On 1 July 2024, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) announced the establishment of its first overseas office, the PMDA Asia office. This office is now open in Bangkok, Thailand, and is headed by Dr Kitahara Jun.
This office has been set up to actively contribute to the improvement of public health and pharmaceutical safety in Asian countries including Japan. It aims to improve access to innovative drugs and medical devices in the regions. It will also play a role in promotion of pharmaceutical regulatory harmonization in Asian countries, and supporting the improvement of the pharmaceutical regulatory environment, thereby advancing clinical development across Asia.
The initiative advances the ‘grand design for Asian pharmaceutical and medical device regulatory harmonization’ that Japan introduced in 2019, as well as the international contributions and proposals outlined by the PMDA in its fifth mid-term plan. Japan has a well-established and active biosimilars market with developed regulatory systems in place [1-3]. With this experience, the PMDA Asia office can help promote the regulation and uptake of these products in the wider region, improving access to medicines and treatment options.
Overall, the PMDA stated that ‘the Asia office will provide the services including the development of regulatory cooperation platforms with Asian regulatory authorities, direct information exchange on pharmaceutical regulation and various consultations, as well as other related services to companies or organizations expanding in the Asian regions, and local companies or organizations.’
In August 2024, the PMDA will hold an International Symposium for Asia Regulatory Coordination in collaboration with the Ministry of Health, Labour and Welfare to celebrate the establishment of this Asia Office.
Furthermore, the PMDA plans to open a US office, likely in Washington, by March 2025, to offer free consultations to aid US startups develop drugs in Japan.
Additionally, in response to the delay between global approvals and those in Japan, the government is working to accelerate the entry of companies into the market. To address this issue, they have revised their strategies for local clinical trials and drug pricing.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Japanese guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Aug 6]. Available from: www.gabionline.net/guidelines/Japanese-guidelines-for-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. Japanese opportunity for biosimilars[www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Aug 6]. Available from: www.gabionline.net/reports/Japanese-opportunity-for-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. Three darbepoetin alfa biosimilars approved in Japan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Aug 6]. Available from: www.gabionline.net/biosimilars/news/Three-darbepoetin-alfa-biosimilars-approved-in-Japan
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