News & Articles about Japan - GMP

25th March, 2021

How have pharmaceutical companies been taking advantages from FTAs?

In the context of late 2020 and early 2021, free trade agreements open up more challenges than opportunities for domestic…
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25th March, 2021

5 years – raising an international level of DHG Pharma

The Taisho and DHG story is a “sweet fruit” of the post-M&A pharmaceutical industry, after 5 years of starting to…
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25th March, 2021

2 years – 2 Japan-GMP lines, affirming Taisho’s accompanying commitment to Vietnamese people at DHG Pharma

After 5 years of cooperation, the result of 2 tablet and film-coated tablet production lines achieving Japan-GMP certification in 2019…
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28th January, 2021

Nearly 100 DHG Pharma’s products are of Japan-GMP quality

After 3 years of pursuing Japan-GMP, DHG Pharma has currently owned a list of nearly 100 products meeting Japanese quality…
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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.