生活-English中成药市场即将迎来大洗牌

为了消费者的用药安全，药监局”重拳出击”。当”用了很多年”不再是借口，中成药市场即将迎来大洗牌China Titans Safety Rules For Traditional Patent Medicines.

中国国家药品监督管理局（NMPA）宣布，更严格的安全信息披露要求将于2026年7月起实施。China’s National Medical Products Administration (NMPA) has announced that stricter safety information disclosure requirements will be implemented from July

这一举措或迫使大量传统中成药退出市场 This move may force a large number of traditional Chinese patent medicines to exit the market

早在2023年，相关监管部门就发布了配套细则，并为企业完善药品说明书及相关资料设定了三年过渡期。As early as 2023, the relevant regulatory authorities released supporting rules and set a three-year transition period for companies to improve package inserts and related materials.

因此自7月1日起，药品说明书若仍未明确标注禁忌、不良反应、注意事项等安全信息，其再注册申请将被驳回。Therefore, starting from July 1, medicines whose labels still fail to clearly state safety information—such as contraindications, adverse reactions, or precautions—will have their re-registration applications rejected.

业内预估，这一规定可能影响我国约5.7万个已获批中成药品种中的70%以上，其中不少品种至今仍缺乏完整的上市后安全数据。Industry estimates suggest that this rule could affect over 70% of China’s roughly 57,000 approved traditional patent medicines, many of which still lack complete post-marketing safety data.

国家药监局解释称，安全信息披露模糊的问题在行业内长期存在，监管部门希望推动药品上市许可持有人在药品获批后开展更全面的安全监测，而非单纯依赖其历史使用情况。The NMPA explained that vague safety disclosures have long been common in the industry, and regulators want to push drug license holders to conduct more thorough safety monitoring after approval, rather than relying solely on historical use.

去年相关执法工作已提速，国家药监局彼时发布多份通知，要求修订常用中成药说明书的安全信息，为即将开展的再注册工作做好准备。

Enforcement already accelerated last year, when the NMPA issued several notices requiring revisions to safety information on labels of commonly used traditional medicines to prepare for the upcoming re-registration process.

监管部门表示，这一转变是中国中医药行业的一个转折点，因为“单靠历史使用情况，已无法让产品符合现代安全标准”。According to regulators, the shift represents a turning point for China’s traditional medicine industry, because “historical usage alone will no longer protect products from modern safety standards.”

专家表示，这一新举措旨在让中医药领域更贴合循证药学监管要求，此举或将提升公众信任度，推动行业发展。Experts say the new approach aims to align the traditional medicine sector more closely with evidence-based pharmaceutical oversight, which could improve public confidence and promote industry development.

尽管这一过渡阶段对部分生产企业构成挑战，但也表明在我国不断发展的医疗健康体系中，消费者安全将被置于更重要的位置。Although the transition poses challenges for some manufacturers, it also signals that consumer safety will be given greater priority in China’s evolving healthcare landscape.

英语知识点解析：

1. – National Medical Products

Administration (NMPA)：

中国国家药品监督管理局

– safety information disclosure：

安全信息披露

– implement：v. 实施、执行

2. – this move：这一举措/此举

– force sb. to do sth.：迫使某人做某事，

– traditional Chinese patent medicines：传统中成药，patent medicines “中成药”，非“专利药”

– exit the market：退出市场，同义有

withdraw from the market、

be withdrawn from the market 。

3.– relevant regulatory authorities：