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    SFDA requires further intensifying the supervision and management of drug manufacturers 5/31/2006
    To further intensify the supervision and management of drug production and ensure the safe use of drugs, the State Food and Drug Administration (SFDA) issued a notice on May 18, 2006, requiring drug regulatory departments of provinces, autonomous regions and municipalities to further strengthen the supervision and management of drug manufacturers.

    The Notice requires that drug regulatory departments at all levels shall attach great importance to the routine supervision and management of drug manufacturers, implement the supervision responsibility in real earnest and effectively ensure the quality of drug production; intensify routine supervision to drug manufactures according to the requirements of Drug Administration Law of the People's Republic of China and Provisions for the Supervision of Drug Manufacturing; urge drug manufacturers to improve the product quality assurance system according to the requirements of GMP and make it operate effectively and guarantee the product quality; immediately organize the audit of the suppliers of raw materials and excipients of the drug manufacturers and organize an all-round checkup of the procurement and quality testing of the bought raw materials and excipients, material management and product examination and release. At the same time, drug manufacturers are required to procure materials from companies meeting the requirements and put the materials in storage after quality certification and the production and testing should strictly under drug quality standards.

    The Notice also requires drug regulatory departments to intensify the supervision and inspection efforts on drug manufacturers after GMP certification, continue to do well the follow-up inspections and unannounced GMP inspections and attach importance to the examination of manufactures' newly approved products after GMP certification. To defects found in the inspection, drug regulatory departments shall supervise the manufacturers to make timely rectification; to illegal activities found, shall be investigated thoroughly and be dealt with in accordance with law; to those which don't meet the standards for GMP certification, the GMP certificate shall be taken back in accordance with law; and if the circumstances are serious, the Drug Manufacturing Certificate shall be revoked in accordance with law.

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