Japan’s New Requirement for Pediatric Drug Development Plans in PMDA Consultations

Introduction to Regulatory Update
According to the news (PMDA　成人対象の治験相談でも「小児用医薬品の開発計画の有無を資料に記載」日薬連等に留意事項通知 | ニュース | ミクスOnline) released by Mixonline on March 29, 2025, the Pharmaceuticals and Medical Devices Agency (PMDA) has notified relevant industry groups that documentation submitted for clinical trial consultations for adult drug development must now include a statement on the presence or absence of pediatric drug development plans. This move aims to encourage early consideration and planning for pediatric indications in Japan, even when the initial focus is on adult patients.

Promoting Early Inclusion of Pediatric Plans
PMDA emphasizes the importance of understanding pediatric development status from the early stages of adult drug development. The new requirement encourages companies to indicate whether they plan to develop pediatric drugs and, if so, to outline which age groups are being targeted and whether the pediatric plan involves joint evaluation with adults or is separate. This visibility allows PMDA to offer guidance proactively and potentially facilitate pediatric development in Japan.

International Coordination for Pediatric Trials
The guidance also suggests that when pediatric clinical trials are planned in the US or EU, Japanese sponsors should aim to participate in global studies from the outset. Early alignment with international development plans is encouraged, which may improve Japan’s inclusion in global pediatric data packages and mitigate the so-called “drug lag” for children.

Support for Drug Lag Reduction and Policy Alignment
This initiative aligns with broader efforts by the Ministry of Health, Labour and Welfare (MHLW) to reduce drug loss and ensure that children in Japan have timely access to innovative therapies. In line with this goal, MHLW is moving to require applicants for new drug approvals to make efforts in formulating pediatric development plans. These updates support a more integrated and forward-looking regulatory approach.

Conclusion
PMDA’s new notification marks a shift in Japan’s regulatory expectations toward more comprehensive lifecycle drug development. By making pediatric development plans a required part of consultation documentation, Japan aims to promote earlier planning, foster international collaboration, and reduce gaps in pediatric drug availability. These actions reflect an evolving regulatory environment designed to ensure equitable access to therapies across age groups