Japan Issues Minor Changes to FMA Application

On October 8, 2010, the Pharmaceuticals and Medical Device Agency (PMDA) of Japan’s Ministry of Health, Labour and Welfare (MHLW) released Notification 1008 No. 1.

With this notification, marketing authorization holders (MAHs) who are involved in the foreign manufacturer accreditation (FMA) process must become more aware of the foreign manufacturer’s other MAHs and products. In the revised FMA application, the “Product and Process List” Form requires details on all of the foreign manufacturer’s products in Japan and the products’ corresponding MAH.

This notification also included updates on the medical certificate requirement for the foreign manufacturer’s representatives involved in the manufacturing process. In the previous FMA application guidelines, a medical certificate from the manufacturing site’s country was required for each company representative involved in the manufacturing process. More recently, a change was implemented where under “unavoidable” and “reasonable” circumstances, the medical certificate could be substituted with a signed and written statement. Now with Notification 1008 No.1, under “unavoidable” and “reasonable” circumstances, a single representative for the foreign manufacturer who agrees to assume responsibility may submit a single signed and written statement. This single signed and written statement would replace the medical certificate for all of the company’s representatives who are involved in the manufacturing process.

A number of other changes, such as formatting, were made to numerous forms in the FMA application. For example, the “Outline of Buildings and Facilities” form and the “Utilization of Other Testing and Inspection Facilities” form were altered.