These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.
230 related articles for article (PubMed ID: 31543814)
1. Regulatory Framework for Advanced Therapy Medicinal Products in Europe and United States. Iglesias-López C; Agustí A; Obach M; Vallano A Front Pharmacol; 2019; 10():921. PubMed ID: 31543814 [TBL] [Abstract][Full Text] [Related]
2. 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]
3. Advanced Therapy Medicinal Products for Rare Diseases: State of Play of Incentives Supporting Development in Europe. Farkas AM; Mariz S; Stoyanova-Beninska V; Celis P; Vamvakas S; Larsson K; Sepodes B Front Med (Lausanne); 2017; 4():53. PubMed ID: 28560211 [TBL] [Abstract][Full Text] [Related]
4. Advanced Therapy medicinal products for autologous chondrocytes and comparison of regulatory systems in target countries. Kim J; Park J; Song SY; Kim E Regen Ther; 2022 Jun; 20():126-137. PubMed ID: 35582708 [TBL] [Abstract][Full Text] [Related]
5. Advanced Therapy Medicinal Products for the Eye: Definitions and Regulatory Framework. López-Paniagua M; de la Mata A; Galindo S; Blázquez F; Calonge M; Nieto-Miguel T Pharmaceutics; 2021 Mar; 13(3):. PubMed ID: 33800934 [TBL] [Abstract][Full Text] [Related]
6. Call for More Effective Regulation of Clinical Trials with Advanced Therapy Medicinal Products Consisting of or Containing Genetically Modified Organisms in the European Union. Beattie S; Hum Gene Ther; 2021 Oct; 32(19-20):997-1003. PubMed ID: 33843251 [TBL] [Abstract][Full Text] [Related]
7. Post-marketing authorisation safety and efficacy surveillance of advanced therapy medicinal products in Brazil, the European Union, the United States and Japan. Gomes KLG; da Silva RE; da Silva JB; Bosio CGP; Novaes MRCG Cytotherapy; 2023 Oct; 25(10):1113-1123. PubMed ID: 37436339 [TBL] [Abstract][Full Text] [Related]
8. Marketing Regulatory Oversight of Advanced Therapy Medicinal Products (ATMPs) in Europe: The EMA/CAT Perspective. Salmikangas P; Schuessler-Lenz M; Ruiz S; Celis P; Reischl I; Menezes-Ferreira M; Flory E; Renner M; Ferry N Adv Exp Med Biol; 2015; 871():103-30. PubMed ID: 26374215 [TBL] [Abstract][Full Text] [Related]
9. Hurdles of environmental risk assessment procedures for advanced therapy medicinal products: comparison between the European Union and the United States. Iglesias-Lopez C; Obach M; Vallano A; Agustí A; Montané J Crit Rev Toxicol; 2019 Aug; 49(7):580-596. PubMed ID: 31846383 [TBL] [Abstract][Full Text] [Related]
10. Regulatory Frameworks for Advanced Therapy Medicinal Products in Thailand. Boonprasirt P; Nimvorapun S; Sawangjang C; Poonpolsub S; Yoongthong W; Dunkum P Adv Exp Med Biol; 2023; 1430():221-233. PubMed ID: 37526851 [TBL] [Abstract][Full Text] [Related]
11. The Current State of Advanced Therapy Medicinal Products in the Czech Republic. Kočí Z; Boráň T; Krůpa P; Kubinová Š Hum Gene Ther Clin Dev; 2018 Sep; 29(3):132-147. PubMed ID: 29869533 [TBL] [Abstract][Full Text] [Related]
12. Regulatory approval for autologous human cells and tissue products in the United States, the European Union, and Japan. Yano K; Watanabe N; Tsuyuki K; Ikawa T; Kasanuki H; Yamato M Regen Ther; 2015 Jun; 1():45-56. PubMed ID: 31589662 [TBL] [Abstract][Full Text] [Related]
13. Challenges with advanced therapy medicinal products and how to meet them. ; ; Schneider CK; Salmikangas P; Jilma B; Flamion B; Todorova LR; Paphitou A; Haunerova I; Maimets T; Trouvin JH; Flory E; Tsiftsoglou A; Sarkadi B; Gudmundsson K; O'Donovan M; Migliaccio G; Ancāns J; Maciulaitis R; Robert JL; Samuel A; Ovelgönne JH; Hystad M; Fal AM; Lima BS; Moraru AS; Turcáni P; Zorec R; Ruiz S; Akerblom L; Narayanan G; Kent A; Bignami F; Dickson JG; Niederwieser D; Figuerola-Santos MA; Reischl IG; Beuneu C; Georgiev R; Vassiliou M; Pychova A; Clausen M; Methuen T; Lucas S; Schüssler-Lenz M; Kokkas V; Buzás Z; MacAleenan N; Galli MC; Linē A; Gulbinovic J; Berchem G; Fraczek M; Menezes-Ferreira M; Vilceanu N; Hrubisko M; Marinko P; Timón M; Cheng W; Crosbie GA; Meade N; di Paola ML; VandenDriessche T; Ljungman P; D'Apote L; Oliver-Diaz O; Büttel I; Celis P Nat Rev Drug Discov; 2010 Mar; 9(3):195-201. PubMed ID: 20190786 [TBL] [Abstract][Full Text] [Related]
14. Regulatory Aspects for Approval of Advanced Therapy Medicinal Products in the EU. Fürst-Ladani S; Bührer A; Fürst W; Schober-Ladani N Handb Exp Pharmacol; 2024; 284():367-387. PubMed ID: 37017789 [TBL] [Abstract][Full Text] [Related]
15. Advanced therapy medicinal products: current and future perspectives. Hanna E; Rémuzat C; Auquier P; Toumi M J Mark Access Health Policy; 2016; 4():. PubMed ID: 27123193 [TBL] [Abstract][Full Text] [Related]
16. Clinical Development and Commercialization of Advanced Therapy Medicinal Products in the European Union: How Are the Product Pipeline and Regulatory Framework Evolving? Boráň T; Menezes-Ferreira M; Reischl I; Celis P; Ferry N; Gänsbacher B; Krafft H; Lipucci di Paola M; Sladowski D; Salmikangas P Hum Gene Ther Clin Dev; 2017 Sep; 28(3):126-135. PubMed ID: 28510497 [TBL] [Abstract][Full Text] [Related]
17. Business oriented EU human cell and tissue product legislation will adversely impact Member States' health care systems. Pirnay JP; Vanderkelen A; De Vos D; Draye JP; Rose T; Ceulemans C; Ectors N; Huys I; Jennes S; Verbeken G Cell Tissue Bank; 2013 Dec; 14(4):525-60. PubMed ID: 24052113 [TBL] [Abstract][Full Text] [Related]
18. A pipeline analysis of advanced therapy medicinal products. Wilkins GC; Lanyi K; Inskip A; Ogunbayo OJ; Brhlikova P; Craig D Drug Discov Today; 2023 May; 28(5):103549. PubMed ID: 36963609 [TBL] [Abstract][Full Text] [Related]
19. Regulatory structures for gene therapy medicinal products in the European Union. Klug B; Celis P; Carr M; Reinhardt J Methods Enzymol; 2012; 507():337-54. PubMed ID: 22365782 [TBL] [Abstract][Full Text] [Related]
20. Cell therapy medicinal product regulatory framework in Europe and its application for MSC-based therapy development. Ancans J Front Immunol; 2012; 3():253. PubMed ID: 22912639 [TBL] [Abstract][Full Text] [Related] [Next] [New Search]