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According to news from the Chinese government website, recently the State Council has issued the Twelfth Five-year Plan for National Drug Safety.
According to the report of Xinhua News Agency and news from the Chinese government website, the State Council has issued the Twelfth Five-year Plan for National Drug Safety, and proposed to significantly improve the drug quality and standards through 5 years efforts, to significantly increase the drug safety level and the masses’ medication safety satisfaction.
It is proposed in the plan to implement the improvement action plan of the national drug standards during the twelfth five-year plan, give the priority to improve the quality standards of basic drugs and high-risk drugs, and the quality standards and processing specifications of the traditional Chinese medicine (material) and national medicine (material), at the same time, implement the improvement action plan of the national medical device standards, comprehensively improve the quality of generic drugs, and perfect the national drug standard management system by taking Pharmacopoeia of the People's Republic of China" as the core.
According to the plan, the improvement work of standards for 6500 drugs will be completed in the next five years, including 2500 Chinese medicines, 2800 chemical medicine, 200 biological products, 350 traditional Chinese medicinal materials, and 650 traditional Chinese medicine decoction pieces. The packaging materials standards for 139 direct contact drugs will be improved, and the packaging material standards for 100 commonly-used direct contact drugs will be developed. The standards for 132 pharmaceutical excipients will be improved, and the standards for 200 pharmaceutical excipients will be developed.
In promoting drug safety monitoring and early warning levels, our government will strengthen the construction of municipal and county monitoring institutions. There are more than 80% of adverse drug reaction cases in county (city, area) report, and there are 400 adverse drug reaction cases per one million people. There ratio of adverse events of medical devices in county (city, area) reports is over70%, and the adverse event reports of medical devices per one million people are 400.
In order to crack down these behaviors of manufacturing and selling the counterfeit and low-quality drugs, the plan proposed that improve the department anti-counterfeiting collaboration mechanism, and accelerate the information platform construction of the cohesion of the administrative law enforcement and criminal justice. Improve the drug inspection appraisal mechanism, and improve counterfeit and low-quality drugs inspection appraisal limitation. Focus on cracking down the criminal activities of manufacturing and selling the counterfeit and low-quality drugs through the Internet, mail, attached and other methods, and resolutely crack down the criminal activities of importing and exporting the counterfeit and low-quality drugs. At the same time, thrash out the problems that the penalties for the crime for manufacturing and selling the counterfeit and low-quality drugs are too low, and increase penalties for the criminal behaviors of manufacturing and selling the counterfeit and low-quality drugs.
According to the goal determined by the plan, in the five years, the standards of all chemicals and biological products in China shall be at or near the international standards, and Chinese medicine standards are formulated in accordance with the international standards. The medical devices adopt international standards in 90% or more. The pharmaceutical production completely conforms to the requirements of "Good Manufacturing Practice" revised in 2010; sterile and implantable medical devices production completely conforms to the requirements of "Good Manufacturing Practice for Medical Apparatus and Instruments". The pharmaceutical trading completely conforms to the requirements of "Good Supply Practice".
It is proposed in the plan to implement the improvement action plan of the national drug standards during the twelfth five-year plan, give the priority to improve the quality standards of basic drugs and high-risk drugs, and the quality standards and processing specifications of the traditional Chinese medicine (material) and national medicine (material), at the same time, implement the improvement action plan of the national medical device standards, comprehensively improve the quality of generic drugs, and perfect the national drug standard management system by taking Pharmacopoeia of the People's Republic of China" as the core.
According to the plan, the improvement work of standards for 6500 drugs will be completed in the next five years, including 2500 Chinese medicines, 2800 chemical medicine, 200 biological products, 350 traditional Chinese medicinal materials, and 650 traditional Chinese medicine decoction pieces. The packaging materials standards for 139 direct contact drugs will be improved, and the packaging material standards for 100 commonly-used direct contact drugs will be developed. The standards for 132 pharmaceutical excipients will be improved, and the standards for 200 pharmaceutical excipients will be developed.
In promoting drug safety monitoring and early warning levels, our government will strengthen the construction of municipal and county monitoring institutions. There are more than 80% of adverse drug reaction cases in county (city, area) report, and there are 400 adverse drug reaction cases per one million people. There ratio of adverse events of medical devices in county (city, area) reports is over70%, and the adverse event reports of medical devices per one million people are 400.
In order to crack down these behaviors of manufacturing and selling the counterfeit and low-quality drugs, the plan proposed that improve the department anti-counterfeiting collaboration mechanism, and accelerate the information platform construction of the cohesion of the administrative law enforcement and criminal justice. Improve the drug inspection appraisal mechanism, and improve counterfeit and low-quality drugs inspection appraisal limitation. Focus on cracking down the criminal activities of manufacturing and selling the counterfeit and low-quality drugs through the Internet, mail, attached and other methods, and resolutely crack down the criminal activities of importing and exporting the counterfeit and low-quality drugs. At the same time, thrash out the problems that the penalties for the crime for manufacturing and selling the counterfeit and low-quality drugs are too low, and increase penalties for the criminal behaviors of manufacturing and selling the counterfeit and low-quality drugs.
According to the goal determined by the plan, in the five years, the standards of all chemicals and biological products in China shall be at or near the international standards, and Chinese medicine standards are formulated in accordance with the international standards. The medical devices adopt international standards in 90% or more. The pharmaceutical production completely conforms to the requirements of "Good Manufacturing Practice" revised in 2010; sterile and implantable medical devices production completely conforms to the requirements of "Good Manufacturing Practice for Medical Apparatus and Instruments". The pharmaceutical trading completely conforms to the requirements of "Good Supply Practice".
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