Reflections on the Requirements for Production Lines in Application of Chemical Drugs in China / 中国药学杂志

ABSTRACT

OBJECTIVE: The manufacturing site of drugs is a combination of a series of production factors to meet the requirements of drugs production, which is not only the material basis of drugs production, but also the evaluation basis for the review when applying for registration. The purpose of this paper is to preliminarily discuss the definition and extension of production lines for chemical drugs in China, and provide some references for standardizing new drug application. METHODS: The historical requirements for manufacturing site information in application materials of chemical drugs in China were briefly introduced, with daily pharmaceutical evaluation works and specific cases study. RESULTS: AND CONCLUSION: It should make clear the definition and extension of production lines in the application materials, strengthen the effective communication between different regulatory authorities, update the relevant information in time, and should pay continuing attention to the revision progress of the laws and regulations requirements on the production line in China.