MHLW Establishes New System for Consultation in Japan

In the past, visits to Japan’s Ministry of Health, Labor and Welfare (MHLW) for advice were free and non-binding. At these sessions, the MHLW officials usually would not make any comments, or if any comments were made, they normally did not carry weight in future discussions. Now, the MHLW will be offering a new consultation service for medical companies in Japan. While the final details are still evolving, the service includes three types of consultation.

First, a Preliminary Consultation offers the applicant initial feedback on their situation. The thirty minute service is free of charge and requires only the applicant be present. Generally, two days per month are available for making an appointment and the consultation will take place about one week later. The submittal of materials, including an appointment application form and list of questions, is required at the time of scheduling.

Second, the applicant may schedule a Regular Consultation, providing assistance with the application without prior review of the relevant documents. Appointments are held on Thursdays and Fridays and started on May 20. The scheduling must be done on Thursday, a week prior to the appointment. A list of questions and the relevant materials must be submitted at the time of scheduling. This consultation service lasts thirty minutes and costs 36,200 yen (about $350 USD).

Third, a consultation regarding the application, including prior review of the relevant documents, is provided during a Detailed Consultation. This service will last a maximum of two hours and costs 1,697,200 yen (about $16,000 USD). Along with the applicant, representatives from the manufacturer, as well as experts, are permitted to be present. Following the consultation, the MHLW will prepare the minutes and then issue them after receiving approval from the applicant. A list of questions is required and must be submitted on the Monday three weeks prior to the consultation date. However, the dates for scheduling and holding a Detailed Consultation are being determined now and are not yet available. At the meeting, the MHLW will give a recommendation on what they expect to happen during the regulatory process. While this recommendation will help provide incite into what the MHLW is likely to do, it is still non-binding.