A literature review was conducted with the expression “Accelerated assessment”, in English and in French between the 29 and 31 August 2022, in the following databases: Dalloz, HeinOnline, Lexbase, Lexis Nexis, Lextenso, Navis, Doctrinal Plus, Westlaw UK, Brill and Cairn, Bibliothèque numérique en droit de la santé, Wiley Online Library, Lamyline Reflex, Cambridge University Press Revues – Archives ISTEX, De Gruyter revues – Archives ISTEX, Encyclopédie Max Planck de droit international public, JSTOR, Law Review Commons, OpenEdition Journals, ScienceDirect, Springer Nature, Web of Science, Google Scholar and PubMed.
Please find below the most relevant results of this review.
Antoñanzas, F., C. A. Juárez-Castelló, and R. Rodríguez-Ibeas. « EMA Priority Medicines Scheme (PRIME): Will More Paying-for-Performance Agreements Be Needed Due to Immature Data? » The European Journal of Health Economics 19, no 7 (2018): 905‑907.
Baird, L G, R Banken, H-G Eichler, F B Kristensen, D K Lee, J C W Lim, R Lim, and al. « Accelerated Access to Innovative Medicines for Patients in Need ». Clinical Pharmacology & Therapeutics 96, no 5 (2014): 559‑571.
https://doi.org/10.1038/clpt.2014.145.
Baran-Kooiker, Aleksandra, Marcin Czech, and Coen Kooiker. « Overview of regulatory initiatives in the European Union to stimulate research and accelerate access to orphan drugs and other high medical need products ». Acta Poloniae Pharmaceutica – Drug Research 76, no 1 (28 February 2019): 3‑17.
https://doi.org/10.32383/appdr/93138.
Boucaud-Maitre, Denis, and Jean-Jacques Altman. « Do the EMA Accelerated Assessment Procedure and the FDA Priority Review Ensure a Therapeutic Added Value? 2006–2015: A Cohort Study ». European Journal of Clinical Pharmacology 72, no 10 (1st October 2016): 1275‑1281.
https://doi.org/10.1007/s00228-016-2104-3.
Costa Gonçalves, Fabiany da, Ebru Demirci, and Alex Zwiers. « A Detailed Analysis of Expedited Regulatory Review Time of Marketing Authorization Applications for New Anticancer Drugs in the US and EU ». Clinical and Translational Science 15, no 8 (2022): 1959‑1967.
https://doi.org/10.1111/cts.13308.
Cox, Erica M., Anita V. Edmund, Erica Kratz, Sarah H. Lockwood, and Aishwarya Shankar. « Regulatory Affairs 101: Introduction to Expedited Regulatory Pathways ». Clinical and Translational Science 13, no 3 (2020): 451‑461. https://doi.org/10.1111/cts.12745.
Detela, Giulia, and Anthony Lodge. « EU Regulatory Pathways for ATMPs: Standard, Accelerated and Adaptive Pathways to Marketing Authorisation ». Molecular Therapy – Methods & Clinical Development 13 (14 June 2019): 205‑232. https://doi.org/10.1016/j.omtm.2019.01.010.
Drago, Daniela, Betsy Foss-Campbell, Keith Wonnacott, David Barrett, and Adora Ndu. « Global Regulatory Progress in Delivering on the Promise of Gene Therapies for Unmet Medical Needs ». Molecular Therapy – Methods & Clinical Development 21 (11 June 2021): 524‑529.
https://doi.org/10.1016/j.omtm.2021.04.001.
Elsanhoury, Ahmed, Ralf Sanzenbacher, Petra Reinke, and Mohamed Abou-El-Enein. « Accelerating Patients’ Access to Advanced Therapies in the EU ». Molecular Therapy – Methods & Clinical Development 7 (15 December 2017): 15‑19.
https://doi.org/10.1016/j.omtm.2017.08.005.
Gannedahl, Mia, Amina Udechuku, and Matthew W Bending. « Initiatives Driving Accelerated Access to Medicines in Europe: Review of Recent Concepts and Developments ». Medicine Access @ Point of Care 2 (1st January 2018): 1-7.
https://doi.org/10.1177/2399202618761854.
