China’s State Food and Drug Administration (SFDA) has released a draft of a new regulation that would significantly expand the supply chain auditing and filing requirements for manufacturers of active pharmaceutical ingredients (APIs) and packaging as well as drug products.
Among other provisions, the regulation would require that manufacturers of APIs and “pharmaceutical auxiliary materials” conduct audits of the “qualification and quality assurance system” of the suppliers of their starting materials and intermediate products, and submit the audit reports with their filing information.
The proposed regulation represents an aggressive step by the Chinese government toward building a system that can address the problems of contaminated and sub-quality products that have plagued both the domestic and global marketplace.
SFDA notes that the document reflects an effort to borrow from and build on the drug master file (DMF) system in the US and Europe and to address the lack of traceability and transparency that has hampered SFDA from tackling the problems in the Chinese supply chain.
The Chinese regulatory agency is also taking a westernized approach in the way in which it is asking for comments.
Comments from “relevant divisions, bureaus and directly reporting units” of the SFDA and the food and drug administration agencies of “all provinces, autonomous regions and municipalities” are requested to be submitted by October 15. Significantly, SFDA is also reaching out for public input. Other “units or individuals” will have until October 30 to supply comments.
[More on the draft SFDA regulation and its significance is available for subscribers here. For IPQ subscription information, click here.]
