Applications in English for Japanese companies as well, Keidanren calls for regulatory reform | Yakugyo Nippo – Comprehensive Pharmaceutical Industry News Site

Keidanren published its FY2026 regulatory reform requests, calling for Japanese companies to be included among those eligible to submit CTDs in English for applications for approval of new drugs.

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The story

The Japan Business Federation (Keidanren) published its FY2026 regulatory reform requests on the 15th.

For applications for approval of new drugs, it is calling for eligibility to submit CTDs (Common Technical Documents) in English to be expanded to Japanese companies and other applicants.

At a glance

Publication date and timePublication of FY2026 regulatory reform requests

Purpose of the requestExpand eligibility to Japanese companies for submitting CTDs in English in applications for approval of new drugs

Targeted sectorsRequest to expand CTD eligibility

OrganizationJapan Business Federation (Keidanren)

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