The Department of General Affairs of the National Medical Products Administration ("NMPA") and the General Office of the National Health Commission ("NHC") have recently issued the Circular on Working Effectively on Building the Vaccine Information Traceability Systems (the "Circular").
The Circular calls for efforts to propel the building of information traceability systems that cover every process related to vaccines, including production, circulation and vaccination, in order to make all vaccines traceable in each process, ascertain their sources and whereabouts and make accountability possible, and thus effectively safeguard the quality and safety of vaccines. To this end, the Circular lays down key tasks in five aspects, including formulating unified traceability criteria and norms, and developing the coordinated service platform for vaccine traceability and the regulatory system in this regard. According to the Circular, marketing authorization holders shall bear the major responsibility for developing the vaccine information traceability system, develop the vaccine information traceability system under the principle of "one code for one product and tracing the product and the code at the same time", and link their respective system to the aforesaid coordinated service platform; they shall assign codes to all vaccines they produce, provide the traceable data on production and circulation of vaccines in different packaging units, and make it possible to check the traceable vaccine information. Moreover, the Circular makes arrangements for work on such systems on a pilot basis in seven regions, including Beijing, to take the lead in accomplishing the building of vaccine information traceability systems there.