Discussion on the technical requirements and pathways for the marketing of traditional Chinese medicine over-the-counter drugs
The"Measures for the Administration of Drug Registration"stipulate the implementation of classified registration and conversion management for prescription drugs and over-the-counter drugs,and stipulate the development of technical guidelines and procedures for the marketing registration of traditional Chinese medicine over-the-counter drugs based on the characteristics of over-the-counter drugs.At present,China has established a relatively systematic management system for converting traditional Chinese medicine prescription drugs to over-the-counter drugs after they are launched,relying on the Center for Drug Evaluation and the Center for Drug Reevaluation,NMPA.Some experts and scholars have explored the technical requirements and procedures for the registration of traditional Chinese medicine over-the-counter drugs from different perspectives,drawing on domestic and foreign experiences.There are many similarities between health food and traditional Chinese medicine over-the-counter drugs in terms of formula/prescription composition,basic requirements,etc.This article is based on the marketing management system of health food and the research of some experts and scholars on the management of traditional Chinese medicine over-the-counter drugs.From the perspectives of understanding the relationship between traditional Chinese medicine over-the-counter drugs and health food,the marketing monograph path of traditional Chinese medicine over-the-counter drugs,and the registration path of traditional Chinese medicine over-the-counter drugs,it explored the technical requirements and procedures for the marketing of traditional Chinese medicine over-the-counter drugs in China.On the one hand,we can draw on relevant domestic and foreign experiences to further optimize and improve the existing paths for post market conversion,and on the other hand,we can draw on the experience of health food marketing management to study and develop technical requirements for the review of traditional Chinese medicine over-the-counter drugs.When conditions are ripe,the feasibility of developing a monograph on over-the-counter traditional Chinese medicine can be explored.It is hoped that this article can provide some references for the development of technical guidelines and procedures related to traditional Chinese medicine over-the-counter drugs.
traditional Chinese medicine over-the-counter drugshealth foodtechnical requirementslisting path