Japan continues to be the third largest pharmaceutical market in the world. According to the Ministry of Health, Labor and Welfare (MHLW)’s Annual Pharmaceutical Production Statistics, the Japanese market for pharmaceuticals in 2020 was $109 billion. Despite projections estimating limited growth in the coming years and government policies to contain healthcare expenditure, the market is expected to remain the third largest globally, and one of the most important destinations for foreign biopharmaceutical companies due to continued demands for innovative therapies.
In terms of drug development, Japan is an excellent candidate for conducting clinical trials, with strong infrastructure, top professionals, and a universal healthcare system. In recent years, the country has shown significant progress in terms of optimizing the approval of new therapies, achieving similar timelines to the FDA’s or EMA’s and promoting incentives to prioritize the development of new therapies focused on unmet medical needs, such as the Conditional Early Approval System. This pathway speeds up the practical application of drugs that target serious, debilitating diseases, allowing early applications to be admitted without confirmatory clinical trials, on the condition that the product’s safety and efficacy be further evaluated while on the market.
When designing and executing clinical trials in Japan, it is essential to understand the nuances of the environment as well as to partner with local experts able to provide the right guidance and network to optimize timing and costs of Japanese clinical trials.
Here are some of the most relevant keys to ensure the success of clinical trials in Japan:
- Deep knowledge of local regulations: Understanding Japan-specific clinical trial regulations and guidelines is critical to circumvent potential hurdles and ensure a time- and cost-optimized approval. Establishing open and regular communication with the Pharmaceuticals and Medical Devices Agency (PMDA) and other regulatory authorities is essential for a smooth review and approval of the clinical trial. An experienced Japanese CRO, such as Linical, can help in navigating this process. It is also necessary to keep abreast of regulatory updates as these may affect the initial development plans, and the ability to adjust the trial design and processes accordingly are critical to avoid delays or cost overruns.
- Support from local experts: For an adequate development of the study, it has to be handled by professionals experienced in collaborating with reputable hospitals and medical centers, with strong relationships with investigators, physicians, and collaborators who can facilitate recruitment and proper protocol compliance. It is also vital to ensure that all trial materials are properly translated into Japanese and are culturally appropriate for the understanding and participation of Japanese patients. CROs in Japan will also have the expertise to ensure adequate compliance with local regulatory requirements while following international quality standards and maintaining rigorous data management.
- Designing a specific recruitment strategy: Recruitment is one of the biggest challenges to be faced when conducting a clinical trial in Japan, so it will be necessary to design a strategy taking into account not only the guidelines defined in the protocol but also the current clinical trial regulations in place, as well as the needs and particularities of the local patient population. In this sense, in addition to advertising or awareness campaigns, developing tailor-made initiatives and having good relationships with key sites and strong bonds with investigators and personnel will be decisive to ensure recruitment.
- Cost management: Compared to other countries in the region, the costs associated with the development of a clinical trial in Japan are usually higher due, among other reasons, to the greater need for face-to-face communications with the personnel involved in the study or the complexity of the payment systems. Thus, it is essential to have a partner with the necessary knowledge to propose strategies that optimize costs at the level of recruitment, regulatory costs, contracts, negotiations with sites or management of supply related costs.
- Communication and cultural considerations: For clinical trials in Japan, proper communication, and knowledge of and respect for the local culture and customs can be key to ensuring the smooth conduct of the project. Thus, to avoid delays in recruitment or other problems, it is very important to have a Japanese CRO partner with expertise in cross-cultural communication who can maintain effective communication with both the sites and the sponsor, conveying the same message to all stakeholders in the most appropriate communication style.
Originally established in Japan, Linical is global Contract Research Organization (CRO) for full-service drug development with the experience, resources, and know-how to successfully conducting clinical trials in Japan. Our team of local experts possess deep, local regulatory knowledge and excellent relationship with sites, KOLs and PIs, will provide guidance and the best solutions to avoid obstacles and ensure the success of your clinical studies in Japan.
Linical provides a full spectrum of drug development services from early stage to large-scale, multinational studies. Our areas of focus include Phase I-IV studies in oncology, neurology & psychiatry, immunology & vaccine, and endocrinology & metabolic diseases.
We can provide comprehensive support to biotech and pharma companies from the earliest phase of development, not only proving full-service drug development services but also supporting companies interested in entering the Japanese market but unfamiliar with its regulations. We can support organizations in terms of market access, development & regulatory strategy, PMDA Consultation or medical writing as well as in the process of looking for partners or licensing. Linical is your gateway to the Japanese market.