149 drug over consistency evaluation

This winter, it's a bit cold, especially for the pharmaceutical industry When it comes to policies that will continue to have a significant impact on the pharmaceutical industry throughout 2018 and 2019, it's not "consistency assessment" ▍ there are two more drugs The first one passed the consistency evaluation Although on December 28, 2018, the State Food and Drug Administration officially issued a document to specify the end of year extension of the consistency evaluation, before the notice was issued, according to the original provisions of the "289 catalog" by the end of 2018, the varieties must pass the consistency evaluation, especially the end of the year, so that many pharmaceutical enterprises are walking on thin ice At the beginning of the new year, all pharmaceutical companies have not slacked off and are still working hard on the road of consistency evaluation Recently, the author inquired the catalogue of Chinese listed drugs and found that two more drugs passed the consistency evaluation of quality and efficacy, namely, ruiglinide tablets (1mg) of Jiangsu Haosen Pharmaceutical Co., Ltd and acyclovir tablets (0.2g) of Shandong Qidu Pharmaceutical Co., Ltd., both of which passed the consistency evaluation first According to the statistics of cypress blue, up to now, 149 products have passed or deemed to pass the consistency evaluation, only 55 products belong to the "289 catalog", involving 26 varieties in total Among the products that have passed or are deemed to have passed the consistency evaluation, 10 varieties have reached 3 enterprises The details are as follows: ▍ consistency evaluation, the big limit is still in the last few days of 2018, and the State Food and Drug Administration officially issued a document to clarify the extension of the big limit at the end of the year, but it must be noted that the big limit is still in place The State Food and drug administration clearly requires that for generic drugs including essential drug varieties approved for listing before the implementation of new registration and classification of chemical drugs, the consistency evaluation of the same varieties of other drug manufacturers shall be completed within 3 years in principle after the first varieties pass the consistency evaluation With more and more varieties passing the consistency evaluation, the three-year period after the first evaluation is under increasing pressure for many enterprises When it comes to consistency evaluation, many pharmaceutical companies are caught off guard by the policies related to consistency evaluation According to the opinions on the evaluation of the consistency of quality and efficacy of generic drugs (GBF [2016] No 8), if there are more than three manufacturers of the same kind of drugs that have passed the consistency evaluation, the varieties that have not passed the consistency evaluation will not be used in the centralized purchase of drugs At present, Jiangsu, Jiangxi, Heilongjiang, Guangxi and other places have successively issued the notice of suspension of purchase without passing the consistency evaluation, and many drugs have been suspended In addition to the above provinces, according to the statistics of cypress blue, up to now, many provinces and cities such as Zhejiang, Hunan, Fujian, Tianjin, Hebei, Jilin, Liaoning, Shaanxi, Gansu, etc., have also suspended the purchase of drugs without conformity evaluation In addition, the impact of national volume procurement on the pharmaceutical industry is also huge From the outflow of the first batch of national volume procurement list to the announcement of the results of 4 + 7 urban volume procurement, the pharmaceutical sector experienced many big shocks In the 4 + 7 urban volume procurement, the purchased varieties are only the original research drugs, the drugs that pass or are deemed to pass the consistency evaluation, and the drugs that fail the consistency evaluation have no chance to declare Although it is difficult and stressful, consistency evaluation is imperative In order to develop better in the future, this is the way that all generic pharmaceutical enterprises must go Attachment: summary of 149 varieties passing the consistency evaluation (as of January 6)