Overcoming Delayed Regulatory Registration
The Importance of In-market Support and Cultural Strategies
Location: Japan
The Challenge
Our client – a European pharmaceutical multinational, had experienced a three-year registration delay for their new drug application and did not understand the cause. As a result, confidence in their Japanese distributor and their clinical trial investigator had eroded, and they were concerned about the risk of further delays which would impact market success.
Identifying the Cause: Cultural Misalignment
In conjunction with our in-market Japanese partner, we conducted careful discussions with each stakeholder to establish the underlying cause of the delay.
The main issue stemmed from various cultural misunderstandings between the parties, creating a breakdown in communication and interpretation during the development of regulatory strategy, and the clinical trial process.
Our Strategy: Bridging the Communication Gap
Outcome - NDA Registration Alignment
With a new governance framework, our client experienced a dramatic improvement in their partner relationships, eliminating mistrust and delays caused by previous misunderstandings.
Now with improved risk mitigation and a revised registration timeline, the client can influence the preparation and strategy of the NDA (New Drug Application) registration process, using the best global evidence to support local trial data.
Success in Japan
For pharmaceutical companies, the Japanese market is extremely attractive, however NDA registration is complex. One of the biggest challenges foreign companies face when meeting Japan’s registration requirements is communication. Cultural and technical understanding as well as an on-the-ground partner support is critical.