Selection and Switch-to-OTC of Chinese Patent Medicines in China

doi:10.19803/j.1672-8629.2020.11.08

Abstract

Abstract: Objective To review some of the Chinese patent medicines that have been selected or switched to over-the-counter (OTC) products in China so as to provide reference for the switch of prescription drugs to OTC (Rx-to-OTC) drugs in China. Methods Regulations on classification management of prescription and nonprescription drugs and the history of Rx-to-OTC switch were reviewed. Chinese patent medicines which were selected as and switched to OTC drugs were analyzed separately. Results On the basis of the list of generic drugs,there were more than 3 900 OTC Chinese patent medicines,including 3 406 medicines that had been selected as OTC drugs between 1999 and 2004,535 ones that had been switched to OTC,and 25 OTC Chinese patent medicines switched to prescription drugs in the same period. Conclusion The application materials should meet the requirements of regulations on Rx-to-OTC switch applications, After switch to OTC drugs,marketing authorization holders (MAHs) should ensure the safety of these drugs, find effective ways to collect adverse reaction(ADR)reports that should be analyzed to improve the safety instructions of the OTC label. MAHs should be responsible for drug safety for the sake of patients.

Key words: classification management of prescription and non-prescription drugs, OTC, Chinese patent medicines, Rx-to-OTC switch, OTC -to Rx - switch

CLC Number:

R286

ZHU Lan, Shao Bo, XIA Dongsheng. Selection and Switch-to-OTC of Chinese Patent Medicines in China[J]. Chinese Journal of Pharmacovigilance, 2020, 17(11): 785-789.

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