Overall supervision of the State Food and Drug Time:2015-08-24
To further improve the overall supervision of the implementation of GMP work, August 11, 2004, the State Food and Drug Administration issued a "comprehensive supervision on the implementation of GMP for specific matters," which called provinces, autonomous regions and municipalities food and drug regulatory authorities should continue to strengthen the drug manufacturer discontinued the supervision and inspection, regular and irregular regular checks to ensure supervision of enterprises have ceased production are implemented. At the same time pay close attention to the market after the company discontinued the supply and social stability, to take timely and effective prevention and response measures to ensure the overall supervision of the implementation of GMP to work smoothly. Since July 1, 2004 until the end of 2004 to implement weekly reporting system.
"Notice" that in order to meet the needs of the pharmaceutical market, has the record for the ongoing transformation of GMP and the main project has been completed, is expected before the end of 2004 through the GMP certification of the enterprise (or formulation) of drugs involved, as indeed clinical needed, can be entrusted other to obtain the appropriate certificate of GMP production company, commissioned the production shall not exceed June 30, 2005. API shall not be commissioned production. According to the actual situation of discontinued businesses, discontinued businesses (or plant) in production before the end of June 2004 and has completed the preparation process of the products formed in the local drug regulatory department under the supervision of the production process can continue to complete the follow-up, and after inspection qualified sales.
"Notice" requirements, the provinces, autonomous regions and municipalities food and drug regulatory authorities should be further strengthened for the record company's drug GMP certification reconstruction work, the quality assurance certification. At the same time according to pharmaceutical companies to actively guide the rational adjustment of product structure, market conditions, to prevent blind investment and redundant construction. (2004.08.17)
