PMDA Outlines Initiatives to Promote Pediatric Drug Development in Japan

PMDA Outlines Initiatives to Promote Pediatric Drug Development in Japan

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.

Supporting the Development of Regenerative Medical Products for Rare Diseases

Supporting the Development of Regenerative Medical Products for Rare Diseases

Japan, the Orphan Drug Designation (ODD) system is designed to promote the development of treatments for rare diseases, including regenerative medical products. Regenerative medical products, which encompass therapies aimed at repairing or replacing damaged tissues or organs, can qualify for ODD if they meet specific criteria.

Japan’s Orphan Drug Designation System: Advancing Medical Technologies for Rare Diseases

Japan's Orphan Drug Designation System: Advancing Medical Technologies for Rare Diseases

In Japan, the Orphan Drug Designation (ODD) system is a pivotal regulatory framework designed to encourage the development of medical devices targeting rare diseases. This initiative aims to address unmet medical needs by providing various incentives to manufacturers, ensuring that patients with rare conditions have access to essential medical technologies.