Global Pediatric Development of Drugs, Biologics, and Medical Devices
117
7. International Council for Harmonisation of Technical
Requirements for Pharmaceuticals for Human Use.
Addendum to ICH E11: Clinical Investigation of
Medicinal Products in the Pediatric Population E11 (R1).
ICH website. https://database.ich.oarg/sites/default/
files/E11_R1_Addendum.pdf. Accessed 25 August
2021.
8. Medicinal product. EMA website. https://www.ema.
europa.eu/en/glossary/medicinal-product. Accessed 25
August 2021.
9. Op cit 7.
10. Hirata M. Pediatric Drug Development in Japan and
International Regulatory Collaboration. 14th DIA
Japan Annual Meeting 2017. PMDA website. https://
www.pmda.go.jp/files/000224497.pdf#:~:text=Re-ex-
amination%20Period%20%28market%20exclusivity%20
and%20data%20protection%29%20of,per%20the%20
necessary%20time%20to%20conduct%20appropri-
ate%20study. Accessed 25 August 2021.
11. Ibid.
12. Op cit 5.
13. Ibid.
14. Baum V, Bax R, Heon D, et al. Pediatric Drug
Regulation: International Perspectives. Pediatric
Anesthesia. 1039 29:572-582.
15. Ibid.
16. Op cit 5.
17. Op cit 10.
18. Op cit 14.
19. Op cit 14.
20. Ibid.
21. Pacific Bridge Medical. Japan to increase drug price
rates for innovative products. Pacific Bridge Medical
website. https://www.pacificbridgemedical.com/
news-brief/japan-to-increase-drug-price-rates-for-in-
novative-products/. Accessed 25 August 2021.
117
7. International Council for Harmonisation of Technical
Requirements for Pharmaceuticals for Human Use.
Addendum to ICH E11: Clinical Investigation of
Medicinal Products in the Pediatric Population E11 (R1).
ICH website. https://database.ich.oarg/sites/default/
files/E11_R1_Addendum.pdf. Accessed 25 August
2021.
8. Medicinal product. EMA website. https://www.ema.
europa.eu/en/glossary/medicinal-product. Accessed 25
August 2021.
9. Op cit 7.
10. Hirata M. Pediatric Drug Development in Japan and
International Regulatory Collaboration. 14th DIA
Japan Annual Meeting 2017. PMDA website. https://
www.pmda.go.jp/files/000224497.pdf#:~:text=Re-ex-
amination%20Period%20%28market%20exclusivity%20
and%20data%20protection%29%20of,per%20the%20
necessary%20time%20to%20conduct%20appropri-
ate%20study. Accessed 25 August 2021.
11. Ibid.
12. Op cit 5.
13. Ibid.
14. Baum V, Bax R, Heon D, et al. Pediatric Drug
Regulation: International Perspectives. Pediatric
Anesthesia. 1039 29:572-582.
15. Ibid.
16. Op cit 5.
17. Op cit 10.
18. Op cit 14.
19. Op cit 14.
20. Ibid.
21. Pacific Bridge Medical. Japan to increase drug price
rates for innovative products. Pacific Bridge Medical
website. https://www.pacificbridgemedical.com/
news-brief/japan-to-increase-drug-price-rates-for-in-
novative-products/. Accessed 25 August 2021.