PMDA Launches One-Stop Platform to Ease Overseas Biotech Clinical Trials in Japan

Japan's Pharmaceuticals and Medical Devices Agency (PMDA) is coordinating with other Japanese bodies to offer a one-stop service platform for biotechs that want to run clinical trials in the country. Japan's Ministry of Health, Labour and Welfare (MHLW) has set up ENSEMBLExJ, a one-stop service office that will consult and coordinate to enable companies to run clinical trials in Japan. The country's National Centers will implement the project in collaboration with Clinical Research Core Hospitals.

PMDA will consider providing priority consultations to companies developing candidates that are eligible for ENSEMBLExJ. Eligibility for priority consultation is limited to drug or regenerative medicinal products that address a high medical need and are being considered for clinical development in Japan. PMDA and ENSEMBLExJ will assess medical needs based on existing guidance for handling priority reviews. The organizations will also jointly decide on a case-by-case basis whether companies can submit their consultation documents in English. The English-language submission option is aimed at companies that lack a Japanese subsidiary and meet other criteria, such as having annual global sales of less than $500 million or annual R&D costs of less than $200 million. PMDA is advising companies that want a priority consultation or intend to file English-language paperwork to consult with ENSEMBLExJ in advance.

PMDA has begun courting overseas emerging biotechs in recent years to tackle drug lag and loss, terms for products that either launch in Japan long after other countries or never reach the market. Initiatives like setting up overseas PMDA offices are part of the agency's response to the problem.