Pediatrics
Initiatives in pediatric medical care
There are not many cases in Japan where drugs approved for use have also obtained pediatric indications. While there are various reasons why the development of pediatric medicines is not progressing, we are advancing pediatric care and drug development with our unique capabilities.
Currently, there are limited medications that have been properly evaluated and have indications for pediatric use. For drugs intended for pediatric use, it is urgent to accumulate information on their use in pediatric populations. It is important to develop pediatric indications in parallel with the development of adult indications.
Moreover, for drugs that are either under review for adult indications or already approved, it is desirable to continue conducting appropriate clinical trials (clinical trials and post-marketing clinical studies) to determine pediatric dosages.
(From the "Guidance on Clinical Trials of Drugs in Pediatric Populations," Notification No. 1334 from the Director of the Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health and Welfare, dated December 15, 2000)
In the United States and Europe, the development of pediatric medications has been legislated, and it is mandatory to consider pediatric development during the development process of adult medications. In contrast, Japan does not have regulations mandating the development of pediatric medications or pediatric formulations, and thus the implementation of pediatric clinical trials has been slow.
Pediatric Trial Experience
Trust from Academia
We also receive many requests for physician-initiated clinical trials and clinical research.
9cases in the last 3 years
Number of medical institutions we deal with 26
Pediatric Exploration Program
This program aims to promote pediatric clinical trials by conducting feasibility surveys on behalf of hospitals nationwide that are capable of conducting such trials.
80 facilities involved
15 times conducted
