Overview
PDMA’s report, published in Japanese in March and translated into English in April, outlines the need for action. The agency notes “growing concerns about the expansion of drug loss n Japan, where pharmaceuticals approved in the EU and the US are not being developed for Japanese patients.” The problem is particularly challenging for pediatric and orphan drugs, PMDA said.
Introduction
“PMDA has decided to provide essential advice and guidance based on a comprehensive understanding of the overall drug development plan, including the pediatric drug development plan, during its clinical trial consultations and other services,” the agency wrote.
The decision follows talks led by a cross-sectoral project team to address inquiries about pediatric development status. Informed by the team’s focus on regulatory science, PMDA has summarized the basic principles and important considerations for pediatric drug development.
PMDA said it is crucial in Japan to create comprehensive plans that include pediatric drug development and to consider children from the early stages of adult R&D programs. Sponsors should assume Japan’s participation in multi-regional trials starting when pediatric programs are formulated to meet the US and European Union requirements. The exception is when “clear differences in intrinsic or extrinsic ethnic factors are confirmed or anticipated,” PMDA said.
Relevant Information
“Based on these principles, PMDA will, during clinical trial consultations for adult drug development, actively verify the status of pediatric drug development and provide advice or guidance as necessary to ensure that pediatric drug development in Japan is initiated without lagging behind adult drug development,” the agency said.
Starting in Phase II, companies applying to discuss adult clinical trials should factor pediatric studies into their plans. PMDA wants applicants to say whether pediatric programs exist in Japan and overseas in their consultation briefing documents.
Applicants should describe the overall pediatric development plan if their program includes children who can be evaluated alongside adults.PMDA may need to change the basic principles and important considerations. The agency identified talks about revising Japan’s pharmaceutical and medical device regulations as an initiative that could force it to change the document. The talks, which generated a policy document in January, have covered the need to promote pediatric drug development and find solutions for drug loss. Companies seeking authorization for new drugs or indications may be obligated to plan pediatric development.
Conclusion
PMDA’s recent initiatives reflect a growing awareness of Japan’s need to close the gap in access to innovative treatments, particularly for vulnerable populations such as children and patients with rare diseases. By prioritizing pediatric and orphan drug development, the agency is taking meaningful steps to address the country’s increasing drug lag. Continued collaboration between regulators, industry, and international partners will be essential to ensure that Japanese patients benefit from timely access to life-saving therapies.
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