381 related articles for article (PubMed ID: 31382625)
1. Flexible and Expedited Regulatory Review Processes for Innovative Medicines and Regenerative Medical Products in the US, the EU, and Japan.
Nagai S
Int J Mol Sci; 2019 Aug; 20(15):. PubMed ID: 31382625
[TBL] [Abstract][Full Text] [Related]
2. The Current Status of Sakigake Designation in Japan, PRIME in the European Union, and Breakthrough Therapy Designation in the United States.
Kondo H; Hata T; Ito K; Koike H; Kono N
Ther Innov Regul Sci; 2017 Jan; 51(1):51-54. PubMed ID: 30235998
[TBL] [Abstract][Full Text] [Related]
3. Considerations and Regulatory Challenges for Innovative Medicines in Expedited Approval Programs: Breakthrough Therapy and Sakigake Designation.
Kajiwara E; Shikano M
Ther Innov Regul Sci; 2020 Jul; 54(4):814-820. PubMed ID: 32557300
[TBL] [Abstract][Full Text] [Related]
4. New Japanese Regulatory Frameworks for Clinical Research and Marketing Authorization of Gene Therapy and Cellular Therapy Products.
Nagai S; Ozawa K
Curr Gene Ther; 2017; 17(1):17-28. PubMed ID: 28382858
[TBL] [Abstract][Full Text] [Related]
5. Pharmaceuticals Licensing and Reimbursement in the European Union, United States, and Japan.
Oye KA; Eichler HG; Hoos A; Mori Y; Mullin TM; Pearson M
Clin Pharmacol Ther; 2016 Dec; 100(6):626-632. PubMed ID: 27618128
[TBL] [Abstract][Full Text] [Related]
6. Comparison of regulatory pathways for the approval of advanced therapies in the European Union and the United States.
Iglesias-Lopez C; Obach M; Vallano A; Agustí A
Cytotherapy; 2021 Mar; 23(3):261-274. PubMed ID: 33483292
[TBL] [Abstract][Full Text] [Related]
7. Breakthrough Therapy, PRIME and Sakigake: A Comparison Between Neuroscience and Oncology in Obtaining Preferred Regulatory Status.
Muensterman ET; Luo Y; Parker JM
Ther Innov Regul Sci; 2020 May; 54(3):658-666. PubMed ID: 33301147
[TBL] [Abstract][Full Text] [Related]
8. Clinical development time is shorter for new anticancer drugs approved via accelerated approval in the US or via conditional approval in the EU.
Demirci E; Omes-Smit G; Zwiers A
Clin Transl Sci; 2023 Jul; 16(7):1127-1133. PubMed ID: 37013379
[TBL] [Abstract][Full Text] [Related]
9. Achievements and challenges of the Sakigake designation system in Japan.
Tanaka M; Idei M; Sakaguchi H; Kato R; Sato D; Sawanobori K; Kawarasaki S; Hata T; Yoshizaki A; Nakamura M; Ikuma M
Br J Clin Pharmacol; 2021 Oct; 87(10):4027-4035. PubMed ID: 33694268
[TBL] [Abstract][Full Text] [Related]
10. Expediting Drug Development: FDA's New Regenerative Medicine Advanced Therapy Designation.
Vaggelas A; Seimetz D
Ther Innov Regul Sci; 2019 May; 53(3):364-373. PubMed ID: 29895180
[TBL] [Abstract][Full Text] [Related]
11. Current Trends in Clinical Development of Gene and Cellular Therapeutic Products for Cancer in Japan.
Nagai S; Sugiyama D
Clin Ther; 2019 Jan; 41(1):174-184.e3. PubMed ID: 30528048
[TBL] [Abstract][Full Text] [Related]
12. Regulatory approval pathways for anticancer drugs in Japan, the EU and the US.
Nagai S; Ozawa K
Int J Hematol; 2016 Jul; 104(1):73-84. PubMed ID: 27084259
[TBL] [Abstract][Full Text] [Related]
13. Breakthrough Therapy, PRIME and Sakigake: A Comparison Between Neuroscience and Oncology in Obtaining Preferred Regulatory Status.
Muensterman ET; Luo Y; Parker JM
Ther Innov Regul Sci; 2019 Sep; ():2168479019874062. PubMed ID: 31558045
[TBL] [Abstract][Full Text] [Related]
14. To what degree are review outcomes aligned for new active substances (NASs) between the European Medicines Agency and the US Food and Drug Administration? A comparison based on publicly available information for NASs initially approved in the time period 2014 to 2016.
Kühler TC; Bujar M; McAuslane N; Liberti L
BMJ Open; 2019 Nov; 9(11):e028677. PubMed ID: 31772082
[TBL] [Abstract][Full Text] [Related]
15. Considering Global Development? Insights from Applications for FDA Breakthrough Therapy and EMA PRIME Designations.
Hanaizi Z; Kweder S; Thor S; Ribeiro S; Marcal A
Ther Innov Regul Sci; 2023 Mar; 57(2):321-328. PubMed ID: 36307671
[TBL] [Abstract][Full Text] [Related]
16. EU Regulatory Pathways for ATMPs: Standard, Accelerated and Adaptive Pathways to Marketing Authorisation.
Detela G; Lodge A
Mol Ther Methods Clin Dev; 2019 Jun; 13():205-232. PubMed ID: 30815512
[TBL] [Abstract][Full Text] [Related]
17. Priority review drugs approved by the FDA and the EMA: time for international regulatory harmonization of pharmaceuticals?
Alqahtani S; Seoane-Vazquez E; Rodriguez-Monguio R; Eguale T
Pharmacoepidemiol Drug Saf; 2015 Jul; 24(7):709-15. PubMed ID: 26013294
[TBL] [Abstract][Full Text] [Related]
18. Regenerative medicine regulatory policies: A systematic review and international comparison.
Qiu T; Hanna E; Dabbous M; Borislav B; Toumi M
Health Policy; 2020 Jul; 124(7):701-713. PubMed ID: 32499078
[TBL] [Abstract][Full Text] [Related]
19. Regulatory and clinical development to support the approval of advanced therapies medicinal products in Japan.
Carolina IL; Antònia A; Mercè O; Antonio V
Expert Opin Biol Ther; 2022 Jul; 22(7):831-842. PubMed ID: 35762253
[TBL] [Abstract][Full Text] [Related]
20. Comparison of the new Japanese legislation for expedited approval of regenerative medicine products with the existing systems in the USA and European Union.
Jokura Y; Yano K; Yamato M
J Tissue Eng Regen Med; 2018 Feb; 12(2):e1056-e1062. PubMed ID: 28211195
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]