As per the Notice, China NMPA announces that on-site inspections are required for the following scenarios:
There are changes in the formulation, manufacturing process, inner packaging materials, and manufacturing equipment for injections. The changes fall into Category III changes or major changes stipulated in the Technical Guidelines for Researches on Changes to Drugs with Marketing Authorization (I) and Technical Guidelines for Researches on Changes to the Manufacturing Process of Drugs with Marketing Authorization.
The production location (production line) of domestic preparations has changed.
This is the first time for the applicant to submit an application for chemical drug injections, and the corresponding production has not been utilized to produce other drugs. (Note: “Other drug” refers to a drug containing a different active pharmaceutical ingredient).
During the drug review, the application is found with authenticity questions that need to be verified.
CDE has received complaints and reports on issues of authenticity and reliability, which require verification.