10th Annual Meeting DIA Japan 2013

“To deliver good medicines to patients” is the important task. In order to achieve this goal, it is necessary to handle review smoothly after filing an application for approval. Last year, we particularly discussed as to the importance of good communication between the PMDA and applicants. This year, we’ll take the discussion one step further, from viewpoint of “How to make efficient communication with the PMDA in appropriate timing in the review process.” Currently, key Action Dates of query, response, reporting, etc. are determined for each PMDA consultation, but there is no big problem. When the concept of this “Key Action Date” is introduced to approval review process, what will occur? What will be brought to the review process? We’ll have discussion about the feasibility and the advantages and disadvantages of the introduction and consider deeply about “good review process”, exchanging opinions between companies and the authorities.