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Email:
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| Name: |
Technical Standards for Drug Evaluation |
| Type： |
Guidelines |
Issuing
Agency ： |
SFDA |
| Categories： |
Drug Registration |
Effective
Date: |
2008-06-03 |
Withdraw/
Expiry Date: |
n/a |
| Summary： |
On the basis of its document “Work Plan for Centralized Evaluation of Products in the Transitional Period”, and in accordance with Provisions for Drug Registration and its relevant technical guidelines, the State Food and Drug Administration (SFDA) developed and issued following five technical standards for drug evaluation on June 3, 2008 with effect immediately.
1.Technical Standards for Chemical Drugs
2.Technical Standards for Multi-component Biochemical Drugs
3.Standards and Rules for Determination of Ambiguous Traditional Chinese Medicine Quality Standards
4.Rules for Traditional Chinese Medicines Containing Endangered Herbal Materials
5.Standards for Determining Truthfulness of Research Data and Graphs of Chemical Drugs
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Additional
Info/Comments: |
These technical standards are designed to help SFDA's drug evaluation officials and experts quickly determine deficiencies of drug registration applications in the “transitional period” (applications received before October 1, 2007 when the new Provisions of Drug Registration was issued) so that the speed of evaluation of such applications will be accelerated. |
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