On August 18, 2023, Japan's Pharmaceuticals and Medical Devices Agency (PMDA) updated the frequently asked questions (FAQs) for compliance inspection of Good Manufacturing Practice (GMP). As revealed by the GMP Ministerial Ordinance, when manufacturing quasi-drugs designated by the Minister of Health, Labour and Welfare (MHLW), the product shall comply with GMP through manufacturing control and quality management. Besides, an application for GMP compliance inspection is necessary.