Easing Market Entry: Japan’s PMDA Allows Approval Filings In English

Japan has decided to expand its language capability to encourage foreign firms to enter its pharmaceutical market.

The country’s Ministry of Health, Labour and Welfare (MHLW) announced on 6 September that it now allows documents in the English for approval filings in order to ease the application process for non-Japanese firms under certain conditions.

For non-Japanese pharmaceutical firms without any offices or branches in the country, the MHLW allows all documents for approval filing to be submitted in English, including the Common Technical Document (CTD) and products’ inserts “for a certain period of time,” the ministry said.

English applications will be acceptable for three categories of drugs: drugs containing a new active ingredient, new combination prescription drugs, and drugs with a new route of administration.

Any firm planning to submit approval documents in English must consult the Office of Review Management at Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), the MHLW added.

The ministry said expanding the allowance for English language documents was a “trial attempt” for an undecided time to address the so-called drug gap between Japan and the global market.

Japan officially processes legal/bureaucratic documents only in Japanese because it is the only official language. 

Since 2001, the ministry has allowed CTD modules 3, 4, and 5 to be submitted in English. However, to address the language barrier and encourage more innovative foreign products to enter the Japanese market, the country’s MHLW issued several notices in English while establishing the first PMDA foreign offices in Washington D.C. and Bangkok, Thailand.

While the PMDA Bangkok office is aimed at expanding its collaboration with ASEAN authorities, the D.C. office is designed to accept consultations from US firms for free and in English to encourage their entry into the Japanese market.

To fill the drug gap, the MHLW has implemented multiple measures, including a waiver of Japanese Phase I studies at the end of 2023, which seemingly attracted more Chinese firms’ global Phase III trials into the country. (Also see "Japan Planning To Expand Phase I Waivers" - Pink Sheet, 5 Oct, 2023.) and (Also see "Multiple Chinese Firms Expand Global Phase III Trials To Japan" - Scrip, 4 Sep, 2024.)

The ministry is also planning to claim a JPY270m ($1.9m) budget next year to build a one-stop consultation counter to help non-Japanese pharmaceutical firms and startups identify Japanese sites for their clinical trials. The counter is expected to operate under the National Centers for Advanced and Specialized Medicine in Japan (NC). 

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