Makoto Nishida, General Manager, Japan
As the world’s third largest pharmaceutical market, Japan is critical for pharmaceutical companies looking to develop and commercialize new medicines. Its advanced healthcare system, strong R&D infrastructure, and supportive regulatory environment present enormous opportunities for drug developers to expand market access while positively impacting public health. Yet entering the Japanese market also presents several cultural challenges and navigating a regulatory process that — if not mitigated prospectively by selecting the right partner — may hinder clinical and commercial success.
Sponsor companies with global aspirations must first understand Japan’s unique regulatory process. The Pharmaceuticals and Medical Devices Agency (PMDA) requires proof that drugs marketed in Japan have been tested in Japanese subjects, with very specific minimum thresholds for Japanese representation in global clinical trials. Additionally, the PMDA also requires drug developers to attend designated consultations with the agency — prior to trial commencement — to ensure that the proposed protocol fulfills requirements and satisfactorily answers regulator concerns.
Don’t go it alone
This consultative process with the PMDA requires patience - with the agency’s experts reviewing the data from the product’s pre-clinical and early-phase safety profile to the eventual post-marketing safety surveillance plan. It is a complex process that is often beyond the in-house capabilities of most Sponsor companies.
A Functional Service Provider (FSP) model can help Sponsor companies that may not have bandwidth or expertise to effectively conduct clinical trials in Japan, tapping into experienced clinical research professionals to help meet their program's objectives, accelerate development, and likely reduce costs. An FSP model can help Sponsor companies enter the Japanese market more efficiently and effectively by providing them with access to a local network of skilled experts and resources. In this model, the FSP acts as an extension of the Sponsor’s team, offering specialized services and support tailored to their specific needs and requirements.
One of the key advantages of the FSP model, when applied to a market like Japan, is its flexibility. Sponsor companies can choose to outsource the entire clinical research process or specific parts of it to the FSP, depending on their requirements and internal capabilities. This allows them to focus on their core competencies while leveraging the FSP's expertise in navigating Japan's complex regulatory landscape and cultural differences without having to build internal infrastructure.
The FSP model also brings cost control and predictability to Sponsor companies. Instead of hiring and maintaining a full team of experts in-house, which can be financially burdensome, they can use the FSP's existing infrastructure and network of experienced professionals. This strategic approach ensures that the Sponsor company pays only for the services they need when they need them, optimizing resource allocation and reducing overhead costs.
Additionally, the FSP model offers access to a wealth of local knowledge and cultural insights, which are crucial for a successful market entry in Japan. Understanding the preferences and expectations of Japanese patients, providers, and regulators is vital for tailoring clinical trials and marketing strategies effectively. By collaborating with an FSP that has a proven track record in the Japanese market, Sponsor companies can navigate cultural nuances and regulatory requirements more adeptly.
A strategic solution
In conclusion, the Functional Service Provider (FSP) model is a strategic solution that empowers Sponsor companies to overcome the challenges of entering the Japanese pharmaceutical market by giving them control yet allowing for local expertise and infrastructure to be utilized. By partnering with an FSP, these companies gain access to a wide range of specialized resources, experience, and knowledge that might otherwise be inaccessible to them. The FSP model's flexibility, cost-effectiveness, and local expertise make it an attractive option for companies with global aspirations, enabling them to focus on innovation and efficiently bring life-saving medicines to the Japanese population.
As Japan continues to play a vital role in the life sciences industry, leveraging the FSP model becomes increasingly crucial for companies seeking to make a meaningful impact on both public health and their own growth prospects.