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Marketing Authorisation under Exceptional Circumstances

A literature review was conducted with the expression “Marketing authorisation under exceptional circumstances”, in English and in French between the 18 and 19 October 2022, in the following databases: Dalloz, HeinOnline, Lexbase, Lexis Nexis, Lextenso, Navis, Doctrinal Plus, Westlaw UK, Brill, 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.

Boon, W P C, E H M Moors, A Meijer, and H Schellekens. “Conditional Approval and Approval Under Exceptional Circumstances as Regulatory Instruments for Stimulating Responsible Drug Innovation in Europe”. Clinical Pharmacology & Therapeutics 88, no 6 (December 2010): 848‑853.
https://doi.org/10.1038/clpt.2010.207.

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.

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.

Meier, A, Sd Faulkner, C Schoonderbeek, B Jong, J Kung, D Brindley, and R Barker. “An Assessment of Implications of Adaptive Licensing for Pharmaceutical Intellectual Property and Regulatory Exclusivity Rights in the European Union”. Clinical Pharmacology & Therapeutics 100, no 6 (December 2016): 743‑753. https://doi.org/10.1002/cpt.511.

Neez, E., H. Naci, P. Pinilla, L. Osipenko, and E. Mossialos. “Implications of Conditional Approval and Approval under Exceptional Circumstances by the European Medicines Agency on NICE Appraisals – PHP 290”. Value in Health, ISPOR Europe 2018: New Perspectives for Improving 21st Century Health Systems, 21 (1st October 2018): S199. https://doi.org/10.1016/j.jval.2018.09.1184.

Netzer, Tilo. “European Union Centralised Procedure for Marketing Authorisation of Oncology Drugs: An in-Depth Review of Its Efficiency”. European Journal of Cancer 42, no 4 (March 2006): 446‑455. https://doi.org/10.1016/j.ejca.2005.04.045.

Nicotera, Giuseppe, Gianluca Sferrazza, Annalucia Serafino, and Pasquale Pierimarchi. “The Iterative Development of Medicines Through the European Medicine Agency’s Adaptive Pathway Approach”. Frontiers in Medicine 6 (27 June 2019) : 1-10. https://doi.org/10.3389/fmed.2019.00148.

Nisticò, Giuseppe. “Orphan Drugs Assessment in the Centralised Procedure”. Annali Dell Istituto Superiore Di Sanita Vol. 47, no 1: 98-99 (2011): 1-2. https://doi.org/10.4415/aNN_11_01_19.

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.

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.