Chapter 10: Drug Development—Japan
116
premium can range from 5% to 20%.20The rate
is decided by Chuikyo, Japan’s Central Social
Insurance Medical Council, which is an MHLW
advisory body.21
Clinical Trial Application/Marketing
Authorization Application
In Japan, the same regulatory standards (quality,
safety, and efficacy) for adult products apply to
clinical trial and marketing authorization appli-
cations for pediatric products.
Conclusion
There are no region-specific pediatric regulations
or legislation in Japan. MHLW and PMDA have
established many different initiatives and sponsor
incentives to improve conditions for pediatric
drug development. Japan regulators continue to
actively collaborate with their counterparts in
other major regions to further understand how to
address pediatric clinical study feasibility concerns,
implementation of innovative clinical trial tool
use, and regulatory reform framework intricacies.
References
1. Sato D. PMDA ACTO Satellite symposium. Japanese
regulation of regenerative medicine. PMDA website.
https://www.pmda.go.jp/files/000199507.pdf. Accessed
25 August 2021.
2. Ibid.
3. Regulatory Information Task Force. Japan
Pharmaceutical Manufacturers Association.
Information of Japanese Regulatory Affairs. 2020.
JPMA website. http://www.jpma.or.jp/english/parj/
pdf/2020.pdf. Accessed 25 August 2021.
4. Ibid.
5. Ishikawa M. PMDA’s Experiences and Challenges in
Pediatric Drug Development. PMDA website. https://
www.pmda.go.jp/files/000205910.pdf. Accessed 25
August 2021.
6. Ibid.
Figure 10-2. Pediatric Drugs Working Group Stakeholder and Process Overview
Source: Hirata M. Pediatric Drug Development in Japan and International Regulatory Collaboration. 14th DIA Japan
Annual Meeting 2017.
Table 10-3. Timeline of Key Japan Pediatric
Development Incentives
Incentive Year
Notification for extension of re-examination
period for pediatric development 2000
Premium price for approved products with
additional pediatric indications 2006
116
premium can range from 5% to 20%.20The rate
is decided by Chuikyo, Japan’s Central Social
Insurance Medical Council, which is an MHLW
advisory body.21
Clinical Trial Application/Marketing
Authorization Application
In Japan, the same regulatory standards (quality,
safety, and efficacy) for adult products apply to
clinical trial and marketing authorization appli-
cations for pediatric products.
Conclusion
There are no region-specific pediatric regulations
or legislation in Japan. MHLW and PMDA have
established many different initiatives and sponsor
incentives to improve conditions for pediatric
drug development. Japan regulators continue to
actively collaborate with their counterparts in
other major regions to further understand how to
address pediatric clinical study feasibility concerns,
implementation of innovative clinical trial tool
use, and regulatory reform framework intricacies.
References
1. Sato D. PMDA ACTO Satellite symposium. Japanese
regulation of regenerative medicine. PMDA website.
https://www.pmda.go.jp/files/000199507.pdf. Accessed
25 August 2021.
2. Ibid.
3. Regulatory Information Task Force. Japan
Pharmaceutical Manufacturers Association.
Information of Japanese Regulatory Affairs. 2020.
JPMA website. http://www.jpma.or.jp/english/parj/
pdf/2020.pdf. Accessed 25 August 2021.
4. Ibid.
5. Ishikawa M. PMDA’s Experiences and Challenges in
Pediatric Drug Development. PMDA website. https://
www.pmda.go.jp/files/000205910.pdf. Accessed 25
August 2021.
6. Ibid.
Figure 10-2. Pediatric Drugs Working Group Stakeholder and Process Overview
Source: Hirata M. Pediatric Drug Development in Japan and International Regulatory Collaboration. 14th DIA Japan
Annual Meeting 2017.
Table 10-3. Timeline of Key Japan Pediatric
Development Incentives
Incentive Year
Notification for extension of re-examination
period for pediatric development 2000
Premium price for approved products with
additional pediatric indications 2006