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Email:
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| Name: |
Requirements for Onsite Verification for Drug Registration |
| Type： |
Regulation |
Issuing
Agency ： |
SFDA |
| Categories： |
Drug Registration |
Effective
Date: |
2008-06-04 |
Withdraw/
Expiry Date: |
n/a |
| Summary： |
SFDA issued “Requirements for Onsite Verification for Drug Registration” on June 4 as a supplemental regulation of the Provisions for Drug Registration with effect immediately.
The new rule clarifies and defines relevant requirements relating to onsite inspections under the Provisions for Drug Registration.
The new rule has seven chapters, 59 articles and five appendices. It was developed in accordance with relevant stipulations in the Provisions for Drug Registration and is designed to ensure truthfulness, accuracy and completeness of drug registration dossiers. Public comments were sought in 2007 for the rule, and they were taken into considerations in the final version.
Onsite verifications are divided by the new rule into four stages including preclinical research site inspection, clinical trial site inspection, trial production site inspection and normal production site inspection.
Specific requirements about inspectors, process, information and samples as well as various inspection criteria and standards are specified in the new rule.
The new rule also defines the roles and responsibilities of various government departments, including the SFDA, its GMP Certification Administrative Center, its Drug Evaluation Center, and provincial level drug administrations, in the process of onsite inspection for drug registration.
In addition, the new rule covers not only new drug registration applications, but also registration applications for generic drugs and clinical studies under supplemental applications. |
Additional
Info/Comments: |
n/a |
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