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Conditional Marketing Authorisation

A literature review was conducted with the expression “Conditional marketing authorisation”, in English and in French between the 13 and 20 September 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.

Abbas, Nasir, and Zaheer-Ud-Din Babar. « Marketing Authorization of COVID-19 Vaccines across UK, EU, and the US: Fact-Checking and the Implications for Future Research ». Journal of Pharmaceutical Policy and Practice 14, no 1 (24 December 2021): 1-4. https://doi.org/10.1186/s40545-021-00400-0.

Banzi, Rita, Chiara Gerardi, Vittorio Bertele’, and Silvio Garattini. « Approvals of Drugs with Uncertain Benefit–Risk Profiles in Europe ». European Journal of Internal Medicine 26, no 8 (1st October 2015): 572‑584.
https://doi.org/10.1016/j.ejim.2015.08.008.

Banzi, Rita, Chiara Gerardi, Vittorio Bertele’, and Silvio Garattini. « Conditional Approval of Medicines by the EMA ». BMJ 357 (2 May 2017): 1-2.
https://doi.org/10.1136/bmj.j2062.

Baumevieille, Marie, and Catherine Maurin. « Autorisation de mise sur le marché des médicaments – Développement de l’offre et autorisation de mise sur le marché des médicaments dans l’Union européenne ». Propriété industrielle, no 1 (1st January 2009).

Bloem, Lourens T., Aukje K. Mantel-Teeuwisse, Hubert G. M. Leufkens, Marie L. De Bruin, Olaf H. Klungel, and Jarno Hoekman. « Postauthorization Changes to Specific Obligations of Conditionally Authorized Medicines in the European Union: A Retrospective Cohort Study ». Clinical Pharmacology & Therapeutics 105, no 2 (February 2019): 426‑435. https://doi.org/10.1002/cpt.1169.

Cavaleri, Marco, Harald Enzmann, Sabine Straus, and Emer Cooke. « The European Medicines Agency’s EU Conditional Marketing Authorisations for COVID-19 Vaccines ». The Lancet 397, no 10272 (30 January 2021): 355‑357. https://doi.org/10.1016/S0140-6736(21)00085-4.

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.

Donati, Alessandra. « The Conditional Marketing Authorisation of Covid-19 Vaccines: A Critical Assessment under EU Law ». European Journal of Health Law 29, no 1 (4 March 2022): 33‑52.
https://doi.org/10.1163/15718093-bja10065.

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.

Hemmings, Robert James. « Conditional Approval: Discussion Points from the PSI Conditional Approval Expert Group – Rejoinder from the Regulator ». Pharmaceutical Statistics 7, no 4 (10 September 2008): 270‑271.
https://doi.org/10.1002/pst.308.

Herold, Ralf, Jorge Camarero, Daniela Melchiorri, Zigmars Sebris, Harald Enzmann, and Francesco Pignatti. « Revocation of the Conditional Marketing Authorisation of a Cancer Medicine: The Olaratumab Experience ». European Journal of Cancer 123 (1st December 2019): 25‑27.
https://doi.org/10.1016/j.ejca.2019.09.020.

Hoekman, J, Wpc Boon, Jc Bouvy, Hc Ebbers, Jp de Jong, and Ml De Bruin. « Use of the Conditional Marketing Authorization Pathway for Oncology Medicines in Europe ». Clinical Pharmacology & Therapeutics 98, no 5 (November 2015): 534‑541. https://doi.org/10.1002/cpt.174.

Hoekman, Jarno, and Wouter Boon. « Changing Standards for Drug Approval: A Longitudinal Analysis of Conditional Marketing Authorisation in the European Union ». Social Science & Medicine 222 (1st February 2019): 76‑83.
https://doi.org/10.1016/j.socscimed.2018.12.025.

Hoekman, Jarno, Thea T. Klamer, Aukje K. Mantel-Teeuwisse, Hubert G. M. Leufkens, and Marie L. De Bruin. « Characteristics and Follow-up of Postmarketing Studies of Conditionally Authorized Medicines in the EU ». British Journal of Clinical Pharmacology 82, no 1 (2016): 213‑226.
https://doi.org/10.1111/bcp.12940.

Job, Jean-Marie. « Produits issus du corps humain, produits de santé et produits alimentaires ». Gazette du Palais, no 343 (9 December 2006): 51.

Jokura, Yoji, Kazuo Yano, and Masayuki Yamato. « Comparison of the New Japanese Legislation for Expedited Approval of Regenerative Medicine Products with the Existing Systems in the USA and European Union ». Journal of Tissue Engineering and Regenerative Medicine 12, no 2 (2018): e1056‑e1062. https://doi.org/10.1002/term.2428.

