Drug regulator tightens safety rules, prompting exit of tradtional Chinese patent medicines

(ECNS) - China's drug regulator will require a large number of traditional Chinese patent medicines to withdraw from the market starting in July, as stricter safety disclosure requirements reach a key enforcement deadline, according to media reports.

From July 1, the National Medical Products Administration (NMPA) will reject re-registration applications for traditional Chinese medicines whose labels still list contraindications, adverse reactions, or precautions as "unclear," according to official regulatory rules. The requirement applies three years after the regulation took effect in July 2023.

The move could affect more than 70% of China's roughly 57,000 valid approvals for traditional Chinese patent medicines, many of which still lack complete post-marketing safety data, industry estimates show.

The rule, outlined in Article 75 of the NMPA's special provisions on traditional Chinese medicine registration, is intended to end the long-standing practice of vague safety disclosures and push drug license holders to strengthen post-approval safety monitoring, regulators said.

Regulatory enforcement has already accelerated. Throughout last year, the NMPA issued multiple notices requiring revisions to safety information on the labels of commonly used traditional medicines, in preparation for the upcoming re-registration process.

The sweeping enforcement marks a turning point for China's traditional medicine industry, signaling that historical use alone will no longer shield products from modern safety standards as regulators move to align the sector more closely with evidence-based pharmaceutical oversight.

(By Zhang Jiahao)