Article | July 9, 2018

PMDA Puts Regulatory Approval On A Fast Track

Source: DIA

By Takao Yamori, ,Executive Director, Pharmaceuticals and Medical Devices Agency, Japan and Sandra Blumenrath, DIA Science Writer

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In recent years, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has taken several steps towards innovating the regulatory process to deliver safer and more effective medicines and devices to patients with life-threatening conditions. Restructuring efforts have targeted the very core of the organization, seeking to improve PMDA’s performance efficiency throughout the regulatory review process.

To that end, PMDA has implemented various innovative, fast-track regulatory initiatives as part of its current 5-year Mid-Term Plan, including the sakigake Designation System and the most recent Conditional Early Approval System.

The result: PMDA scored a major success with the speedy approval of a “titanium bridge” (NPC-17) for type II thyroplasty – a device whose approval would have remained in limbo considerably longer without the sakigake fast-track review system. With the recent regulatory initiatives, PMDA has met the major targets of its Mid-Term Plan, achieving shorter approval times, greater review service quality, and enhanced safety measures. By prioritizing innovative products and companies that have not filed for approval elsewhere, the ministry of health hopes to provide such products earlier to patients.