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| Name: |
Technical Guidelines for Post Approval Changes to Pharmaceuticals (1) |
| Type： |
Regulation |
Issuing
Agency ： |
SFDA |
| Categories： |
Drug Registration |
Effective
Date: |
2008-06-03 |
Withdraw/
Expiry Date: |
n/a |
| Summary： |
SFDA issued a new rule, “Technical Guidelines for Post Approval Changes to Pharmaceuticals (1)”, on June 3, 2008 with effect immediately.
The rule is developed in accordance with Provisions for Drug Registration, and designed to guide the necessary research work required for any alterations made to post-marketing pharmaceutical chemical products.
According to the new rule, “changes” refer to those changes made to the origins, methodologies and control parameters of post-marketing pharmaceutical chemical products in areas including production, quality control and application conditions. These alterations may affect the safety, efficacy and quality controllability of drug products.
The new rule covers following changes: 1) changes to the production process of API drugs; 2) changes to pharmaceutical inactive ingredients in the recipe and to the preparation process of drug formulations; 3) changes to registered drug standards; 4) changes to product specifications; 4) changes to expiration period and storage conditions; 5) changes to product packaging and containers; 6) changes of manufacturing sites of imported drugs or their APIs; 7) changes of manufacturing sites of APIs used in the locally-made drug formulations.
For all changes that are covered by this rule, supplemental applications must be made to the different levels of drug administrations in accordance to the requirements of the Provisions for Drug Registration. When in vivo bioequivalence studies or clinical trials are required for changes, supplementary applications shall be submitted to the SFDA.
The rule divides the changes covered by it into three categories. Category I includes minor changes that basically do not have any impacts on the safety, efficacy and quality controllability of drug products; category II includes medium scale changes that require relevant research work to prove they do not have impacts on the safety, efficacy and quality controllability of drug products; and category III includes relatively major changes that require relevant research work to prove they do not have negative impacts on the safety, efficacy and quality controllability of drug products.
The rule also provides that if “conclusions from other scientific research work can prove the changes do not have negative impacts on the safety, efficacy and quality controllability of the given drug products, on the basis of sufficient evidence, requirements of this rule does not need to be followed completely.”
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Additional
Info/Comments: |
To download the full text of this new rule in Chinese from the SFDA website, please click on the following link: http://www.sfda.gov.cn/WS01/CL0055/30232.html |
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