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  • Henry Zhuang
    Henry Zhuang
    The company name is only visible to registered members.
    New rules on pharmaceutical GMP authentication
    On 2 August 2011, PRC State Food and Drug Administration promulgated new rules on pharmaceutical GMP authentication, which superseded the old corresponding rules enacted in 2005.

    New rules state that the authorities in charge of pharmaceutical GMP authentication should still be FDA (Food and Drug Administration) at provincial level or above (the “Competent FDA”). However, the new rules stipulate that before the final approval being granted and GMP certificate being issued by the Competent FDA, a pharmaceutical authentication and inspection institution (the “Authentication Institution”) established by the Competent FDA shall undertake the detailed examination work, such as technical inspection, on-site examination, comprehensive assessment and public announcement, etc.. New rules also introduced relevant assessment principles.

    In comparison with the old rules, the new rules have made some adjustments to the authentication procedures. The revised procedures are generally summarized as follows:

    1. After the application for GMP authentication is accepted by the Competent FDA, the Authentication Institution shall conduct technical inspection and complete the same within 20 working days (if the applicant is required to submit supplementary materials, the aforesaid time frame can be extended accordingly).

    2. After completion of the technical inspection, the Authentication Institution will prepare a plan for on-site examination and complete the same within 40 working days.

    3. Within 10 working days after completion of on-site examination, the examination team shall report to the Authentication Institution for comprehensive assessment.

    4. The Authentication Institution shall complete the comprehensive assessment within 40 working days after its receipt of the adjustment plan from the applicant (if an on-site verification is required, the above time frame can be extended accordingly).

    5. Upon completion of the comprehensive assessment, the Authentication Institution will make a 10 working days’ public announcement (if there is an objection, the authentication procedures will be suspended for the period of relevant investigations and verifications). Thereafter, the Authentication Institution will report to the Competent FDA for final examination and approval.

    6. The Competent FDA will complete the examination within 20 working days and the GMP Certificate will be issued to the applicant if its application is approved.

    E-mail: henryzhuang@hzlawyers.com
    Website: http://www.hzlawyers.com
    • 08 Aug 2011, 6:43 pm