Japan Adds New Consultation Categories for Medical Devices

On February 15, 2007 the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan recently drafted a proposal to introduce changes to the current available consultative sessions. The PMDA offers various consultative sessions to help applicants navigate the regulatory process. Some of these are for general, preliminary inquiries, while others are for more specific issues such as local clinical trials. Prices for these sessions vary depending on the nature of the consultation and the timing.

Currently, there are two consultative sessions which cater specifically to clinical trial inquiries. The PMDA proposes to add 11 more consultation categories. One new consultation category, for example, is for cell/tissue based medical products and the documentation required when conducting their clinical trials. Another category is for determining whether existing clinical trials outside Japan would be sufficient for registration or if local clinical trials would be required. For example, such consultations would look at existing foreign clinical data in conjunction with pre-clinical data to assess their sufficiency. This consultation would cost ¥854,100 or roughly $7,316. Many of these new categories are very specific. Government consultation fees range from $5,000 to $8,000.

The PMDA is only adding one additional category for the preliminary, more general consultative sessions. This category is for Good Manufacturing Practice (GMP) / Quality Management Systems (QMS) inquiries. In Japan, QMS is used to refer to GMP for medical devices, while GMP by itself usually refers to drugs. These more general, preliminary consultations usually cost around $200.