Question 1

How can HekaBio help foreign healthcare companies enter Japan?

Accepted Answer

HekaBio helps overseas healthcare companies assess and execute practical Japan market entry plans. Depending on the asset and project, support may include opportunity assessment, regulatory coordination, market access planning, commercialization strategy, launch preparation, distribution and local commercial operations. HekaBio may become the licensee or distributor partner in some cases, and, in others, will support the selection a of a third3rd-party licensee or distributor partner. The scope is agreed case by case depending on product category, regulatory requirements, development stage and the company’s commercial objectives.

Question 2

What regulatory and commercialization capabilities does HekaBio provide in Japan?

Accepted Answer

HekaBio is fully licensed to obtain and hold regulatory approvals and commercialize assets across pharmaceuticals, medical devices, in vitro diagnostics and regenerative medicine products. HekaBio commercializes assets in its portfolio and offers its services to innovative companies that require a DMAH to launch in Japan.

Question 3

What is a Designated Marketing Authorization Holder, or DMAH, in Japan?

Accepted Answer

A Designated Marketing Authorization Holder, or DMAH, is a licensed Japan-based company appointed by a foreign entity to handle on its behalf the full responsibilities in Japan for its approved product, including regulatory file maintenance, quality and safety management and reporting.

Question 4

Does HekaBio have DMAH experience in Japan?

Accepted Answer

Yes, HekaBio has experience serving as a DMAH in Japan and will consider taking on additional DMAH programs for the right innovation and partner.

Question 5

Why does DMAH experience matter for foreign companies?

Accepted Answer

DMAH experience matters because the role carries practical Japan-based quality, safety and regulatory responsibilities. An experienced organization should be expected to coordinate more effectively with the foreign authorization holder, regulators and local service providers. However, DMAH experience alone is not enough. A company that has acted as DMAH may not have experience with a particular product category or regulatory pathway, so product-specific capability should always be assessed.

Question 6

Does working with HekaBio mean a company does not need a Japanese subsidiary?

Accepted Answer

Yes. HekaBio may become a foreign company’s licensee or distributor partner, help that company find another licensee or distributor partner or act as its DMAH, supporting a flexible structure. Neither of those scenarios requires the company to create a Japanese subsidiary. Also, the company is also not prevented from establishing or setting up a subsidiary. For example, HekaBio can serve as the company’s DMAH to handle statutory requirements while its Japanese, and the company can set up a Japan subsidiary initially to focus on sales and marketing, with the option of at first and taking over the DMAH role over time.

Question 7

How is HekaBio different from a consultancy?

Accepted Answer

HekaBio is an operating company whose primary role is in-licensing and growing commercial sales of its own portfolio. Utilizing its experience and contacts, HekaBio is also well positioned to offer hands-on support for licensing to 3rd parties in Japan. Additionally, HekaBio’s infrastructure and licenses enable it to offer a ready-made platform for commercialization as a DMAH. HekaBio is not a consultancy, but part of its activities overlap with what consultants do.

Question 8

Can HekaBio support companies before product approval?

Accepted Answer

Yes. HekaBio reviews the assets that come to it and hopes to provide helpful input to the product innovators, whether or not the product is in its own target area. HekaBio can support companies by assessing the Japan opportunity, regulatory pathway, evidence requirements, reimbursement opportunity and commercial model. Early work can help connect Japan requirements with global development plans and preserve strategic flexibility.

Question 9

What HekaBio capabilities should be confirmed before publication?

Accepted Answer

Before publication, HekaBio should confirm all statements about its licenses, authorizations, DMAH role, quality and safety responsibilities, product-category capabilities and experience with named products. The wording should be current, specific and consistent with the actual legal and operational scope. Regulatory, quality and legal review is particularly important where a statement could imply responsibility for approval, post-market obligations or regulated services.

FAQ