Foreign manufacturer accreditation in Japan: who needs it

Who needs accreditation, and who files?

Any site outside Japan that manufactures a drug for the Japanese market needs it. That includes a site that makes only the drug substance.

The legal basis is Article 13-3 of the PMD Act (the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices). It is the foreign counterpart of the manufacturing licence that Japanese sites hold. PMDA's English guide for applicants states the API point directly: a manufacturer that makes only drug substances for export to Japan also needs accreditation. If your site supplies an API that a Japanese MAH turns into a tablet in Osaka, your site is in scope.

The Minister grants accreditation. PMDA examines the buildings and facilities (構造設備). Accreditation is given to each manufacturing establishment, not to the company, so a group with three plants serving Japan holds three accreditations.

The applicant is the foreign manufacturer. In practice the paperwork often runs through Japan. PMDA's guide allows a Japanese marketing approval holder that markets your product to file on your behalf, but the applicant's name on the form stays yours. PMDA's step chart for accreditation shows a contract between the Japanese company that files and the foreign site, so agree the terms before anyone files.

Decide early who files for you, because the MAH can do the paperwork, but the accreditation, and the obligation to keep it current, belongs to your site.

What the five categories mean for your site

Accreditation is granted per category. The category follows the kind of work your site does for Japan.

PMDA's category list for drugs (other than in vitro diagnostics), which was written under the former Pharmaceutical Affairs Law, has five categories. The first covers biological products and related products. The second covers radiopharmaceuticals. The third covers sterile drugs. The fourth, usually called the general category, covers all other drugs. The fifth covers sites that only package, label or store. A contract filler that also packs for Japan might hold two: a Vetter press release describes its Japanese accreditation as covering "drug, sterile product" and "drug, packaging, labelling and storage".

The categories matter when work moves. Suppose a Japanese customer wants to shift secondary packaging, or a sterile step, to your site. If your accreditation does not include that category, PMDA's Japanese guidance is clear: changing or adding a category requires the Minister's accreditation. The vehicle is MHLW's Form 21, a separate application for a change or addition of category, not a notification sent after the fact.

The application also asks for a list of every product manufactured at the site as known at the time. Keep that list honest and complete. It describes the whole site, not only the Japanese part of it.

Before a Japanese customer moves a sterile, biological or packaging step to your site, check your accreditation categories, because adding one is a new application to the Minister.

Accreditation and the GMP inspection answer different questions

Accreditation asks whether your site's buildings and facilities are fit for the category. The GMP compliance inspection asks whether manufacturing and quality control for a specific product meet the GMP Ministerial Ordinance (GMP省令).

They differ in almost every respect. Accreditation is held by the site, runs for 5 years and is examined by PMDA on behalf of the Minister. The GMP compliance inspection is applied for by the MAH, follows each product approval, partial change application and five-year cycle, and is described in PMDA's Overview Guidance for Foreign Drugs Manufacturers. A site can be accredited and still fail a product inspection. A good inspection result does not renew an expiring accreditation.

The two meet on paper. MHLW's application form for a GMP compliance inspection of a foreign site has fields for the manufacturer's accreditation category, number and date. An MAH preparing that form needs your number, which is why the request tends to arrive as a filing approaches.

What if accreditation is still pending? The form for regenerative medical products lets an applicant who is still seeking accreditation write the accreditation application's receipt number and date instead. We found no equivalent statement for drugs. Ask the MAH how it will fill that field before you agree a filing date.

The PMDA GMP inspection guide covers the product inspection in detail.

Plan accreditation as the first step of any Japanese supply project, ahead of the MAH's filing, and treat the GMP inspection as a second, separate gate.

What the examination involves

Two applications travel in parallel. One, addressed to the Minister, asks for accreditation. The other, addressed to PMDA's Chief Executive, asks PMDA to examine the site.

PMDA's flow chart then runs in a fixed order. PMDA examines the buildings and facilities, either on documents or on-site. Along the way PMDA can send inquiries, point out problems and ask for replacement pages, and you answer and replace them. The result goes to MHLW, which reviews the accreditation application and issues the certificate (認定証). On-site examinations start with documents submitted in advance and can end with findings for you to answer.

The application package is mostly factual. An MHLW notice of October 24, 2005 on the attachments to the application asks for a list of the products manufactured at the site, as far as they are known when you apply. Where your own authority issues a manufacturing licence, a copy of it goes in the package too. The form also asks for an outline of the buildings and facilities, and site drawings make that outline concrete.

Two items need more thought. The first is the responsible person (責任者). An MHLW notification, available in English translation, says this must be a person with direct responsibility for manufacturing control and quality control at the establishment, and the application includes that person's CV. Pick someone who actually holds that authority, not a regulatory liaison.

The second is your officers. MHLW's April 28, 2021 notice says a physician's medical certificate for officers is not required. It asks instead for a chart of assigned duties (業務分掌表) that separates officers with representative authority from officers in charge of the business without it.

We found no official processing time for accreditation. MHLW's renewal rule, in the next section, is the clearest signal of how much time it expects the process to take.

Name a responsible person who can answer PMDA's questions about manufacturing and quality control without checking with someone else, because that is how the notification defines the role.

Renewal: every five years, filed five months early

Accreditation lapses on its own. If it is not renewed within its 5 years, it loses effect when the period ends.

PMDA's Japanese guidance says so in exactly those terms. MHLW added a practical rule after seeing the same problem repeatedly. Its notice of March 30, 2016 (PSEHB/ELD Notification 0330-4) observed that many renewal applications arrived close to expiry and could not be completed in time. It told prefectures to make sure renewal applications are filed at least 5 months before the end of the validity period.

The same notice explains how PMDA tracks this, and PMDA's FAQ on the list still describes the practice. PMDA publishes a list of accredited and registered foreign manufacturers. An entry appears in yellow when it is past the 5-month point and no renewal has been filed. An entry whose renewal was filed and is still being processed is not yellow, and one whose validity has ended is removed when the list is updated. The list is public, so your Japanese customers can read it.

Between renewals, keep the accreditation accurate. PMDA's e-application manual gives examples of change notifications for foreign manufacturers, including changes of the responsible person, the buildings and facilities, and a category. We found no filing deadline for these notifications in PMDA's materials, so confirm it with PMDA or your MAH.

Put the renewal filing date, 5 months before expiry, in the site's calendar on the day the certificate arrives, not the expiry date.

Steps to get accredited and stay accredited

Take these in order. Steps 1 to 3 decide how fast everything else goes.

1. Map every step your site performs for Japanese products to one of the five categories: biological, radiopharmaceutical, sterile, general, or packaging, labeling and storage. Include steps planned for the next five years.
2. Decide who files. Either your site files directly or a Japanese MAH files on your behalf in your name. Agree in writing who tracks deadlines.
3. Name the responsible person: someone with direct responsibility for manufacturing control and quality control at the site. Prepare that person's CV.
4. Assemble the package: the list of products made at the site, a copy of your local manufacturing licence where your country issues one, an outline of buildings and facilities with drawings, and the chart of officers' duties that separates representative officers from the others.
5. File the accreditation application to the Minister and the examination application to PMDA together, then prepare for either a document or an on-site examination.
6. Send the accreditation number and date to every Japanese MAH that needs it for its GMP inspection application.
7. Set the renewal filing date at 5 months before expiry, check PMDA's list for your entry each year, and file change notifications or category applications before work moves.

The Japanese terms on the forms are in the side box, and more are in the glossary. If your site also registers a drug substance or excipient in Japan's Master File, the MF guide explains the separate in-country caretaker role.