"Technical Guidelines for Pharmaceutical Change Research of Listed Chemical Drugs (Trial)" Questions and Answers on Changes of API"
Release time:
2024-07-05
In order to standardize and guide the research work that relevant preparation holders should carry out when the production process, production site, production batch, quality standards, etc. of chemical raw materials are changed, and to further clarify the technical requirements of relevant preparations when the suppliers of raw materials used in preparations are changed, under the deployment of the State Drug Administration, the Drug Review Center has organized and formulated the "Technical Guidelines for Pharmaceutical Change Research of Listed Chemical Drugs (Trial)" Questions and Answers on Changes of Raw Materials (see Annex). In accordance with the requirements of the Notice of the General Department of the State Food and Drug Administration on the Issuance of the Procedures for the Issuance of the Technical Guidelines for Drugs (No. 9 [2020] of the State Food and Drug Administration), and upon examination and approval by the State Food and Drug Administration, it is hereby promulgated and shall come into force on the date of promulgation.
In order to standardize and guide the research work that relevant preparation holders should carry out when the production process, production site, production batch, quality standards, etc. of chemical raw materials are changed, and to further clarify the technical requirements of relevant preparations when the suppliers of raw materials used in preparations are changed, under the deployment of the State Drug Administration, the Drug Review Center has organized and formulated the "Technical Guidelines for Pharmaceutical Change Research of Listed Chemical Drugs (Trial)" Questions and Answers on Changes of Raw Materials (see Annex). In accordance with the requirements of the Notice of the General Department of the State Food and Drug Administration on the Issuance of the Procedures for the Issuance of the Technical Guidelines for Drugs (No. 9 [2020] of the State Food and Drug Administration), and upon examination and approval by the State Food and Drug Administration, it is hereby promulgated and shall come into force on the date of promulgation.
Attachment: Questions and answers on changes of raw material drugs in Technical Guidelines for Pharmaceutical Changes of Listed Chemical Drugs (Trial) Main contents of the questions and answers on changes of raw material drugs:
1. Overview
When there is a post-marketing change of the 2. API or a change in the supplier of the API used in the preparation, the relevant preparation shall be combined with the change of the API to evaluate the consistency before and after the change of the API.
3. there is a post-marketing change in the API, what research should the formulation holder undertake?
What studies should the formulation holder undertake 4. change the supplier of the drug substance used in the formulation?
5. References
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