Japan considers adjusting clinical trial requirements to remove the need for local studies — report
Japan is rethinking its clinical trial requirements to address a lag in Japanese approvals for new drugs that are already available in other countries, according to the financial news outlet Nikkei.
In the next few months, the country is expected to lift a rule requiring additional safety studies with Japanese participants before a drug can be marketed, Nikkei reported, citing unnamed sources.
Japan has been grappling with a so-called “drug lag” for decades, in which drugs approved in the US and Europe can take much longer to arrive on the Japanese market for a number of reasons, including clinical trial requirements.
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