Drug safety promulgated in the twelfth five-year period, and drug standards will be raised in China within five years
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The plan proposes that during the “Twelfth Five-Year Planâ€, the National Drug Standard Improvement Action Plan will be implemented, priority will be given to raising the quality standards for essential medicines and high-risk medicines, and to improve the quality standards and concoction specifications for Chinese medicine (ethnic materials) and ethnic medicines (materials). At the same time, the National Medical Device Standard Improvement Action Plan will be implemented to improve the quality of generic drugs in an all-round way, and a national drug standard management system centered on the "Pharmacopoeia of the People's Republic of China" will be established.
According to the plan, 6500 drug standards will be completed in the next five years, including 2,500 chemical drugs, 2,800 Chinese patent medicines, 200 biological products, 350 Chinese herbal medicines, and 650 pieces of Chinese herbal medicines. Raise 139 standards for packaging materials that are in direct contact with drugs, and establish standards for 100 commonly used packaging materials for direct contact with drugs.
In improving the level of drug safety monitoring and early warning, China will strengthen the construction of municipal and county-level monitoring agencies. The proportion of reported cases of adverse drug reactions in counties (cities, districts) reached more than 80%, and the number of adverse drug reaction reports reached 400 copies per million people.