The 5th Japan-Vietnam Joint Symposium" will be held
The 5th Japan-Vietnam Joint Symposium" was held in Hanoi (Vietnam) on December 2, 2025. Lively discussions were held with the aim of deepening mutual understanding of pharmaceutical regulations in both countries, further strengthening cooperative relations, and improving access to innovative medicines. The symposium featured presentations and Q&A sessions from relevant authorities and industry on three main topics: trends in pharmaceutical regulations in both countries, utilization of the Reliance Review System, and promotion of appropriate use of pharmaceutical products.
Group photo of all participants at the venue
The latest trends in pharmaceutical regulations
Regulatory trends in both countries were discussed, with the first half focusing on regulations in general and the second half on GMP.
General Trends
Takayuki Okubo, Director, Office of International Pharmaceutical Regulations, Pharmaceutical Affairs Bureau, Ministry of Health, Labour and Welfare, Japan, presented the latest information on Japanese pharmaceutical regulations. The 2025 revision of the "Act on Quality, Efficacy and Safety Assurance of Pharmaceuticals, Medical Devices and Other Drugs (Pharmaceutical Affairs Law)" includes strengthening the assurance of pharmaceutical quality and safety, enhancing the stable supply system, improving the drug discovery environment, and strengthening pharmacy functions. In August 2025, the Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) were recognized by the World Health Organization (WHO) as regulatory authorities of a certain level or higher and designated as a WHO-listed authority (WLA). PMDA's activities to support regulatory capacity building mainly in Asia were also introduced.
Next, Mr. Nguyen Tuan Anh, Deputy Director of the Drug Registration Department of the Vietnam Drug Administration (DAV), Explanation of the latest regulations on the registration of drugs and drug ingredients in Vietnam, Circular No. 12 of 2025, was presented in detail. This Circular aims to consolidate and simplify the previous complicated Circulars, reduce the burden on enterprises, facilitate procedures, and harmonize them internationally. Specifically, the registration renewal procedure has been simplified and the Reliance Examination, which utilizes examination reports from reference countries including Japan, has been introduced. Citing other regulatory authorities such as the European Medicines Agency (EMA) as examples, he called on the Japanese authorities to cooperate in establishing an online system to verify the authenticity of legal documents and to provide online English versions of review reports to facilitate the Reliance Review.
Good Manufacturing Practice (GMP) Conformity Assessment
Mr. Vu Duc Canh, Deputy Director of DAV's Pharmaceutical Quality Control Division, explained the methods and required documents for GMP conformity assessment of foreign manufacturers. Reliance is also utilized in GMP evaluations when submitting GMP certifications issued by the Japanese authorities. However, since the GMP certificate issued by the Japanese authorities may not fully meet the requirements of Vietnam, it is allowed to submit a consular certified GMP inspection report or a notice of inspection results as additional documentation.
Next, Mr. Yu Miyata, Specialist in Generic Drugs Inspection, MHLW, Pharmaceutical Surveillance, Guidance and Drug Control Division, explained the GMP inspection system and GMP certificates in Japan. There are two types of periodic inspections after approval: "conformity inspections" and "category conformity inspections," which are conducted for each manufacturing process category. On the other hand, only the former type of periodic inspections is set for export-use drugs. Recently, a plan has been presented to shorten the frequency of post-marketing GMP inspections for domestically approved drugs from the current five years to three years, and it is also under consideration to shorten the frequency of inspections for export drugs to three years as well as to apply the category conformity survey to export drugs.
Effective Utilization of Reliance Assessment
This was the most important theme of the symposium, and both the regulatory and industry sessions featured presentations on the Reliance Review initiative.
Initiatives by Regulatory Authorities
Mr. Nguyen Tuan Anh, Deputy Director of the DAV's Drug Registration Division, explained the new Reliance Review process established by the aforementioned Circular No. 12. In addition to the documents required for the regular review, the applicant for the Reliance Review must submit the review report of the reference regulatory authority, the application documents approved in the reference country, and a comparison chart that clearly indicates the differences with the application documents submitted to Vietnam. The review period will be reduced from 12 months to 9 months for the normal review, and a more predictable and efficient review process is expected.
Next, Mr. Shinichi Noda, Planning and Management Division, International Planning Department, PMDA, explained PMDA's support system for the use of Japanese review reports in the Reliance review in Vietnam. The PMDA's International Division has country-specific representatives for the Reliance Scheme, who communicate directly with DAVs when they have questions about the PMDA's review, and help resolve doubts at an early stage and expedite approvals. Japanese review reports are prepared in Japanese, and for some products, English translations are published with confidential information masked, but companies prepare and submit an unmasked English version of the review report for Reliance review applications.
Industry Initiatives
JPMA International Affairs Committee Asia Committee member Hiromi Murabayashi, representing the Japanese industry, and Pharma Group (PG) Executive Director Thuy Nguyen, representing the R & D Committee of Vietnam, shared best practices from other countries' Reliance Review experiences. JPMA recommends the attachment of a cover letter to the review report in collaboration with the PMDA as a best practice when referring for approval in Japan. PG proposed a four-way working group meeting between the two authorities, JPMA, and PG as a way for the industry to support the smooth execution of the Reliance Review, which was endorsed by the DAV.
Hiromi Murabayashi, a member of the JPMA's International Affairs Committee's Asia Subcommittee, took the podium.
The keynote speech by Yasunori Yoshida, JPMA's Executive Director, also highlighted the efforts of the Japanese authorities and the pharmaceutical industry as reference countries for Reliance Assessment, and indicated that the public and private sectors will continue to cooperate to achieve safe and rapid access to innovative drugs.
JPMA Executive Director Yasunori Yoshida on stage
Promotion of Proper Use of Drugs
In order to ensure the prompt delivery of innovative medicines to patients, it is also essential to improve the environment for the proper use of medicines. Ms. Jyunmi Maruyama, leader of the Access Group of the Global Health Subcommittee of the JPMA International Affairs Committee, introduced the progress of JPMA's project in cooperation with Bac Mai Hospital (BMH) in Hanoi to promote the proper use of medicines in Vietnam. JPMA is focusing on capacity building for clinical pharmacists to meet local needs, developing and improving work manuals and patient medication guidance materials, and providing training on communication with patients and their families, risk management including adverse drug reaction reporting, and other topics to the National Center for Global Medical Research (NCGM) and the National National Cancer Center Hospital (NCCH) in collaboration with the National Center for Cancer Research and Development (NCGM) and the National Cancer Center Hospital (NCCH), and has been developing this program since 2018. In a panel discussion that also featured Bui Thi Ngoc Thuc, pharmacist at Bac Mai Hospital (BMH) in Hanoi, Vietnam, who is participating in the training, shared valuable experiences on the tremendous benefits the project brings to healthcare delivery and patients at BMH, and practical challenges and innovations in materials development. The panelists also shared their valuable experiences on the practical challenges and innovations in material development.
Panel discussion
Concluding Remarks
In his closing remarks, Mr. Chu Dang Tung, Director of DAV's International Regulatory Integration Division, expressed his gratitude for the cooperation from Japan thus far and expressed his confidence that the project has achieved its goal of introducing the Reliance Review, which utilizes the review reports of the reference countries.
We will continue to work with the regulatory authorities and industry associations in both countries, believing that building on these achievements and further developing them will be the first step toward the prompt and safe delivery of medicines to patients.
(Masayo Higashiyama, Leader, Vietnam Group, International Affairs Committee, Asia)