Research and practice on readability test of Danshen Capsule for registration as THMPs in EU
10.7501/j.issn.0253-2670.2017.04.032
- Author:
Shan-Shan ZHANG
1
Author Information
1. Shenyang Pharmaceutical University
- Publication Type:Journal Article
- Keywords:
Danshen Capsule;
Drug registration;
EU;
Package leaflet;
Readability test;
Traditional herbal medicinal products
- From:
Chinese Traditional and Herbal Drugs
2017;48(4):843-846
- CountryChina
- Language:Chinese
-
Abstract:
The package leaflet is a legal document relevant with drug information, which plays an important role for instructing the rational use of the medicinal product for the patient population. During the registration application in the EU countries, the patient readability test on package leaflet is the essential requirement to ensure the leaflet information easy-to-understand and avoid any risk caused by misunderstanding. The readability research on package leaflet can improve its quality and drug use safety to patients. Currently, CFDA does not publish any regulation/guidance on the drug application in China. By the successful case of registration application of Danshen Capsule as the herbal medicine in the EU, this paper not only discusses the relevant requirements of readability test in the EU, but also offers the regulatory advice on future regulations of readability research of the pharmaceutical products in China.
