Submitting clinical data to the FDA and PDMA: An efficient and compliant approach

In both the US and Japan, regulators provide an extensive set of resources detailing the rules and specifications governing submissions for marketing approval of new drugs and biologics. Fortunately, despite some differences, the regulations concerning clinical data have a surprising amount in common. It is possible that with a solid understanding of the requirements and an adherence to best practices, sponsors can develop some of the same material for submission to both countries.

- Kent Letourneau, Executive Director, Global Data Standards, ICON, USA Sandra Minjoe, Senior Principal, Clinical Data Standards, ICON, USA

Accessing technical references

The US Food and Drug Administration (FDA) and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan each maintain a comprehensive website of study standards with links to important documents for study sponsors. Notably, both agencies offer a searchable Data Standards Catalog to aid sponsors in finding only those standards and the correct versions that are applicable to a given study. Both also have published a Technical Conformance Guide, following a similar format.

In the US, sponsors should refer to two binding guidances: FDA Guidance for Industry: Providing Regulatory Submissions in Electronic Format—Submissions Under Section 745A(a) of the Federal Food, Drug & Cosmetic Act; FDA Providing Regulatory Submissions in Electronic Format-Standardized Study Data (June 2021).

The PDMA’s guidance is laid out in Notification on Handling Submission of Electronic Study Data for New Drug Applications.

Selecting the appropriate standard