Trial of Introduction of Change Procedures for Moderate Changes

The document outlines a new trial designed to streamline the approval process for moderate changes in pharmaceutical manufacturing methods. Here are the key elements of the trial:

1. Purpose: The trial aims to expedite the review process for moderate-risk changes related to the manufacturing methods, specifications, and testing methods of ethical drugs. This includes adjustments to storage methods and validity periods.
2. Review Timeline: The review period is set at 40 business days from the submission of the application to the issuance of approval, facilitating quicker adjustments in manufacturing practices.
3. Scope of Changes: The trial focuses on changes that do not necessitate Good Manufacturing Practice (GMP) conformity studies or revisions to biologics standards. This allows for faster processing of modifications that are considered low to moderate risk.
4. Application Requirements:
   • Applicants must clearly identify the target change in their approval letter or consult with the Pharmaceuticals and Medical Devices Agency (PMDA) prior to submission.
   • Applications should include the priority examination code “”19125″” and, if relevant, the clinical trial consultation number.
5. Confirmation Process: The PMDA will confirm the acceptance of applications within 10 business days and will communicate the results to the applicant promptly.
6. Application Limitations: To manage the trial effectively, the PMDA will limit the number of applications to approximately 15 per month, processed on a first-come, first-served basis.

This initiative is designed to enhance the efficiency of the approval process for moderate changes in pharmaceutical manufacturing, thereby supporting quicker implementation of improvements in drug production.

Source: https://www.mhlw.go.jp/hourei/doc/tsuchi/T240927I0010.pdf

Region:  Japan