Japan Regulatory Update: More In-Depth Data Demands; Single-Audit Participation

Japan's regulatory authority plans to establish a new Regulatory Science Centre in the next three years, which will be tasked with reviewing more in-depth data to support product approvals. Also, the country is now a full participant in the Medical Device Single Audit Program.

Medical device and drug companies will be required to submit more in-depth data to get product approval in Japan, as the country’s Pharmaceuticals and Medical Devices Agency looks to introduce "advanced" product evaluations within the next several years.

The effort would be run by a new Regulatory Science Centre that will be established within PMDA to support product reviews. RSC would be tasked with applying advanced regulatory science...

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