Introduction to FDA's Child-Resistant Packaging Statements in Drug Product Labeling Guidance for Industry
10.7501/j.issn.1674-6376.2017.11.002
- VernacularTitle:FDA药品说明中儿童安全包装描述指导原则介绍
- Author:
lai Hui XIAO
1
Author Information
1. 国家食品药品监督管理总局药品审评中心
- Keywords:
FDA;
labeling;
child-resistant packaging;
statement;
guidance
- From:
Drug Evaluation Research
2017;40(11):1531-1534
- CountryChina
- Language:Chinese
-
Abstract:
FDA issued the Child-Resistant Packaging Statements in Drug Product Labeling Guidance for Industry in August 2017,and mainly introduces the requirements for Child-Resistant Packaging Statements in Labeling,and on carton labeling and container labels.However,there is no similar guidance in our country.This paper introduces the guidance in detail,and expects to arise the attention and provide reference of pharmaceutical companies as well as the enlightenment to the administration of drug administration in China.
