PMDA established PMDA Asia Office as its first oversea base
PMDA Asia Office Introduction Video (English)
Objectives of establishment of PMDA Asia Office
PMDA Asia Office has been established in Bangkok, the Kingdom of Thailand on 1st, July 2024 as the PMDA’s first oversea base.
PMDA has been providing regulatory trainings for regulatory officials in the Asian region through Asia pharmaceuticals and medical devices training center (PMDA-ATC) and contributed to improve access to the medical products and to strengthen regulatory capacities and regulatory harmonization in Asia. PMDA Asia Office will also contribute further for encouraging harmonisation of pharmaceuticals and medical devices regulation and to assist streamlining regulation for facilitating clinical development in the Asian region towards improved access to innovative pharmaceuticals and medical devices etc. in the Asia region, and hence actively involved in improved health and safety in the Asian countries including Japan.
Ref. Establishment of PMDA Asia Office - as First Overseas Base - (News Release) [266.84KB]
Services of PMDA Asia Office
PMDA Asia Office aims to improve public health in the Asian region by providing the services including development of regulatory cooperation platforms with Asian regulatory authorities, providing direct information exchange on pharmaceutical regulation and various consultations, other related services with companies or organizations expanding in the Asian regions, and local companies or organizations.
Message from the Head of the PMDA Asia Office
My name is Shinichi NODA, and I assumed the position of Head of the Asia Office in April 2026.
Throughout my career, I have been involved in the review of cell and gene therapy products, pharmaceutical safety activities, as well as international outreach aimed at explaining Japan’s pharmaceutical regulatory system to overseas partners.
As global environment continues to evolve, the importance of international regulatory harmonization and close collaboration among Asian regulatory authorities to strengthen regulatory capacity is becoming ever more significant. I look forward to maintaining open dialogue with regulators and stakeholders throughout Asia and to working together to enhance regulatory environments that reflect the needs of each region.
Head
Asia Office
Pharmaceuticals and Medical Devices Agency (PMDA)
Shinichi NODA, Ph.D.
April 2026
Access
388 Exchange Tower, Unit 2202-2 FL 22, Sukhumvit Road, Khlong Toey Subdistrict, Khlong Toey District, Bangkok 10110, Thailand
Collaborative Initiatives with ASEAN Regulatory Authorities (Asia Office)
The PMDA Asia Office will work together with ASEAN regulatory authorities to share practical challenges faced by each authority and jointly explore possible solutions.
GMP
As the pharmaceutical supply chain becomes increasingly globalized, regulatory authorities are expected to appropriately monitor and guide manufacturing sites through GMP inspections to ensure the quality assurance and stable supply of marketed pharmaceuticals under an international oversight framework.
Amid the limited human resources across authorities, it is important to establish a framework for continuous capability enhancement based on collaboration with overseas regulators to carry out inspections that maintain international standards.
In this context, the PMDA Asia Office, in collaboration with ASEAN regulatory authorities, is implementing a three-year program aimed at accumulating knowledge of issues identified in GMP inspections and enhancing practical inspection capabilities. The program includes an annual in-person workshop, as well as online follow-up activities.
- 1st Workshop (March 2026), Report
Clinical Trial and GCP Workshop
As the global environment for medical product development evolves and development sites become increasingly diverse, ASEAN is expected to grow in importance not only as a pharmaceutical market but also as a strategic location for clinical trials, supported by its large population and economic growth.
At the same time, for ASEAN countries to promote the development of medical products and ensure patient access within their countries, it is essential to establish an environment in which clinical trials can be conducted sustainably.
To support these efforts, the PMDA Asia Office, in collaboration with ASEAN regulatory authorities, is implementing a three-year program to strengthen regulatory approaches to clinical trials and enhance GCP inspection capacity. The program provides opportunities to share and discuss each authority’s experiences, practical challenges, and ongoing efforts. It includes an annual in-person workshop as well as online follow-up activities.
- 1st Workshop (May 2026), Report
International Symposium for Asia Regulatory Coordination
To commemorate the establishment of Asia Office, “International Symposium for Asia Regulatory Coordination” was held. A total of about 120 participants joined the symposium, including H.E. Prof. TAKEMI Keizo, the Minister of Health, Labour and Welfare (at that time), Dr. FUJIWARA Yasuhiro, the Chief executive of PMDA, top level representatives from Asian regulatory agencies, and representatives of industry in Asian region.
For the details of the symposium, please refer to page of International Symposium for Asia Regulatory Coordination.