The State Food and Drug Administration (SFDA) held the National Working Conference on Rectifying and Standardizing Drug Market Order in Beijing on May 30, 2006 to launch a special nationwide campaign to rectify and standardize the drug market order. Wu Yi, member of the Political Bureau of the CPC Central Committee and Vice Premier of the State Council, issued important instructions relating to the campaign.
This campaign will start from June 2006 and include tasks in the following areas:
First, drug research and development. Product safety will be ensured from the very beginning by severely punishing falsification and enhancing evaluation and examination to rise to the challenges of too many and chaotic applications for drug registration. Registration applications will be fully checked up, particularly intensifying on-site examination to drug registration applications. Any falsification will be punished by law, recorded and made public. Injections will be subject to stricter evaluation and examination and higher standards will be set for injections. Also, the registration of medical devices will be checked up.
Second, drug manufacturing. The implementation of Good Manufacturing Practices (GMP) will be fully examined. Illegal activities will be detected through follow-up inspections and unannounced GMP inspections. Enterprises with chaotic management, illegal production or distinct quality risks will be severely punished. The management of medical institution pharmaceutical preparation will be strengthened. The quality assurance systems of the manufactures of key products and high-risk products will be fully examined.
Third, drug circulation. Unlicensed drug supply, "adjunct" drug supply or any other illegal distribution activities will be punished and banned by law. Special supervision and examination to the circulation of Chinese crude drugs, prepared slices of Chinese crude drugs and vaccines will be organized. Drug packaging, labels and insert sheets will continue to be standardized as required by SFDA to standardize the use of drug names. Routine supervision will also be strengthened. Good Supply Practices (GSP) follow-up inspections will be conducted. If the product is promoted in illegal advertisements, is complained by users or pose quality risks, spot checks will be conducted and immediate actions and legal measures will be taken against any counterfeit or substandard drugs and medical devices.
Fourth, drug use. Drugs on the market will be under strict supervision to find the problem and handle the problem timely, and prevent and reduce drug misadventuring. On the one hand, adverse drug reaction and medical device adverse event monitoring and reporting system will be improved. Implementation of monitoring measures in local areas will be examined. The warning and publicity of severe adverse reactions will be improved. Key products will be re-evaluated to eliminate any unsafe and ineffective products. On the other hand, drug regulation in medical institutions will be standardized and the publicity, education, management and monitoring of clinical rational drug use will be intensified by cooperating with healthcare departments.