Three years of pharmaceutical reform, five major changes, affecting all pharmaceutical companies
Source:赛柏蓝
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Author:赛柏蓝
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Published time: 2018-08-20
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Imitation should be "the same"
China is generics superpower, but the quality of generic drugs and curative effect with the original research there is large gap, the foreign original medicine patent period in China is still at a high price and continue to monopoly market, caused a huge burden to patients, March 5, 2016, The General Office of the State Council about the opinions of the consistency to carry out the quality of generic drugs and curative effect evaluation, requirements of generic drugs to consistent with the quality of the original drug effect, and provisions of the national basic medicine catalogue (2012 edition) approved before October 1, 2007 of 289 chemicals generics oral solid preparation, should be finished by the end of 2018 consistency evaluation, If the same variety of other drug manufacturers has not been completed within three years after the self-confessed varieties have passed the consistency evaluation, they shall not be re-registered. If there are more than 3 manufacturers of the same variety of drugs that have passed the consistency evaluation, the varieties that have not passed the consistency evaluation will no longer be selected for centralized drug procurement. If there are not more than 3, the varieties that have passed the consistency evaluation will be given priority to purchase and use.
