that the NMPA is setting up a platform for drug traceability coordination and supervision, and will release a series of technical standards for traceability to ensure that the sources and whereabouts of all kinds of drugs can be traced.

The 12th session of the 13th Standing Committee of the NPC approved the revised Drug Administration Law with 164 votes in favor and three abstentions. Article 12 of the newly revised Drug Administration Law stipulates that the state shall establish a drug traceability system and the pharmaceutical supervisory and administrative departments under the State Council shall develop unified standards and specifications.

LIU Pei said: “In the General Provisions of the Drug Administration Law, it is stipulated that the state shall establish and improve the drug traceability system, which ensures the quality and safety of drug production and management in an IT-based way, in an attempt to prevent counterfeit and inferior drugs from entering the market and enable drug risk control and accurate recall”. He also mentions that the drug traceability system focuses on “one drug one code, and one code to trace everywhere”. Drug marketing license holders should establish a drug traceability system to trace and verify even the smallest packaging unit of drugs. The general principle of the drug traceability system is that regulatory departments should develop standards to form a system in which different kinds of codes are used. In other words, the original electronic regulatory code should be compatible with other codes like those commonly used internationally to give full play to the main role of enterprises.

According to the Drug Administration Law, holders of marketing licenses, manufacturing enterprises and medical institutions should establish their own traceability system and share data with each other. LIU Pei says the NMPA is also setting up a traceability coordination platform and monitoring platform, and will issue a series of technical standards for traceability, so that all relevant departments can have a unified standard specification for the traceability system. The traceability system is also mentioned in the Vaccine Law.

LIU Pei said: “The NMPA has already issued some regulations, such as drug traceability coding requirements, and it will make clear the relevant requirements to achieve the traceability of sources and whereabouts of drugs throughout their whole distribution process”.