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In recent years, China's pharmaceutical regulatory system has undergone major changes, with the aim of achieving the effects of management jump, concept renewal and technological progress, which has led to close study and exchange between the Chinese pharmaceutical industry and the foreign pharmaceutical industry.

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Since the reform and opening up, with the continuous advancement of medical technology, China's drug review standards have been continuously improved. Past drug review standards have not mandated that generic drugs are consistent with the quality and efficacy of original drugs, so some drugs have certain efficacy and original drug.

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The problems existing in the drug registration management at that time and the shortcomings of the Drug Registration Management Measures implemented at that time were revised again.