据国家医保局官微最新消息，针对DAEWOONG BIO INC.注射用头孢地嗪钠在国家组织集采中的中选资格，国家组织药品联合采购办公室已做出决定，取消其中选资格，并将其列入违规名单。此决定基于DAEWOONG BIO INC.未按要求接受国家药监局进行的境外现场动态检查的事实。该检查发现，DAEWOONG BIO INC.的产品未能达到国家药监局设定的质量标准。
国家药监局将此次检查结果判定为“不符合要求”，并据此对注射用头孢地嗪钠采取了暂停进口、销售和使用的紧急措施。这一决定旨在保障公众用药安全，维护国家药品集采制度的公正性和严肃性。
DAEWOONG BIO INC.作为此次事件的涉事企业，不仅面临中选资格的取消，还被正式列入违规名单。这不仅对其在华市场运营造成重大影响，也将对其全球声誉产生深远的负面效应。此次事件再次提醒所有医药企业，必须严格遵守药品质量标准和相关法律法规，确保药品质量，维护患者健康权益。
国家组织药品联合采购办公室表示，将继续加强对中选药品的监管，对任何违规行为采取零容忍态度。此举不仅体现了国家对药品质量的高度重视，也展示了国家维护药品市场秩序、保障公众健康的坚定决心。未来，国家将不断优化药品集采机制，确保药品质量，降低患者负担，促进医药行业健康发展。
英语如下：
Headline: “DAEWOONG BIO INC. Loses Eligibility for Drug Selection in National Joint Procurement”
Keywords: National Joint Procurement, DAEWOONG BIO, Loss of Eligibility
Content: Headline: National Joint Procurement Office Cuts DAEWOONG BIO INC. off the List for Nebivolol Injection in National Group Procurement
In the latest update from the official Weibo account of the National Medical Insurance Bureau, the National Joint Procurement Office has made a decision to revoke the selection eligibility of DAEWOONG BIO INC.’s Nebivolol Injection in the national group procurement process. This decision, which includes placing the company on a blacklist for violations, is based on DAEWOONG BIO INC.’s failure to comply with the requirement of undergoing an on-site dynamic inspection by the National Medical Products Administration (NMPA). The inspection revealed that the company’s products did not meet the quality standards set by the NMPA.
The NMPA has deemed the inspection result as “not meeting requirements,” and as a result, has implemented an urgent ban on the import, sale, and use of the Nebivolol Injection. This measure is taken to ensure public health and uphold the fairness and seriousness of the national drug procurement system.
As a result of this incident, DAEWOONG BIO INC., the involved company, not only loses its selection eligibility but is also officially listed on the blacklist for violations. This decision has significant impacts on the company’s operations in China and will likely have long-lasting negative effects on its global reputation. This event serves as a reminder to all pharmaceutical companies that they must strictly adhere to drug quality standards and relevant laws and regulations, ensuring drug quality and safeguarding patients’ rights.
The National Joint Procurement Office has expressed its commitment to strengthening supervision over selected drugs and adopting a zero-tolerance policy towards any violation. This reflects the country’s high emphasis on drug quality and its determination to maintain market order and public health. In the future, the country will continue to optimize the drug procurement mechanism, ensuring drug quality, reducing patients’ burden, and promoting the healthy development of the pharmaceutical industry.
【来源】http://www.chinanews.com/life/2024/07-19/10253687.shtml
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