The Japanese Ministry of Health, Labor and Welfare recently announced in October 2003, their plan for a notification system for minor changes in approved medical products. The guidelines for the notification system will be included as part of the revised Pharmaceutical Affairs Law (PAL) and is expected to be put in place by 2005. Under the notification system, manufacturers and sellers of pharmaceutical and medical products must notify the MHLW of minor changes from their approved product’s details.
Notification must be made to the MHLW should the medical product’s details change from those registered under the Master File. Any changes in the product’s name, dosage, manufacturing method, quality, effect, active ingredients, excipients, and materials used, need to be reported under the proposed system. The guidelines will also include what types of changes constitute minor changes. The ministry will provide a means for manufacturers and sellers to inquire if a medical product’s changes can be dealt with through the notification system. Medical products with major changes must go through a formal application process (partial change amendments) which must be filed with the MHLW for examination and approval.