Drug Evaluation Committee Information and background necessary for companies to utilize disease registries
Clinical Evaluation Subcommittee
In FY2024 and FY2025, the Clinical Evaluation Subcommittee and the Team for Addressing Ongoing Issues9 have been discussing practical issues and solutions with registry holders with the aim of promoting the use of the registry for drug development. In the course of these discussions, the team focused on an issue upstream in the review process: "When companies consider the use of the registry, they often abandon the idea because they lack sufficient information to make an in-house proposal or to decide whether or not to use the registry.
To address this issue, we identified 24 items of information that companies truly need when making a decision to utilize the technology. In addition, we not only listed the information but also verbalized the background and context of "why companies cannot make decisions without this information.
We hope that this report will help registry holders deepen their understanding of the information disclosure required by companies. We also hope that it will provide an opportunity for registry holders and companies to seek solutions while respecting each other's positions and perspectives, and that it will lead to the establishment of a foundation for appropriate decision-making on opportunities to use the registry.
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee
Clinical Evaluation Subcommittee Continuing Issues Response Team 9
Information and background necessary for companies to utilize disease registries