The National Medical Products Administration ("NMPA") has recently issued the Announcement on Matters Concerning Further Improvement to the Correlated Evaluation, Examination, Approval and Regulation of Drugs (the "Announcement"), with effect from August 15, 2019.
The Announcement clarifies matters concerning correlated evaluation, examination and approval, and regulation of bulk pharmaceutical chemicals (BPCs), pharmaceutical excipients, and packaging materials and containers with immediate contact with drugs (collectively as BPCs, excipients and packaging), and pharmaceutical preparations, from four perspectives of general requirements, product registration administration, use and management of registered information on BPCs, excipients and packaging, and supervision and administration. The Announcement provides that registrants of BPCs, excipients and packaging shall take the responsibility for maintaining the registered information on the registration platform and bear liability for truthfulness and completeness of the registered data. An applicant claiming the registration of pharmaceutical preparations shall provide the registration numbers of BPCs, excipients and packaging and the letter of authorized use issued by the registrants of BPCs, excipients and packaging, while filing an application for drug registration. Applicants claiming the registration of pharmaceutical preparations or drug marketing authorization holders shall bear primary responsibility for drug quality, and, pursuant to relevant requirements for drug registration administration and for post-marketing production management, audit the quality management systems of suppliers of BPCs, excipients and packaging, in order to make sure they are qualifying to be used for pharmaceutical purposes.