Department of Clinical Medicine (Pharmaceutical Medicine), Graduate School of Pharmaceutical Sciences, Kitasato University, 5-9-1 Shirokane, Minato-ku, Tokyo, 108-8641, Japan.
Ther Innov Regul Sci. 2022 Sep;56(5):839-847. doi: 10.1007/s43441-022-00431-y. Epub 2022 Jul 25.
Scientific information in the drug labeling is expected to be the most up-to-date and consistent information across countries where medicine is approved. The objective of the present study is to investigate the consistency of safety-related information on product labeling for novel therapeutics concurrently approved in Japan and the US.
Safety information at the time of initial approval of new drugs approved concurrently both in Japan and the US in the recent 7 years were identified and reviewed for concordance. Factors associated with the discordance were also investigated.
Despite the similar medical practices, population health, and regulation in Japan and the US, the level of concordance of safety information found in the drug labeling of 45 new active substances was low (20.4%). The development strategy of the drugs and having the same MAH were significantly associated with the concordance rate. The mean concordance rate among the 9 drugs with Black Box Warning in both countries was also low (32.9%).
We found a low level of concordance between Japan and the US even when related to clinically important information raised by Black Box Warnings. The low concordance rate highlighted the need for a greater transparency in decision-making processes about the safety information in a drug labeling by both industry and regulators to take appropriate countermeasures against the discordance.
药品标签中的科学信息应在药品获得批准的国家/地区保持最新且一致。本研究旨在调查在日本和美国同时批准的新型治疗药物的产品标签上的安全性信息的一致性。
确定并审查了在最近 7 年内日本和美国同时批准的新药首次批准时的安全性信息，以进行一致性评估。还调查了导致不一致的因素。
尽管日本和美国的医疗实践、人口健康和监管情况相似，但在 45 种新活性物质的药品标签中发现的安全性信息的一致性水平较低（20.4%）。药物的研发策略和拥有相同的 MAH 与一致性率显著相关。在两国均有黑框警告的 9 种药物中，平均一致性率也较低（32.9%）。
即使涉及到黑框警告中提出的临床重要信息，我们也发现日本和美国之间的一致性水平较低。低一致性率突出表明，行业和监管机构需要在药品标签的安全性信息决策过程中提高透明度，以针对不一致情况采取适当的对策。
