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Japan Drug Master File

Case Studies

Highlights from ongoing and previous mandates

case study 1

Licensing

Licensing Deal between a large US Biotech and a local Company in Japan

The problem

Finding a suitable local Japanese company to license a large US biotech companies products.

our solution

Yakumed developed a strategy to approach the Japanese market, screened a dozen of local companies based on a systematic analysis of the Japanese market and meetings with potential partners. Finally a couple of companies were shortlisted based on Yakumed’s recommendation. The top company in Yakumed’s list was eventually selected and a deal was signed. The relationship between both companies is excellent and ongoing.

case study 2

Licensing

Out-licensing deal between a European Pharmaceutical company and a Japanese company

The problem

Partner negotiation between a Japanese and European company.

our solution

Yakumed provided a comprehensive strategic assessment to the Japanese market and some of the risks in preparation for the negotiation between two parties. In addition, Yakumed assisted in the face-to-face negotiation with the Japanese partner.

case study 3

Regulatory Affairs

Approval of CMC variation in a Crisis Situation

our solution

Japan was a relatively new market for the US company. A lack of understanding of the requirements was fuelling the confusion and panic within CMC global team. On the other hand, the young CMC responsible in the Japanese affiliate was struggling to convey clearly the expectations of Japanese regulators.
As independent consultants, we stepped in to clarify misconceptions about Japanese CMC requirements with regards to variations. In order to further provide assurances to global CMC team, we conducted industry benchmarking for similar CMC. We have also provided several contingency plans while staying focused on the preparation of high quality responses to Queries from PMDA in order to secure a quick approval. We were successful in obtaining approval without supply issues.

case study 4

Regulatory Affairs

Making sense of Conflicting Information on Regulatory and Drug Development Strategy

The problem

Some European and American Pharmaceutical companies were receiving conflicting information on the Japanese regulatory and clinical development pathways.

our solution

We have carefully assessed each case and provided independent in-depth analyses based on the Japanese regulatory requirements and the scrutiny of precedence in Japan. We have provided a thorough analyses and presented our recommendations. Our detailed assessment reports and follow-up discussions have been useful for these companies to make a decision.

case study 5

CMC Strategy

Formulation Strategy of Investigational Medicinal Product

The problem

An established Pharmaceutical company sought our advice on the CMC formulation strategy for a placebo-control study in Japan.

our solution

Our team provided scientific regulatory evaluation based on the Japanese requirements and the latest technology advances in this area. Our study was backed by a confidential market intelligence of similar cases. Our advice and recommendations helped the company to implement a global strategy, which aligned Japan with EU and US.

case study 6

Orphan Designation

Orphan Designation

The problem

Several companies requested our support to obtain orphan designation in Japan.

our solution

Before any preparation for orphan drug designation, we study each case carefully and assess in a strategy report whether it would be eligible for orphan designation in Japan based on the criteria set by MHLW. We then prepare and submit all the documents needed to MHLW. We arrange and lead the negotiation with MHLW throughout the whole process.