CORRECTION published: 25 May 2020 doi: 10.3389/fphar.2020.00766 Corrigendum: Regulatory Framework for Advanced Therapy Medicinal Products in Europe and United States Carolina Iglesias-Lopez 1, Antonia Agustı́ 1,2, Mercè Obach 3* and Antonio Vallano 3,4 1Department of Pharmacology, Therapeutics and Toxicology, Universitat Autònoma de Barcelona, Barcelona, Spain, 2Clinical Pharmacology Service, Vall d'Hebron University Hospital, Barcelona, Spain, 3 Medicines Department, Catalan Healthcare Service, Barcelona, Spain, 4 Pathology and Experimental Therapeutics Department, University of Barcelona, Barcelona, Spain Keywords: genetic therapy, tissue engineering, cell- and tissue-based therapy, biological products, biological therapy, legislation and jurisprudence, United States Food and Drug Administration, Europe A Corrigendum on Edited by: Regulatory Framework for Advanced Therapy Medicinal Products in Europe and United States Ileana Mardare, by Iglesias-Lopez C, Agustı́ A, Obach M and Vallano A (2019). Front. Pharmacol. 10:921. doi: Carol Davila University of Medicine and 10.3389/fphar.2019.00921 Pharmacy, Romania Reviewed by: In the original article, there was an error. In the specified paragraph, the word “latter” and “former” Adina Turcu-Stiolica, should be interchanged. A correction has been made to the Regulatory Framework for the University of Medicine and Pharmacy of Craiova, Romania Classification of Advanced Therapies section, paragraph 8: *Correspondence: “Finally, it is worth noting that the main EU and US Agencies have launched expedited Mercè Obach development programs in order to enable new medicines reach the market as early as mobach@catsalut.cat possible. The medicines that are eligible to these programs are those that can justify a potential major public health interest, i.e., they target conditions where there is an unmet Specialty section: This article was submitted to medical need or have the potential to bring a major therapeutic advantage to patients. Pharmaceutical Medicine Since ATMPs usually offer new treatments for currently incurable conditions or improve and Outcomes Research, existing treatments, most ATMP are eligible to these types of accelerated programs. The a section of the journal FDA has developed the Breakthrough Therapy and Fast Track designation programs Frontiers in Pharmacology (U.S. Food and Drug Administration, 2018d), while the EU launched the adaptive Received: 20 April 2020 licensing and afterwards the PRIority Medicines (PRIME) designation scheme. The Accepted: 11 May 2020 difference between the Breakthrough Therapy and Fast track designations falls on the Published: 25 May 2020 qualifying criteria for the designation. In the latter, clinical or nonclinical data should Citation: demonstrate potential to address an unmet medical need, whereas in the former, Iglesias-Lopez C, Agustı´ A, Obach M preliminary clinical evidence indicates that it may demonstrate substantial and Vallano A (2020) Corrigendum: improvement over available therapies on a clinically significant endpoint(s). The Regulatory Framework for EU PRIME and the US Breakthrough Therapy designations share the same objective Advanced Therapy Medicinal Products in Europe and United States. (timely patient access to innovative medicines) but have a different legal basis; hence, Front. Pharmacol. 11:766. comparison and harmonization are difficult. However, since late 2016, FDA and EMA doi: 10.3389/fphar.2020.00766 have worked together to track submitted requests for PRIME and Breakthrough Frontiers in Pharmacology | www.frontiersin.org 1 May 2020 | Volume 11 | Article 766 Iglesias-Lopez et al. Advanced Therapies Regulatory Framework Therapy designations and compare final review designations awarded in the US, EU, and Japan, is outcom es , including specific reas ons for a foreseen to be launched (Regulatory Affairs designation request denial (European Medicines Professional Society, 2019).” Agency, 2018b). Throughout 2019, a database utilizing publicly available and company provided The authors apologize for this error and state that this does information to create a public list of RMAT not change the scientific conclusions of the article in any way. recipients, as well as other expedited approval The original article has been updated. REFERENCES U.S. Food and Drug Administration. (2018b). 21st Century Cures Act. Available online at: https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/ Regulatory Affairs Professional Society. (2019). Regulatory Intelligence: update on SignificantAmendmentstotheFDCAct/21stCenturyCuresAct/default.htm. regenerative medicine advanced therapies designations. Available online at: https://www.raps.org/news-and-articles/news-articles/2019/5/regulatory- intelligence-update-on-regenerative-me. doi: 10.1016/B978-0-12-410396- Copyright © 2020 Iglesias-Lopez, Agustı ́, Obach and Vallano. This is an open-access 2.00005-0 article distributed under the terms of the Creative Commons Attribution License (CC U.S. Food and Drug Administration. (2018d). Fast track, breakthrough therapy, BY). The use, distribution or reproduction in other forums is permitted, provided the accelerated approval, priority review. Available online at: https://www.fda.gov/ original author(s) and the copyright owner(s) are credited and that the original patients/learn-about-drug-and-device-approvals/fast-track-breakthrough- publication in this journal is cited, in accordance with accepted academic practice. No therapy-accelerated-approval-priority-review. use, distribution or reproduction is permitted which does not comply with these terms. Frontiers in Pharmacology | www.frontiersin.org 2 May 2020 | Volume 11 | Article 766