Pediatric Drug Development in Japan: A Comparison of the Current Situation and Characteristics Between Japan and Europe.

ABSTRACT

BACKGROUND: In contrast to the European Union and the USA, no laws or regulations mandating pediatric drug development have been established in Japan. Based on the information on drugs approved for pediatric indications in Europe and Japan, we evaluated the recent status of pediatric drug approvals and their characteristics in Japan in comparison with those of Europe. METHODS: Drugs approved for pediatric indications between 2007 and 2015 in both regions were included in the study. The proportion of drugs with pediatric indications was calculated by the Anatomical Therapeutic Chemical (ATC) classification, and the status of pediatric formulation development was examined. The time from adult to pediatric indication approval was determined. RESULTS: A total of 135 drugs were approved for pediatric indications in Europe, with 208 approved in Japan. The proportion of drugs with pediatric indications in Japan among those approved for pediatric indications in Europe was lower among those with ATC classifications of N (Nervous system) and J (Antiinfectives for systemic use) and those with the development of pediatric formulations than among others. Excepting drugs for which adult and pediatric indications were simultaneously approved, the most commonly observed period from the adult indication approval to the pediatric indication approval was more than 12 years in Japan and 3-6 years in Europe. CONCLUSION: The present findings suggested that pediatric development is indeed being promoted in Japan. However, the period from adult to pediatric indication approval was longer in Japan than in Europe, and the development of pediatric drugs for certain diseases has been sluggish, indicating room for further improvement.