Japan is one of the world’s most important pharmaceutical markets, but foreign manufacturers cannot access it without first meeting Japan’s regulatory requirements. Besides submitting a Japanese drug registration dossier, clinical trial information, etc., — for drugs or quasi-drugs manufactured overseas, the applicant must obtain formal recognition from the Japanese government. This process is known as Foreign Manufacturer Accreditation (FMA).
What is the Accreditation of Foreign Manufacturers?
Under Article 13-3 of Japan’s Pharmaceuticals and Medical Devices Act, any overseas company or individual intending to manufacture drugs or quasi-drugs for export to Japan must first be recognized as an “Accredited Foreign Manufacturer” by the Minister of Health, Labour and Welfare (MHLW). This can be considered the foreign equivalent of the manufacturing license that Japanese domestic facilities (agents or MAH’s) are required to hold.
This requirement is not limited to finished pharmaceutical products. If a foreign company manufactures only drug substances (i.e., active pharmaceutical ingredients or excipients) that will eventually be used in products exported to Japan, the same accreditation requirement applies. The scope is broad by design to reflect Japan’s commitment to ensuring that any product reaching Japanese consumers meets consistent quality and safety standards, regardless of where it was made.
Who Reviews the Application?
Both the MHLW and the Pharmaceuticals and Medical Devices Agency (PMDA) review the application. The MHLW is the authority that formally grants accreditation. However, it is the PMDA that carries out the technical examination, specifically reviewing the buildings and facilities of the manufacturing establishment. In practice, this means applicants interact primarily with the PMDA throughout the review process, while the MHLW issues the final accreditation certificate based on the PMDA’s findings.
Accreditation is also specific to each facility and category. Each manufacturing establishment must be individually accredited, and the accreditation is tied to the specific product category. If a facility wants to manufacture under multiple categories, separate applications are required for each one, and they cannot be bundled into a single submission. Examples of manufacturing establishments includes facilities for manufacturing, sterilization, storage, etc.
The Application Process
Before submitting an FMA application, the Japanese marketing approval holder associated with the foreign manufacturer must file a “Business Number Registration Form” with PMDA. This form registers key information about the applicant and their manufacturing establishment.
The main accreditation application consists of two parallel submissions, both sent to the Administration Division II of PMDA’s Office of Review Administration. The first is the “Application for Accreditation”, addressed to the Minister of Health, Labour and Welfare. The second is the “Application for Accreditation Examination”, addressed to the PMDA’s Chief Executive.
A Japanese Marketing Approval Holder (MAH) or Designated Marketing Approval Holder (DMAH) is permitted to submit these applications on behalf of the foreign manufacturer, which is common in practice since most foreign companies rely on a local partner to navigate Japanese regulatory filings. However, even when the application is filed by proxy, the “Name of Applicant” field must contain the foreign manufacturer’s name. The foreign manufacturer, not the Japanese partner, bears ultimate responsibility for keeping the accreditation current.
Required Supporting Documents
The documentation requirements are fairly detailed. The core supporting documents are as follows. First, a curriculum vitae (CV) for the person responsible for the manufacturing establishment(s). Second, a product list detailing what will be manufactured for export to Japan. This must be accompanied by documentation explaining the manufacturing process for each listed product. Third, a document describing the buildings and facilities of the manufacturing establishment. This includes floor plans and any other materials the PMDA needs to evaluate the physical setup of the facility.
Additional documents may be required in specific situations. For example, if the country where the foreign manufacturer is located has its own drug manufacturing licensing or approval system, a currently valid copy of that country’s license certificate must be included. This requirement serves as evidence that the manufacturer is in good standing under their home country’s regulatory framework.
As for timelines, the PMDA has not set a formal timeline for the review of FMA applications. However, the FMA timeline for domestic manufacturing establishments is typically around four to five months, and this timeline can be used as a reference point.
Renewals, Changes, and Ongoing Obligations
Foreign manufacturer accreditation in Japan is valid for five years. If it is not renewed before the expiration date, it becomes null and void. To renew, manufacturers must submit an “Application for Renewal of Accreditation” (Form No. 20) together with the same accreditation examination form required in the original application.
When a facility’s scope of operations changes, a separate “Application for Change/Addition” (Form No. 21) must be filed. It is worth noting that adding a category and changing a category are two distinct procedures. Adding a category means new categories are layered on top of existing accreditations, which remain in force. Changing a category, on the other hand, cancels the previously accredited categories and replaces them with new ones. In both cases, the accreditation examination form must be submitted alongside the application.
Any of the following changes must be reported to the Minister within 30 days by submitting a notification form to PMDA: a change in the name or address of the person responsible for the manufacturing establishment, a change in the names of corporate executives responsible for operations, a change in the name of the manufacturing establishment itself, major changes to buildings or facilities, and any change in accreditation category or number — including when a manufacturer obtains an additional accreditation or ceases operation of an accredited facility. Failure to keep these notifications up to date can affect the manufacturer’s standing with the Japanese regulators. If a change notification is submitted later than the recommended timeline, an apology letter must be issued.
Key takeaways
Japan’s pharmaceutical market is among the most valuable in the world, and the accreditation process, while demanding, is a well-defined path. Understanding what is required and planning accordingly goes a long way. For manufacturers approaching this for the first time, partnering with a Japanese marketing approval holder who knows the PMDA process well is one of the most effective ways to avoid unnecessary delays.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.