At the National Food and Drug Medical Device Inspection TV conference held in Beijing on the 28th, we learned that in 2011, the passing rate of China's national drug evaluation sample testing was 96.82%, and the pass rate of essential drugs was 97%.
According to reports, in 2011, the China Food and Drug Testing Institute conducted a total of 13,000 batches of various types of inspection products, including registration inspection, import inspection, and supervision inspection. In the National Drug Evaluative Sampling Examination, a total of 30,000 samples of 211 varieties were sampled with a pass rate of 96.82%; more than 25,000 batches of essential drug samples were drawn, with a pass rate of 97%.
Bi Zhenjia, deputy director of the State Food and Drug Administration, said at the meeting that the nationwide drug inspection system had completed the task of sampling and testing all varieties of basic drugs in 2011, providing scientific data support for ensuring the quality of essential drugs and accurately assessing the drug safety situation.
It is understood that at present, China has formed a relatively complete pharmaceutical production and supply system, and basically established a safety supervision system covering the whole process of drug development, production, circulation and use, and the drug safety situation has been significantly improved, and drug safety protection capabilities have been significantly improved. However, problems such as the lack of a sound corporate credit system, weak supervisory power, and weak technical support system still exist, and drug safety is still at a high risk.
According to the National Drug Safety Plan (2011-2015), China will further improve the inspection and inspection system and strengthen the quality management of medicines and medical devices throughout the process. By 2015, the production of drugs should be 100% in line with the newly revised "Pharmaceutical Production Quality Management Practice" requirement.
According to reports, in 2011, the China Food and Drug Testing Institute conducted a total of 13,000 batches of various types of inspection products, including registration inspection, import inspection, and supervision inspection. In the National Drug Evaluative Sampling Examination, a total of 30,000 samples of 211 varieties were sampled with a pass rate of 96.82%; more than 25,000 batches of essential drug samples were drawn, with a pass rate of 97%.
Bi Zhenjia, deputy director of the State Food and Drug Administration, said at the meeting that the nationwide drug inspection system had completed the task of sampling and testing all varieties of basic drugs in 2011, providing scientific data support for ensuring the quality of essential drugs and accurately assessing the drug safety situation.
It is understood that at present, China has formed a relatively complete pharmaceutical production and supply system, and basically established a safety supervision system covering the whole process of drug development, production, circulation and use, and the drug safety situation has been significantly improved, and drug safety protection capabilities have been significantly improved. However, problems such as the lack of a sound corporate credit system, weak supervisory power, and weak technical support system still exist, and drug safety is still at a high risk.
According to the National Drug Safety Plan (2011-2015), China will further improve the inspection and inspection system and strengthen the quality management of medicines and medical devices throughout the process. By 2015, the production of drugs should be 100% in line with the newly revised "Pharmaceutical Production Quality Management Practice" requirement.
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