Analysis of Foreign Regulatory Policy for Pediatric Research and Development and Application

Abstract

Abstract: Children are in the developmental stages, and there is a big difference between the drugs for children and drugs for adult, so drug safety issues can not be ignored. Our market for drugs in children is not yet mature, and there are not relevant regulations and policies to specifically guide the drug use in children, which to some extent increases the risk of pediatric drugs. The U.S. and the EU have made great efforts in this regard, established the pediatric exclusive system to encourage enterprises to conduct pediatric research. Japan, WHO and other regions developed appropriate measures to promote the development of pediatric drug research and supervision. Based on the literatures home and abroad, we analyzed the regulatory policies for the research and development and application of pediatric drugs in U. S. and EU in order to provide recommendations for our drug policy.

Key words: foreign, pediatric drugs, research and development, supervision and regulation, policies

CLC Number:

R951

LU Yu-mei . Analysis of Foreign Regulatory Policy for Pediatric Research and Development and Application [J]. Chinese Journal of Pharmacovigilance, 2013, 10(9): 527-532.

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