Regulatory reforms for global drug research bode well for Japan’s trial sector
Japan is positioned to grow in the increasingly globalized clinical trial market thanks to decades of gradual regulatory reforms according to new analysis.
The analysis – available here – sought to predict Japan’s role in multi-center clinical trials by looking back at how the sector has developed over the past three decades. The researchers cite 1997 as a pivotal year.
“The implementation in Japan in 1997 of the GCP guideline ICH E6, known in Japan as the new GCP, has had a considerable and almost, revolutionary effect on the Japanese regulatory environment” they write, explaining that is allowed CROs to take over responsibility for Phase II and III clinical trials.
ICH guideline E5 - the ethnicity guideline – has also been one of the most influential guidelines of the past few years in Japan.
In Japan, E5 has had a positive impact according to the authors, who write “this guideline has been successful in reducing the necessity to reproduce clinical research programs in Japan for drugs that have already been approved in the west.”
Market opportunities
Looking forward, the researchers predict that Japan’s clinical trial sector will grow as multi-center, multi-country research continues to become more popular.
“The future of drug development lies in its globalization. Large pharmaceutical corporations have started to conduct multinational phase 3 trials involving Western and Japanese sites, leading to global simultaneous submission to the main regulatory authorities of the World.”
The researchers predict this trend is likely to accelerate as a result of further harmonization efforts such as the adoption of a common technical document (CTD) framework for electronic submissions.
“Global submission and approval will bring the products to the main pharmaceutical markets quicker, to the benefit, of the industry and patients. These strategies must be taken into account as early as possible in the drug development process.”
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