For global pharmaceutical and biotech companies, entering the Japanese market is not just about getting the product approved—it’s about staying compliant throughout its entire lifecycle. Regulatory success in Japan demands a lifecycle approach that goes beyond initial registration and addresses evolving obligations across pre- and post-approval stages.

One of the most critical post-approval elements is the import license. Even after PMDA approval, a product cannot be commercially distributed without proper import licensing and warehousing contracts. Navigating this process requires deep knowledge of Japanese logistics regulations, documentation requirements, and coordination with the Designated Marketing Authorization Holder (DMAH).

Beyond import readiness, post-approval change management is another critical pillar. Whether it’s a manufacturing site change, product variation, or safety update, these changes must be tracked, assessed, and submitted according to strict timelines set by the PMDA. Failure to comply can delay market availability or trigger re-inspections.

This is where a well-structured DMAH partnership becomes essential. A qualified DMAH doesn't just act as a legal placeholder—it serves as your local compliance backbone, ensuring alignment with evolving regulatory expectations, handling submissions for post-approval variations, managing safety updates, and maintaining your product’s legal presence in Japan.

At Freyr, we support sponsors through a true end-to-end regulatory lifecycle model—from initial dossier compilation and submission (including eCTD and M1 readiness), to import license processing, and long-term post-approval support under our robust DMAH framework.