Japanese companies may present applications in person:
This article was originally published in Clinica
Executive Summary
Japanese companies filing for product approvals are to be permitted to present their products and associated data to the licensing authorities in person, under a new move designed to curtail the sometimes lengthy approval process. Questions and answers on a product may flow to and fro between authority and applicant, the licensing authorities sometimes needing explicit explanations on new technologies. The person-to-person approach may offer a short cut, with each company able to present for 30 minutes and then be expected to respond to questions for a similar length of time. Prefectural governments were informed of the new application filing method in March.