TOKYO – Japan is reaching out to drug developers from around the world to attract more innovative products and emerge as a regional leader in the field.
A conference in Tokyo by the Ministry of Health, Labor and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) was an example of this new type of international outreach. This type of effort is likely to intensify going forward.
"The object of our international regulatory harmonization strategy is to proactively contribute to the international regulatory harmonization and cooperation by disseminating Japan's knowledge on regulations to the world," said Yuji Kanda, director general of the Pharmaceutical and Food Safety Bureau at MHLW. "We aim to resolve the global drug and medical device lag and contribute to global health as well as revitalize the pharmaceutical and medical device industries."
Japan is very competitive globally in terms of its National Health Insurance (NHI) system, its speedy regulatory approvals, medical technology and scientific capabilities. However, as Kanda pointed out, Japan faces a series of challenges such as low incentives for investment in drug development due to the size of the market and the cost of clinical trials. The country also has low capacity in regard to its ability to disseminate information about Japanese regulations while the international systems and links of both the MHLW and PMDA are weak.
In its 2015 International Strategic Plan, the PMDA sets out to better connect Japan with leading regulatory authorities such as the FDA and EMA while also setting a regulatory example for Asian countries such as China and the 10 members of the Association of Southeast Asian Nations (ASEAN) – Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand and Vietnam.
"The concept of the International Strategic Plan is to continue to be a regulatory authority making international contributions while taking the lead in science," said Tatsuya Kondo, chief executive of the PMDA. "We'll promote cooperation and regulatory harmonization with other authorities and contribute to capacity building of the Asian regulatory authorities."
Japan plans to take several steps to become a world reference country. A key step to develop Japan's reliability and attractiveness is to pave the way for more innovative products.
The regulators in Japan introduced the Sakigake Review and Designation System in 2014. The system, which is now being implemented, allows state-of-art medical products to be put into practice first in the country. Medical products that are for the treatment of diseases in dire need of innovative therapies and apply for approval in Japan first or simultaneously with other countries fit into this category. In addition, the products have to show prominent effectiveness in non-clinical study or early phase clinical trials. (See BioWorld Today, April 20, 2015.)
The government also plans to establish an infrastructure for clinical development, the Clinical Innovation Network, which will improve the efficiency of clinical trials by using patients' registered information. MHLW claims this will speed up clinical development in Japan and help expand to overseas markets.
PMDA is also planning to develop a Regulatory Science Center in 2018 to develop new efficacy evaluation indices and techniques to evaluate safety and efficacy. Regulatory science is a big part of PMDA's review system; it represents the integration of knowledge on academic sciences of various fields to decide which products will benefit the public the most. It helps the regulators to come up with evaluation methods for advanced technologies, develop guidelines and set up review standards.
Japanese authorities will distribute more regulatory materials in English. To help other Asian regulators, the PMDA will dispatch liaisons to set up a local collaborative system and give prompt replies to safety measure enquires from other countries. But mostly, PMDA will start the Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs, which will help plan, design and coordinate on-site training for Asian, especially ASEAN countries' regulatory staff.
"In the pharmaceutical area, the short-term goal is to achieve an equivalent position to U.S. and EU in the abbreviated review system of key ASEAN countries," said Kanda. "Mid-to-long-term goal is to promote the global clinical trial and the cooperation in review process."
To continuously push the international communication between Japan and the rest of the world, the MHLW and PMDA will put together a global unit dedicated to taking the leadership in international pharmaceutical and medical device regulatory areas. The new unit in the MHLW will act as a control tower to check up the progress of international strategy and revise those strategies referencing industry opinions and other countries' regulations.