Japan’s Ministry of Health, Labour and Welfare (MHLW) is loosening a policy regarding post-approval changes in manufacturing, allowing pharmaceutical companies to submit “annual reports” rather than “minor change notifications” for minor changes with minimal effects on product quality. The relaxation of this rule is included as part of a draft revision to the Pharmaceuticals and Medical Devices Act, which the government plans to implement in the current Diet session.
Before being fully approved by law, the MHLW published on February 13 a notice to apply this change on a trial basis. According to this system, some Chemistry, Manufacturing, and Controls (CMC) changes that were under minor change notifications will now be qualified to be disclosed in annual reports. These encompass – 1. specific changes to certain parameters in “Manufacturing Method,” 2. text rewriting in “Specifications and Test Methods” and “Ingredient and Composition or Chemical Entity,” and 3. adding labeling, storing facilities, and testing bodies outside the company.
Marketing authorization holders have the option to consult the Pharmaceuticals and Medical Devices Agency (PMDA) before utilizing this annual report route. During the trial phase, companies have the option of filing annual reports or still following the minor change notification system.
This policy amendment is projected to simplify post-approval management of manufacturing changes as well as the administrative burden of pharma firms – while enabling sustained monitoring of the quality and safety of drug products.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.