Field, the State Council, 'National drug safety' second five 'plan' submitted for the approval of generic drugs by 2007, with the batches of generic drugs for quality conformance assessment, not by evaluating the generic drug will be canceled . Food Drug Administration set up generic quality conformance evaluation office (hereinafter referred to as the Office of Evaluation), is responsible for implementing these plans. It is understood that their work processes from the bottom up, first by the Evaluation Office to determine the evaluation methods and standards, provincial drug authorities responsible for receiving data, production site inspection and sampling, the Office of Evaluation Committee of Experts to review the organization. However, the vested interests of the game intersectoral substantive progress has been slow. Evaluation Office preliminary goal is to complete 75 base types of drugs, seized the hospital until April 20, 2015 completed the initial research methods 34 species, examined by experts through evaluation methods 9 species, 41 species are in the method of the research stage . These work according to plan, this should be completed in 2013-2014. Press the 'Twelfth Five-Year Plan', 570 kinds into the national essential drugs list and a chemical commonly used in clinical medicine completed in 2015. 570 kinds of commonly used drugs involved 2400 enterprises, 33,000 batches. The industry consensus is that the 2015 target could not be completed on time. From the technical analysis, generic evaluation of conformity does not exist problem. 'Japan has been in place for 18 years, technology is mature, the question is whether policy makers are determined.' A local instrument for Drug Control officials on the 'Financial' reporter said. In 1998, due to the low efficacy of generic drugs in Japan started 'Drug quality re-evaluation project', mainly the drug for efficacy, administration to give businesses some time to allow its secondary development, during this time can not the withdrawal must be complete batch. 1970s, the United States through bioequivalence, out of about 6,000 kinds of substandard medicines. Once enhance the efficacy of the real thing, it means you want to cut a large number of substandard pharmaceutical companies. Planned 2015 completion of 570 kinds of medicines, create a lot of value for the pharmaceutical industry each year. Local officials Food and Drug Control, said, 'Revolution is necessary to move vested interests 'cheese', does not regulate the pharmaceutical companies would lose the most, and they are
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