2015年《国务院关于改革药品医疗器械审评审批制度的意见》(国发〔2015〕44号)发布以来,中国制药工业掀起了以创新为基调的空前变革,一方面对已上市的17万个批文开启了一致性评价,另一方面实施药品上市许可人制度,使药品批文与药品生产企业解绑,终止新的药品生产企业的继续上马,提高行业产能利用率。
<<After the No.44 document being issued in 2015,an unprecedented reform based on innovation spread across the pharmaceutical industry in China.On one hand,170000 marketed drugs on the market are undergoing the consistency evaluation;on the other hand,the adoption of MAH(Marketing Authorization Holder) unties the bond between drug approvals and drug manufacturing enterprises,keeps new drug manufacturing enterprises from entering the market,and improves the utilization rate of the industry's capacity.
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