OBJECTIVE: To probe into the current status of revision of drug instructions of Chinese traditional patent medicine in China

so as to promote the standardization and rationalization of Chinese traditional patent medicine.METHODS: Relevant laws and regulations of drug instructions in China were reviewed.The announcement on drug instructions of Chinese traditional patent medicine in China published on the website of the State Drug Administration from Mar.2010 to Sept.2019 were collected.Related data of varieties and revision items of Chinese traditional patent medicine were analyzed

and the existing problems in revision of drug instructions of Chinese traditional patent medicine were summarized.RESULTS: In the past 10 years

the State Drug Administration had issued a total of 83 announcements and notices for the revision of drug instructions of Chinese traditional patent medicine

there were 167 varieties of Chinese traditional patent medicine

including 66 kinds of prescription drugs and 101 kinds of over-the-counter drugs.The revision items were mainly taboos

cautions

adverse drug reactions and warning words.However

through daily practice

it was found that there were still some problems in drug instructions of Chinese traditional patent medicine

such as non-standard writing

poor implementation

insufficient supervision and weak binding force of relevant laws and regulations

which had severe impacts on the safety of medication for patients.CONCLUSIONS: The revision of drug instructions of Chinese traditional patent medicine in China still has problems such as missing contents

which need to be further improved.