Japan's new drug approvals always a step behind? A fix may be coming

Reprinted with permission: Pharma Statistical Insights

According to a report by the financial news outlet Nikkei, Japan is rethinking its clinical trial requirements for drugs in order to address delays in approving new medicines already launched in other countries.

The report says that in the coming months, Japan is expected to drop the pre-launch requirement for manufacturers to conduct additional safety studies involving Japanese participants.

For decades, Japan has struggled with the so-called "drug lag" — drugs approved in the US and Europe taking longer to reach the Japanese market for a variety of reasons, including clinical trial requirements.

Between 2017 and 2022, one study found, the median time for a new cancer drug to be approved in Japan after US approval was 4.2 years.

Research in Drug Discovery Today indicates this lag hits patients with rare cancers especially hard, even though Japan's health authorities have taken steps to address the issue, including expanding the number of reviewers.

The controversy over how to accept data from overseas new drugs is not limited to Japan. Last year, the US FDA rejected several applications for new cancer drug approvals based solely on clinical study data from China, sparking considerable tension at the time.

As US regulators put it: Richard Pazdur, director of the FDA's oncology center, wrote in The Lancet last year that "the trials conducted in China used control arms that did not meet current US standards, and the treatments the control groups received had already been superseded by more advanced drugs in the US, making patient recruitment for trials more difficult."

Pazdur added that the real bridge across the difficulties of coordinating global drug development and regulators would be multiregional clinical trials, not single-country studies.

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