P319: Exploring the Impact of Regulatory Convergence to Patients: Japan’s Case for Participating in FDA’s Project Orbis
Poster Presenter
Yuki Miyatake
Sr Group Manager
Eli Lilly and Company Japan
Objectives
The objective is to explore the impact of regulatory convergence for patients by analyzing a case of country not participating in Regulatory Collaborative Models vs country organizing the models, namely the existing approval gaps between products in Japan and products in FDA’s Project Orbis program.
Method
For this study, we reviewed the approval lists of medicines and published articles published by FDA and Pharmaceutical and Medical Device Agency (PMDA), Japan’s regulatory agency, to compare approval timeline gap between FDA’s approvals through Project Orbis and Japan’s approvals.
Results
From 2019 to 2024, we confirmed that there were 36 New Molecule Entities (NMEs) approved by FDA through Project Orbis based on the list published by FDA’s OCE. One third (or 12) NMEs were developed by companies founded after 1990, most of the companies which had not directly entered the Japanese market during this timeframe. Additionally, most of the medicines approved through Project Orbis had not been approved in Japan as of Oct 31st, 2024.
Conclusion
Regulatory Collaborative Models can accelerate delivery of innovative medicines to patients around the world by contributing more cohesive regulatory reviews. Beyond the adoption of internationally harmonized guidelines, boldly creating more regulatory reliance pathways to review and approve new medicines across the globe would be beneficial to global health. International collaborative reviews, such as FDA’s Project Orbis, are powerful and impactful ways to achieve such regulatory convergence.
While Japan is one of the largest markets in the pharmaceutical industry, it currently faces difficulties in attracting emerging start-up companies and biopharmaceuticals. Japan’s Ministry of Health, Labour, and Welfare (MHLW) and PMDA are actively reforming their regulations in order to eliminate the so-called “drug lag” or “drug loss”.
Our analysis in this study suggests that recent oncology medicines approved in the US through FDA’s Project Orbis have not been approved in Japan simultaneously (“lag”) or at all (“loss”). In other words, if Japan had initially participated in Project Orbis fully, those medicines would likely have been available to patients much earlier in Japan. Japan’s enhanced participation in regulatory convergence and regulatory collaborative programs could be a possible avenue toward the goal. This would result in for any countries seeking to of ensuring access to innovative medicines greater and earlier.
