[Updated] Japan Approves the Amendments to Good Manufacturing Practice for Quasi-drugs

On Apr. 30, 2021, Japan Ministry of Health, Labour and Welfare (MHLW) officially approved the Ministerial Ordinance on the Good Manufacturing Practice for Quasi-Drugs and Pharmaceuticals. The amendments to the Good Manufacturing Practice for quasi-drugs will take effect on August 1^st 2021.

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On Nov. 27, 2020, Japan Ministry of Health, Labour and Welfare (MHLW) released the amendment to the Ministerial Ordinance on the Good Manufacturing Practice for Quasi-Drugs and Pharmaceuticals (hereinafter referred to as updated GMP Ministerial Ordinance) for public consultation. Advice and suggestions should be submitted before Dec. 26, 2020.

This updated GMP Ministerial Ordinance consists of 3 chapters and 53 articles. Compared with the previous edition, it refines the compliance requirements for the manufacturing and quality management of the manufacturing facility of pharmaceuticals and quasi-drugs, which includes