Japan has started a consultation period on ways to reduce delays in the regulatory review of news pharmaceutical drugs, which includes improving communication between sponsors and regulators on the findings of clinical trials.
An expert panel convened by Japan’s Ministry of Health, Labor and Welfare (MHLW) is also looking at the way drug applications are reviewed by the Pharmaceutical and Medical Device Agency.
On average the delay between a drug being launched in its first market worldwide and Japan is around 1,400 says, more than double the delay for the USA and the UK, and 50% longer than in France.
One of the primary reasons for the sluggish progress is the amount of time it takes to carry out clinical research in Japan – something that is already being addressed by the MHLW via a new three-year programme aimed at encouraging more doctors to participate in clinical trials, providing incentives for patients to enrol in them and increasing the number of centres that operate in accordance with Good Clinical Practice (GCP) principles.
Japan’s Minister of Health, Hakuo Yanagisawa, said the time spent by the PMDA on reviewing drugs is actually not that dissimilar to other regulatory authorities around the world, including the US Food and Drug Administration (FDA).
Rather, the main bottlenecks are the time it takes for sponsors to respond to queries raised by the PMDA, the discussion process between sponsor and regulator in agreeing the analysis and interpretation of data, and the fact that in some cases additional trials are required that add dramatically to the overall review time.
However, he conceded that the number of reviewers in Japan lagged behind the FDA and other regulatory bodies – at round 180 versus more than 2,000 at the FDA – and promised this would be looked into by the panel.