Comparison of the regulation of pediatric drugs research and development at home and abroad
10.13220/j.cnki.jipr.2016.04.003
- Author:
Ya-Hui ZHANG
1
Author Information
1. Shandong Provincial Hospital Affiliated to Shandong University
- Publication Type:Journal Article
- Keywords:
Clinical trials of medicines;
Pediatric drugs;
Pediatric exclusivity;
Research and development;
Supervision and regulation
- From:
Journal of International Pharmaceutical Research
2016;43(4):591-596
- CountryChina
- Language:Chinese
-
Abstract:
The problem of pediatric drugs has been the challenges facing the world. The two most important issues are the lack of appropriate drug dosage forms for children and the safety and effectiveness data of drug use in children. How to encourage production enterprises to produce drug varieties, specifications and dosage forms suitable for children use, guide drug manufacturers to obtain drug use data are the most important work for pediatric drugs.Based on the literature home and abroad, we analyze the regulatory policies for the research and development(RD) and application of pediatric drugs in the USA, EU and Japan, which have made great efforts to encourage enterprises to conduct pediatric research. Their successful experiences are summarized and can be used as reference for the establishment of the policies adaptive to the situation of China for the RD of pediatric drugs.
