Japan's PMDA sets 12-month target on drug, device reviews with domestics favored

Japan's Pharmaceuticals and Medical Devices Agency (PMDA) aims to accelerate high-quality drug and medical device reviews to 12 months for at least 70% of new drugs filed for approval with domestic firms favored, according to its steering committee meeting on March 10.

The target is for the fiscal year starting April 1, and would compare to a 60% target this year and place PMDA on a path to raise the level to 80% for both products by fiscal 2018.

The committee said it remains committed to international regulatory harmonization, strengthened capabilities to deliver information, and working with academia.

But the PMDA plans to introduce what is called the "sakigake designation system" to expedite the review of innovative drugs developed in Japan earlier than the rest of the world.

This includes prioritized consultations and priority review status.

The PMDA also said it would renew its safety focus with the rollout of an online system to directly accept adverse reaction reports from patients, which is currently running on a trial basis.

The trial system began in March 2012 and allows patients, or relatives, to report an ADR. The system showed a spike in reports of adverse reactions to human papilloma virus (HPV) vaccines between April 2013 and March 2014 compared to the previous year, coinciding with a health ministry plan to stop active promotion of vaccinations against HPV.

The PMDA also intends to draw up a new plan to further reinforce its collaboration with overseas regulatory authorities, with calls from multinational firms seeking greater interaction with U.S. and European counterparts.

The agency also said that from Oct. 1 next year it would ask drug makers to file clinical data for their new drug applications based on Clinical Data Interchange Standards Consortium (CDISC) formats as mandatory for products filed on or after that date, but would consider a grace period to the end of March 2020.

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