Asian Journal Of Social Pharmacy

Abstract: Objective To analyze the risk control strategy in the research and development of pediatric drugs and to provide references for pharmaceutical enterprises to avoid the risks so that they can produce more and much better drugs for children in China. Methods An expert questionnaire and expert interviews were conducted to identify the specific risks and the key factors, and valuable advices were put forward. Results and Conclusion There are four risk factors in the research and development of pediatric drugs. The first is that parents are concerned and they are unwilling to allow their children to participate in drug trial. Secondly, adult drug safety data cannot support pediatric drug study. Thirdly, pediatric drugs often have adverse events. Last, regulations for pediatric drugs clinical trials are not perfect. Some valuable recommendations are provided to control these risks.

Key words: pharmaceutical enterprise, risk management, pediatric drug, drug research and development