Garsen, Marjolein, Maaike Steenhof, and Alex Zwiers. « A Decade of Marketing Authorization Applications of Anticancer Drugs in the European Union: An Analysis of Procedural Timelines ». Therapeutic Innovation & Regulatory Science 55, no 4 (1st July 2021): 633‑642.
https://doi.org/10.1007/s43441-021-00260-5.
Gonen, Galit. « Innovation in Known Drugs – The European Angle Symposium 2017 ». Washington Journal of Law, Technology & Arts 12, no 3 (2017 2016): 253‑292.
Huckle, Richard. « The Need for Speed – Enhancing Treatment Access for Unmet Needs ». Regulatory Rapporteur 16, no 1 (January 2019): 7.
Iglesias-Lopez, Carolina, Mercè Obach, Antonio Vallano, and Antonia Agustí. « Comparison of Regulatory Pathways for the Approval of Advanced Therapies in the European Union and the United States ». Cytotherapy 23, no 3 (1st March 2021): 261‑274.
https://doi.org/10.1016/j.jcyt.2020.11.008.
Martinalbo, J., D. Bowen, J. Camarero, M. Chapelin, P. Démolis, P. Foggi, B. Jonsson, and al. « Early Market Access of Cancer Drugs in the EU ». Annals of Oncology 27, no 1 (1st January 2016): 96‑105.
https://doi.org/10.1093/annonc/mdv506.
Nicotera, Giuseppe, Gianluca Sferrazza, Anna Lucia Serafino, and Pasquale Pierimarchi. « The Iterative Development of Medicines Through the European Medicine Agency’s Adaptive Pathway Approach ». Frontiers in Medicine 6 (2019).
https://www.frontiersin.org/articles/10.3389/fmed.2019.00148.
Parviainen, L, W Belgaied, Y Sediri, B Haijeji, C Rémuzat, and M Toumi. « PHP168 – Early Market Access for Pharmaceuticals in EU: What Is the Impact of Ema’s Accelerated Assessment Procedure? » Value in Health 19, no 7 (1st November 2016): A469.
https://doi.org/10.1016/j.jval.2016.09.710.
Scavone, Cristina, Gabriella di Mauro, Annamaria Mascolo, Liberato Berrino, Francesco Rossi, and Annalisa Capuano. « The New Paradigms in Clinical Research: From Early Access Programs to the Novel Therapeutic Approaches for Unmet Medical Needs ». Frontiers in Pharmacology 10 (2019). https://www.frontiersin.org/articles/10.3389/fphar.2019.00111.
Shah, Rashmi R., Samantha A. Roberts, and Devron R. Shah. « A Fresh Perspective on Comparing the FDA and the CHMP/EMA: Approval of Antineoplastic Tyrosine Kinase Inhibitors ». British Journal of Clinical Pharmacology 76, no 3 (2013): 396‑411.
https://doi.org/10.1111/bcp.12085.
Simpson, Shmona, Ajoy Chakrabarti, David Robinson, Keith Chirgwin, and Murray Lumpkin. « Navigating Facilitated Regulatory Pathways during a Disease X Pandemic ». Npj Vaccines 5, no 1 (23 October 2020): 1‑9.
https://doi.org/10.1038/s41541-020-00249-5.
Van Delm, Kaat. « Accelerated Access to Medicinal Products ». European Pharmaceutical Law Review (EPLR) 4, no 4 (2020): 192‑206.
Wang, Shuhang, Qiuyan Yang, Lan Deng, Qi Lei, Yuqi Yang, Peiwen Ma, Yuxin Men, and al. « An Overview of Cancer Drugs Approved through Expedited Approval Programs and Orphan Medicine Designation Globally between 2011 and 2020 ». Drug Discovery Today 27, no 5
(1st May 2022): 1236‑1250. https://doi.org/10.1016/j.drudis.2021.12.021.