News & Articles about Japan - GMP

16th August, 2022

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What does Japan - GMP standard mean?

What is Japan-GMP standard?

Japan-GMP is the Japanese Good Manufacturing Practice standard. In Japan, Japan-GMP has been established since 1974 and came into force in 1975, before EU-GMP (1989), and is constantly being updated to increase difficulty.

Japan-GMP is directly certified by Japan Medicines and Medical Devices Agency (PMDA). The agency is under the Ministry of Health, Labour and Welfare of Japan (MHLW).

In theory, Japan-GMP is equivalent to PIC/S-GMP of PIC/S, EU-GMP of Europe, CGMP-USA of the United States, etc. However, according to Pacific Bridge Medical (PBM), in fact, Japan-GMP often requires stricter quality control and assurance than western countries.

ANNOUNCEMENT CEREMONY OF FILM-COATED TABLET AND TABLET PRODUCTION LINE WITH JAPAN GMP STANDARD

In December, 2020 in Can Tho, an announcement ceremony of JAPAN GMP certification for DHG Pharma’s medicine production line was held respectfully. Attending the ceremony were leaders of Can Tho City Department of Health, leaders of Mekong Delta hospitals, close customers, DHG Pharma’s leaders and employees.