Japan: PMDA to Increase Regulatory Strategy Consulting Sessions

Starting next year, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) will increase its capacity to provide medical companies with face-to-face regulatory strategy consulting. As of September 2012, the PMDA has handled about 50 face-to-face pre-consultation sessions per year, and it intends to increase that number to about 130 by 2015. Besides increasing the quantity of these consulting sessions, quality is also a target, as the PMDA aims to provide more detailed follow-up discussions depending on the complexity of the issue.

The PMDA started regulatory strategy consultations in 2011, initially targeting universities, research institutes, and entrepreneurial companies with innovative pharmaceutical and medical technologies. Some of these consultation sessions were with foreign companies. With increasing demand and improving technology, the PMDA expects it will have more cases to handle, hence the push for more face-to-face consultation to help domestic and foreign medical manufacturers better understand the key regulatory issues in Japan.