More than 30 years pursuing Japan-GMP, Mr. Tomoyuki Kawata has relieved many consumer concerns about Japan's highest drug quality certification.

Japan-GMP standard medicines are attracting great attention of consumers, especially in Vietnam, there are only 3 pharmaceutical enterprises meeting this standard.

With more than 30 years of experience pursuing Japan-GMP, Mr. Tomoyuki Kawata – General Manager of international technical operations - Taisho Pharmaceutical Group, Deputy General Director in charge of Production, Supply Chain and Technology Transfer - DHG Pharma will clarify this certification further.

Mr. Kawata graduated from Tokyo University of Biopharmaceuticals. He has worked at Taisho Pharmaceuticals (Japan) - Top 5 largest pharmaceutical corporations in Japan for 27 years, in charge of production quality control and extremely familiar with Japan-GMP. He moved to Vietnam and has been working at DHG Pharma since 2017.

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.

How is the process of issuing Japan-GMP?

Japan-GMP accreditation process goes through 2 phases. In phase 1, enterprises must be licensed to operate in the pharmaceutical sector in Japan. Phase 2, assessment and recognition of Japan-GMP standards for registered products.

Mr. Kawata said that in phase 2, PMDA will evaluate the registered products in terms of quality, efficiency, safety. In the process, they also conducted an assessment of whether the plant is in accordance with Japan-GMP standard.

From the application period to the receipt of Japan-GMP certification, it usually takes one year. If the application is not thorough enough, it can last up to two years.

Mr. Kawata emphasized that achieving this certification is extremely difficult. PMDA offers a number of extremely strict technical barriers and unique Japanese characteristics, ensuring that the drug must be of the highest quality when it reaches the patient. Specifically, the production process on Japan-GMP line is based on a comprehensive management system and quality assurance from raw material stage to production, testing, input - output warehouse, and distribution to the market.

Once certified, Japan-GMP will be valid for 5 years. When the validity expires, the enterprise must undergo re-evaluation rounds from the beginning in order to be renewed. During that time, it is necessary to maintain a uniform management system that meets Japan-GMP, if there are any changes, it must be reported in a timely manner.

How does Japan-GMP benefit society?

Representing the highest quality in Japan, Japan-GMP has become the highest standard in many countries around the world. The pursuit of Japan-GMP by Vietnamese enterprises is a good sign for society, bringing benefits to consumers, the health sector and the country.

Mr. Kawata said that there are now nearly 100 DHG Pharma’s products produced on 2 tablet and film-coated tablet lines reaching Japan-GMP. Consumers now have complete peace of mind and easy access to antibiotics, analgesic - antipyretic, nervous, hepatobiliary, digestive, cardiovascular, diabetes, etc. with international standards at very affordable prices.

Japan-GMP was also selected as a preferred standard for medicines entering official treatment channel in hospitals. Lines of antibiotics (Clabact 250 and 500, Zaromax 250 and 500), nervous (Neni 800), digestive, hepatobiliary (Raxium), cardiovascular (Vastec), respiratory (Telfor 60, 120, 180), analgesic - antipyretic (Hapacol 325, 650 ...) etc. with superior quality and competitive price will reach the patient.

Owning Japan-GMP, DHG Pharma also has the advantage of exporting drugs to difficult markets, such as Japan. With the position of "leading bird" in the field of medicines and breakthrough with Japan-GMP line, the enterprise expects to contribute to the identity of Vietnamese medicines on the global pharmaceutical industry map.

Mr. Tomoyuki Kawata – General Manager of international technical operations -

Taisho Pharmaceutical Group, Deputy General Director in charge of Production, Supply Chain and Technology Transfer - DHG Pharma

Inside DHG's Japan GMP standard production line