A bibliographic research was conducted with the expression “Scientific Advice”, in English and in French from 28 to 29 April 2025, in the following databases: Dalloz, HeinOnline, Lexbase, Lexis 360, Lextenso, Navis, Le Doctrinal, Cairn revues, Bibliothèque numérique en droit de la santé, Lamyline Reflex, OpenEdition Journals and PubMed.
Please find below the most relevant results of this review:
Broz, Daniela Kenzelmann, Gabriele Galliverti, and Anja Buhrer. ‘Scientific Advice Procedures in the EU – an Overview of the Regulatory Background’. Medical Writing 29, no. 3 (September 2020): 36–45.
Elsäßer, Amelie, Jan Regnstrom, Thorsten Vetter, Franz Koenig, Robert James Hemmings, Martina Greco, Marisa Papaluca-Amati, and Martin Posch. ‘Adaptive Clinical Trial Designs for European Marketing Authorization: A Survey of Scientific Advice Letters from the European Medicines Agency’. Trials 15, no. 1 (2 October 2014): 383.
https://doi.org/10.1186/1745-6215-15-383
Hanaizi, Zahra, Sandra Kweder, Shannon Thor, Sonia Ribeiro, and Anabela Marcal. ‘Considering Global Development? Insights from Applications for FDA Breakthrough Therapy and EMA PRIME Designations’. Therapeutic Innovation & Regulatory Science 57, no. 2 (1 March 2023): 321–328.
https://doi.org/10.1007/s43441-022-00475-0
Hofer, Matthias P., Hanna Hedman, Maria Mavris, Franz Koenig, Thorsten Vetter, Martin Posch, Spiros Vamvakas, Jan Regnstrom, and Stiina Aarum. ‘Marketing Authorisation of Orphan Medicines in Europe from 2000 to 2013’. Drug Discovery Today 23, no. 2 (1 February 2018): 424–433.
https://doi.org/10.1016/j.drudis.2017.10.012
Huber, Cynthia, Joerg Zinserling, Norbert Benda, Thorsten Vetter, and Marcia Rueckbeil. ‘Methodological Insights on Biomarker-Based Patient Selection: A Review of Scientific Advice Procedures at the European Medicines Agency’. Clinical Pharmacology & Therapeutics 117, no. 5 (2025): 1226–1235.
https://doi.org/10.1002/cpt.3558
Jilma, Bernd. ‘Development of Advanced Therapy Medicinal Products — a Case for Early Scientific Advice’. In Clinical Pharmacology: Current Topics and Case Studies, 323–334. Springer, Vienna, 2010.
https://doi.org/10.1007/978-3-7091-0144-5_21
Jost, Nils, Martina Schüssler-Lenz, Bettina Ziegele, and Jens Reinhardt. ‘[Scientific advice by the national and European approval authorities concerning advanced therapy medicinal products]’. Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz 58, no. 11–12 (November 2015): 1207–1214.
https://doi.org/10.1007/s00103-015-2236-0
Kenzelmann Broz, Daniela, Gabriele Galliverti, and Anja Buhrer. ‘Scientific Advice Procedures in the EU – an Overview of the Regulatory Background’. Medical Writing 29, no. 3 (September 2020): 36–45.
Manolis, Efthymios, Spiros Vamvakas, and Maria Isaac. ‘New Pathway for Qualification of Novel Methodologies in the European Medicines Agency’. PROTEOMICS – Clinical Applications 5, no. 5–6 (2011): 248–255.
https://doi.org/10.1002/prca.201000130
Moseley, Jane, Spiros Vamvakas, Michael Berntgen, Alison Cave, Xavier Kurz, Peter Arlett, Virginia Acha, et al. ‘Regulatory and Health Technology Assessment Advice on Postlicensing and Postlaunch Evidence Generation Is a Foundation for Lifecycle Data Collection for Medicines’. British Journal of Clinical Pharmacology 86, no. 6 (2020): 1034–1051.
Putzeist, Michelle, Aukje K. Mantel-Teeuwisse, Christine C. Gispen-De Wied, Arno W. Hoes, and Hubert G. Leufkens. ‘Regulatory Scientific Advice in Drug Development: Does Company Size Make a Difference?’ European Journal of Clinical Pharmacology 67, no. 2 (1 February 2011): 157–164.
https://doi.org/10.1007/s00228-010-0919-x
Troostenburg, Anne-Ruth van, Giuliana Tabusso, and Enrico Bosone. ‘Scientific Advice and Protocol Assistance by the EMEA’. International Journal of Pharmaceutical Medicine 20, no. 4 (1 August 2006): 227–231.
https://doi.org/10.2165/00124363-200620040-00002
Van Delm, Kaat. ‘Accelerated Access to Medicinal Products’. European Pharmaceutical Law Review (EPLR) 4, no. 4 (2020): 192–206.
https://doi.org/10.21552/eplr/2020/4/4
