News & Articles about Japan - GMP

15th January, 2021

Rigorous criteria for medicines to meet Japan-GMP standard

Japan-GMP stands for Japanese quality; assessment steps last 16 to 27 months to verify that the medicine production line has…
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15th January, 2021

DHG Pharma is added JAPAN GMP standard line

With two JAPAN GMP certified production lines, DHG Pharma will provide international standard medicines to Vietnamese consumers. At the same…
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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.