Study on the Management System of OTC Drug in Taiwan Are a of China Based on Consumer Guidance Perspective / 中国药房

ABSTRACT

OBJECTIVE： To provide reference for the improvement of OTC drug management system in mainland China. METHODS： By analyzing the classification， registration management， conversion procedures and supporting measures， instructions and packaging management of OTC drugs in Taiwan area of China， and considering the current situation and problems of OTC drug management in mainland China， suggestions for improving OTC drug management system in mainland China were put forward. RESULTS & CONCLUSIONS： OTC drugs of Taiwan area could be divided into drugs instructed by physicians and pharmacists （hereinafter referred to as “instructed drugs”） as well as patent drugs. The registration management of instructed drugs was implemented in accordance with the Criteria for the Review of Instructed Drugs. The criteria not only regulated the active ingredients， dosage forms， indications， usage and dosage， side effects， matters needing attention and warnings of instructed drugs， but also stipulated the requirements for labeling， instructions and outer-of-the-box printing of instructed drugs. Taiwan area had also established a mechanism for evaluating drug conversion to expand the variety range of prescription drugs converted to OTC drugs， and had equipped a series of supporting measures to reduce the safety risks arising from drug conversion. In 2016， Taiwan area also formulated the Format and Relevant Standards for Outer-of-the-Box of Generic Western OCT Drug， and revised the drug instructions and the outer-of-the-box. The format was more standardized and the terminology was easier to understand， which made it easier for the public to read. It is suggested that mainland China should refer to the experience of Taiwan area， set up special registration channels for OTC drugs and simplify the requirements for examination and approval， pay attention to and improve the matching measures for the conversion of prescription drugs to OTC drugs， encourage brand building and improve intelligibility of OTC drug instructions， so as to build an effective OTC drug management system.