Every overseas manufacturer considering the Japanese market eventually runs into the same structural wall. An overseas corporation cannot obtain a Japanese marketing authorization in its own name. This is not a matter of product strength or capital. It is how the system is designed.

Why it cannot be obtained

A marketing authorization holder carries responsibility for recalls, reporting and safety measures for products that have entered Japanese distribution. When a health problem arises, the regulator must have a party it can instruct immediately. A corporation with no base inside Japan is not considered able to discharge that responsibility.

In other words this is not a barrier erected to keep foreign products out. It is a mechanism for fixing where responsibility sits — inside Japan. Read that way, the arrangement described below makes sense.

The Designated MAH (DMAH)

Japanese law does not close the route to approval for overseas manufacturers. A system called foreign special approval allows the overseas manufacturer itself to become the approval holder. There is one condition.

Before filing, the manufacturer must designate one company that already holds a Japanese marketing authorization to carry responsibility in Japan. This company is the Designated Marketing Authorization Holder, generally abbreviated DMAH (選任製造販売業者).

  1. The overseas manufacturer selects a DMAH from among holders of a Japanese marketing authorization
  2. The overseas manufacturer files for approval with the Ministry of Health, Labour and Welfare
  3. Following review, foreign special approval is granted to the overseas manufacturer
  4. The DMAH distributes the product in Japan as the domestic responsible party

The approval belongs to the overseas manufacturer; responsibility inside Japan belongs to the designated company. That separation is the essence of the system.

The manufacturing site needs accreditation too

There is a second requirement that is easily missed. An overseas site manufacturing drugs or quasi-drugs for export to Japan must hold accreditation as a foreign manufacturer (医薬品等外国製造業者の認定, Article 13-3).

This accreditation is a precondition for obtaining marketing approval. Without an accredited site, the approval itself cannot be granted.

Projects sequenced as “settle the sales channel first, then prepare the factory paperwork” stop at this point. Whether the manufacturing site meets the requirements should be checked in parallel with commercial discussions — preferably before them.

How to choose whom to designate

A DMAH is not a name on a document. It is the party that actually bears responsibility inside Japan, which is why companies asked to take the role conduct their own due diligence. From the overseas manufacturer’s side, the following are the practical criteria.

  • Whether the company’s marketing authorization is Type 1 or Type 2 (the range of drugs differs)
  • Whether its safety and quality management systems (GVP, GQP) can accommodate the product concerned
  • Whether it can actually execute a recall if one becomes necessary
  • Who will handle distribution — a DMAH does not necessarily hold wholesale capability

The last point is where overseas manufacturers most often encounter unplanned burden. If the company bearing responsibility and the company supplying pharmacies and hospitals are different, both contracts and logistics run on two tracks.

Re-ordering the plan around the system

Market-entry planning usually begins with “where do we sell”. For pharmaceuticals, nothing can proceed until the responsibility structure is settled.

  1. Establish whether the product is classified as a drug in Japan
  2. If so, identify the approval route (new drug, generic, OTC)
  3. Approach candidate DMAHs and confirm whether they will accept the role
  4. Check the accreditation status of the manufacturing site
  5. Secure a licensed distributor

Taken in this order, a premise that turns out to be wrong costs little to correct. Taken in reverse, discovering it late means rebuilding the entire plan.

INCAPE holds a wholesale distribution license for pharmaceuticals and can act as the distributing party in Japan. We advise on product classification, on the combination of licences required, and on how to structure the arrangement.