浅议中药非处方药上市技术要求和路径
Discussion on the technical requirements and pathways for the marketing of traditional Chinese medicine over-the-counter drugs
蔡铁全 1王进博1
作者信息
- 1. 国家中药品种保护审评委员会,北京 100070
- 折叠
摘要
《药品注册管理办法》规定处方药和非处方药实行分类注册和转换管理,并规定了根据非处方药特点,制定中药非处方药上市注册相关技术指导原则和程序.目前我国依托国家药品监督管理局药品审评中心和药品评价中心,已经建立了较为系统的中药处方药上市后转换为非处方药的管理体系.部分专家学者借鉴国内外经验,从不同角度对中药非处方药上市注册技术要求和程序进行了探讨.保健食品与中药非处方药在配方/处方组成及基本要求等方面有诸多相似之处,本文基于保健食品上市管理制度和专家学者对中药非处方药管理的研究,从对中药非处方药与保健食品关系的认识、中药非处方药上市专论路径、中药非处方药上市注册路径等方面,对我国中药非处方药上市技术要求和程序进行探讨,提出我国一方面可借鉴国内外相关经验,进一步优化完善上市后转换等现有路径;另一方面可借鉴保健食品上市管理经验,研究制定中药非处方药审评技术要求.待条件成熟时,探讨制定中药非处方药专论的可行性,以期对中药非处方药相关技术指导原则和程序的制定提供一定参考.
Abstract
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.
关键词
中药非处方药/保健食品/技术要求/上市路径Key words
traditional Chinese medicine over-the-counter drugs/health food/technical requirements/listing path引用本文复制引用
出版年
2024
NETL
NSTL
万方数据