The State Drug Administration recently issued an announcement. In order to ensure the safety of public drug use, China will convert non-prescription drugs from Yumei preparations to prescription drugs and manage them according to prescription drugs. The announcement requires that relevant drug marketing license holders should submit a supplementary application to the Drug Evaluation Center of the State Drug Administration before November 30, 2026 in accordance with the “Administrative Measures on Drug Registration” and other relevant regulations. Other contents of the instructions are revised in accordance with prescription drug requirements, and that drug labels should be revised as needed. After approval of the supplementary application to amend the drug instructions, the relevant drug marketing license holder shall replace the drug instructions and labels that have already left the factory within 9 months, or inform patients in other forms. At the same time, information on adverse reactions should be collected and reported in a timely manner to do a good job of risk control and pharmacovigilance.

Zhitongcaijing · 2d ago
The State Drug Administration recently issued an announcement. In order to ensure the safety of public drug use, China will convert non-prescription drugs from Yumei preparations to prescription drugs and manage them according to prescription drugs. The announcement requires that relevant drug marketing license holders should submit a supplementary application to the Drug Evaluation Center of the State Drug Administration before November 30, 2026 in accordance with the “Administrative Measures on Drug Registration” and other relevant regulations. Other contents of the instructions are revised in accordance with prescription drug requirements, and that drug labels should be revised as needed. After approval of the supplementary application to amend the drug instructions, the relevant drug marketing license holder shall replace the drug instructions and labels that have already left the factory within 9 months, or inform patients in other forms. At the same time, information on adverse reactions should be collected and reported in a timely manner to do a good job of risk control and pharmacovigilance.