The National Medical Products Administration ("NMPA") has recently drafted and issued the Basic Dataset for Vaccine Traceability (Draft for Comment) (the "Draft for Comment"), the Basic Technical Requirements for Vaccine Traceability Data Exchange (Draft for Comment) and the Basic Technical Requirements for Vaccine Traceability Systems (Draft for Comment) for public consultation by June 15, 2019.
The Draft for Comment clearly states that this standard deals with the classification, relations between data providers, and data content, of basic datasets for vaccine traceability in relation to the building of the vaccine traceability framework, and may be used to guide the development of vaccine traceability systems. The Draft for Comment notes that basic datasets for vaccine traceability are classified into two categories, namely data subsets for basic information and data subsets for application information. The former consists of basic data distributed by collaborative service platforms for vaccine traceability, and supplements thereto, while the latter covers traceable information generated throughout the entire process of vaccines, ranging from the production, circulation and use. Traceable vaccine data providers include vaccine marketing authorization holders and vaccine makers, disease prevention and control agencies and entities in charge of vaccination.