220 related articles for article (PubMed ID: 28299610)
1. Pharmacovigilance of Regenerative Medicine Under the Amended Pharmaceutical Affairs Act in Japan.
Inokuma Y
Drug Saf; 2017 Jun; 40(6):475-482. PubMed ID: 28299610
[TBL] [Abstract][Full Text] [Related]
2. [Translational/regulatory science researches of NIHS for regenerative medicine and cellular therapy products].
Sato Y
Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku; 2014; (132):6-9. PubMed ID: 25707195
[TBL] [Abstract][Full Text] [Related]
3. 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]
4. Consideration of and expectations for the Pharmaceuticals, Medical Devices and Other Therapeutic Products Act in Japan.
Okada K; Koike K; Sawa Y
Regen Ther; 2015 Jun; 1():80-83. PubMed ID: 31245444
[TBL] [Abstract][Full Text] [Related]
5. Regulatory perspectives of Japan.
Kusakabe T
Biologicals; 2015 Sep; 43(5):422-4. PubMed ID: 26028474
[TBL] [Abstract][Full Text] [Related]
6. Regulatory Frameworks for Gene and Cell Therapies in Japan.
Maeda D; Yamaguchi T; Ishizuka T; Hirata M; Takekita K; Sato D
Adv Exp Med Biol; 2015; 871():147-62. PubMed ID: 26374217
[TBL] [Abstract][Full Text] [Related]
7. Recent policies that support clinical application of induced pluripotent stem cell-based regenerative therapies.
Azuma K; Yamanaka S
Regen Ther; 2016 Jun; 4():36-47. PubMed ID: 31245486
[TBL] [Abstract][Full Text] [Related]
8. [Current status of the regulation and development of cell therapy products in Japan].
Igarashi Y; Sato Y
Nihon Yakurigaku Zasshi; 2018; 151(6):254-259. PubMed ID: 29887575
[TBL] [Abstract][Full Text] [Related]
9. New Governmental Regulatory System for Stem Cell-Based Therapies in Japan.
Hara A; Sato D; Sahara Y
Ther Innov Regul Sci; 2014 Nov; 48(6):681-688. PubMed ID: 30227468
[TBL] [Abstract][Full Text] [Related]
10. Regenerative medicine legislation in Japan for fast provision of cell therapy products.
Fujita Y; Kawamoto A
Clin Pharmacol Ther; 2016 Jan; 99(1):26-9. PubMed ID: 26482927
[TBL] [Abstract][Full Text] [Related]
11. Regulatory Aspects of Cell and Gene Therapy Products: The Japanese Perspective.
Maruyama Y; Noda S; Okudaira S; Sakurai A; Okura N; Honda F
Adv Exp Med Biol; 2023; 1430():155-179. PubMed ID: 37526847
[TBL] [Abstract][Full Text] [Related]
12. [Development of guidance for the approval process of brand-new medical products and regenerative medicine products].
Niimi S
Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku; 2015; (133):1-7. PubMed ID: 26821464
[TBL] [Abstract][Full Text] [Related]
13. [Doctor-initiated clinical trials and the revised pharmaceutical affairs law].
Takano T; Saijo N
Gan To Kagaku Ryoho; 2003 Oct; 30(10):1391-7. PubMed ID: 14584270
[TBL] [Abstract][Full Text] [Related]
14. Insurance systems and reimbursement concerning research and development of regenerative medicine in Japan.
Okada K; Miyata T; Sawa Y
Regen Med; 2017 Mar; 12(2):179-186. PubMed ID: 28244828
[TBL] [Abstract][Full Text] [Related]
15. The role of the Pharmaceuticals and Medical Devices Agency and healthcare professionals in post-marketing safety.
Mori K; Watanabe M; Horiuchi N; Tamura A; Kutsumi H
Clin J Gastroenterol; 2014 Apr; 7(2):103-7. PubMed ID: 26183623
[TBL] [Abstract][Full Text] [Related]
16. Establishment of the National Consortium for Regenerative Medicine and National Regenerative Medicine Database in Japan.
Okada K; Sato Y; Sugiyama D; Sawa Y
Clin Ther; 2018 Jul; 40(7):1076-1083. PubMed ID: 29958729
[TBL] [Abstract][Full Text] [Related]
17. [Review process of new oncology drug application in Japan--role of MD reviewer].
Fujiwara Y
Gan To Kagaku Ryoho; 1999 Jan; 26(2 Suppl):196-203. PubMed ID: 9987519
[TBL] [Abstract][Full Text] [Related]
18. Preclinical Toxicity Studies for Regenerative Medicine in Japan.
Shigeto J; Ichiki T; Nii T; Konno K; Nakanishi Y; Sugiyama D
Clin Ther; 2018 Nov; 40(11):1813-1822. PubMed ID: 30458928
[TBL] [Abstract][Full Text] [Related]
19. New Japanese Regulatory Frameworks for Post-Marketing Management of Pharmaceutical Products.
Takamura K; Tachibana K; Kusakabe T; Nakai K; Tsutsumi Y; Kondoh M
Pharm Res; 2020 Jun; 37(7):122. PubMed ID: 32514811
[TBL] [Abstract][Full Text] [Related]
20. Reporting of Cardiovascular Medical Device Adverse Events to Pharmaceuticals and Medical Devices Agency, Japan.
Handa N; Ishii K; Matsui Y; Ando Y
EBioMedicine; 2015 Sep; 2(9):1211-6. PubMed ID: 26501120
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]