Lipska, I, J Hoekman, N McAuslane, Hgm Leufkens, and Am Hövels. « Does Conditional Approval for New Oncology Drugs in Europe Lead to Differences in Health Technology Assessment Decisions? » Clinical Pharmacology & Therapeutics 98, no 5 (November 2015): 489‑491.
https://doi.org/10.1002/cpt.198.

Mariz, Segundo, Stelios Tsigkos, Laura Fregonese, Stiina Aarum, Eleonora Dehlink, Jordi Llinares, and Bruno Sepodes. « The Orphan Framework as a New Opportunity: An Expert Opinion ». Expert Opinion on Orphan Drugs 2, no 11 (1st November 2014): 1181‑1186.
https://doi.org/10.1517/21678707.2014.973849.

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.

Mégerlin, Francis. « L’AMM conditionnelle issue du règlement communautaire n° 507/2006 et l’urgence de santé publique ». Revue de Droit Sanitaire et Social, no 4 (10 July 2006): 691‑703.

Mills, Mackenzie, and Panos Kanavos. « How Do HTA Agencies Perceive Conditional Approval of Medicines? Evidence from England, Scotland, France and Canada ». Health Policy, (9 August 2022):14.
https://doi.org/10.1016/j.healthpol.2022.08.005.

Naesens, Maarten, Alexandre Loupy, Luuk Hilbrands, Rainer Oberbauer, Maria Irene Bellini, Denis Glotz, Josep Grinyó, and al. « Rationale for Surrogate Endpoints and Conditional Marketing Authorization of New Therapies for Kidney Transplantation ». Transplant International, 35, (May 2022): 1-9.
https://doi.org/10.3389/ti.2022.10137.

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.

Protin, Ursula. « First experiences with Conditional Marketing Authorisations in the EU: requirements, obligations, initial experiences and perspectives ». Rheinischen Friedrich-Wilhelms-Universität Bonn, 2007.

Roncati, Luca, and Monica Roncati. « Emergency Use Authorization (EUA), Conditional Marketing Authorization (CMA), and the Precautionary Principle at the Time of COVID-19 Pandemic ». Journal of Public Health Policy 42, no 3 (1st September 2021): 518‑521.
https://doi.org/10.1057/s41271-021-00299-6.

Salcher-Konrad, Maximilian, Huseyin Naci, and Courtney Davis. « Approval of Cancer Drugs With Uncertain Therapeutic Value: A Comparison of Regulatory Decisions in Europe and the United States ». The Milbank Quarterly 98, no 4 (2020): 1219‑1256. https://doi.org/10.1111/1468-0009.12476.

Stebbing, Justin, Christopher Wood, Michael Atkins, Ronald Bukowski, Stephen Litwin, Mark Bower, Andrew Parsa, and Hyam Levitsky. « Cancer Vaccines: Clinical Development Challenges and Proposed Regulatory Approaches for Patient Access to Promising Treatments ». Cancer 112, no 5 (1st March 2008): 955‑961. https://doi.org/10.1002/cncr.23273.

Stratford, Jemima, Emily MacKenzie, and Emma Mockford. « Balancing Speed and Safety: The Authorisation of Covid-19 Vaccines and Medicines ». Judicial Review 25, no 2 (2 April 2020): 105‑117.
https://doi.org/10.1080/10854681.2020.1780664.

Van Delm, Kaat. « Accelerated Access to Medicinal Products ». European Pharmaceutical Law Review (EPLR) 4, no 4 (2020): 192‑206.

Vella Bonanno, Patricia, Michael Ermisch, Brian Godman, Antony P. Martin, Jesper Van Den Bergh, Liudmila Bezmelnitsyna, Anna Bucsics, and al. « Adaptive Pathways: Possible Next Steps for Payers in Preparation for Their Potential Implementation ». Frontiers in Pharmacology, 8 (23 August 2017): 1-13.
https://www.frontiersin.org/articles/10.3389/fphar.2017.00497.

Vreman, Rick A., Jacoline C. Bouvy, Lourens T. Bloem, Anke M. Hövels, Aukje K. Mantel-Teeuwisse, Hubert G.M. Leufkens, and Wim G. Goettsch. « Weighing of Evidence by Health Technology Assessment Bodies: Retrospective Study of Reimbursement Recommendations for Conditionally Approved Drugs ». Clinical Pharmacology & Therapeutics 105, no 3 (March 2019): 684‑691.
https://doi.org/10.1002/cpt.1251.

Waleszczak, Sarah. « Battle of the Regulators: Comparing FDA’s Accelerated Approval and EMA’s Conditional Marketing Authorisation ». ProPharma Group, (22 February 2022) : 1-4.
https://www.propharmagroup.com/blog/comparing-fdas-accelerated-approval-and-emas-conditional-marketing-authorisation/.

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.