The National Medical Products Administration ("NMPA") has recently issued five standards, including the Basic Dataset for Drug Manufacturer Traceability (Draft for Comment) (the "Draft for Comment"), the Basic Dataset for Drug Operator Traceability (Draft for Comment) and Basic Dataset for Drug User Traceability (Draft for Comment), to seek public comments by October 11, 2019.
The Draft for Comment includes the scope, referenced normative documents, terms and definitions, categories of datasets and contents of datasets. Among others, the Draft for Comment states that basic datasets for drug traceability are classified into two categories, namely, data subsets for basic information and data subsets for application information. The former covers the basic data distributed by collaborative service platforms for drug traceability, and supplements thereto, while the latter covers all traceable information generated throughout the entire process, ranging from drug production, drug circulation to drug use.