A bibliographic research was conducted with the expression “Parallel Scientific Advice”, in English and in French from 4 to 25 February 2025, in the following databases: Dalloz, HeinOnline, Lexbase, Lexis 360, Lextenso, Navis, Le Doctrinal, Brill revues – Archives ISTEX, Cairn revues, 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:
Arcidiacono, Judith. ‘International Harmonization for Cell and Gene Therapy Products’. In Regulatory Aspects of Gene Therapy and Cell Therapy Products, 235–240. Springer, Cham, 2023.
https://doi.org/10.1007/978-3-031-34567-8_14
Arcidiacono, Judith A., Joan W. Blair, and Kimberly A. Benton. ‘US Food and Drug Administration International Collaborations for Cellular Therapy Product Regulation’. Stem Cell Research & Therapy 3, no. 5 (December 2012): 1–5.
https://doi.org/10.1186/scrt129
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
Bergmann, L., H. Enzmann, S. Thirstrup, J. K. Schweim, I. Widera, and H. Zwierzina. ‘Access to Innovative Oncology Medicines in Europe’. Annals of Oncology 27, no. 2 (1 February 2016): 353–356.
https://doi.org/10.1093/annonc/mdv547
Boss, J., A. Sood, M. Mujoomdar, P. Hurley, and M. Bending. ‘PNS250 CADTH Parallel Scientific Advice Programs with NICE and Health Canada’. Value in Health 22 (1 November 2019): S804. https://doi.org/10.1016/j.jval.2019.09.2150
Colloud, Seya, Thomas Metcalfe, Scott Askin, Shibeshih Belachew, Johannes Ammann, Ernst Bos, Timothy Kilchenmann, and al. ‘Evolving Regulatory Perspectives on Digital Health Technologies for Medicinal Product Development’. Npj Digital Medicine 6, no. 1 (29 March 2023): 1–11.
https://doi.org/10.1038/s41746-023-00790-2
Dunger-Baldauf, Cornelia, Rob Hemmings, Frank Bretz, Byron Jones, Anja Schiel, and Chris Holmes. ‘Generating the Right Evidence at the Right Time: Principles of a New Class of Flexible Augmented Clinical Trial Designs’. Clinical Pharmacology & Therapeutics 113, no. 5 (2023): 1132–1138.
https://doi.org/10.1002/cpt.2869
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
Isaac, Maria, and Christine Gispen-de Wied. ‘CNS Biomarkers: Potential from a Regulatory Perspective: Case Study – Focus in Low Hippocampus Volume as a Biomarker Measured by MRI’. European Neuropsychopharmacology, What regulatory science can bring for CNS drug development, 25, no. 7 (1 July 2015): 1003–1009.
https://doi.org/10.1016/j.euroneuro.2015.03.013
Kluetz, Paul G, Daniel J O’Connor, and Katherine Soltys. ‘Incorporating the Patient Experience into Regulatory Decision Making in the USA, Europe, and Canada’. The Lancet Oncology 19, no. 5 (1 May 2018): e267–274.
https://doi.org/10.1016/S1470-2045(18)30097-4
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 (1 November 2014): 1181–1186.
https://doi.org/10.1517/21678707.2014.973849
Putzeist, Michelle, Harald E. Heemstra, Jordi Llinares Garcia, Aukje K. Mantel-Teeuwisse, Christine C. Gispen-De Wied, Arno W. Hoes, and Hubert G. M. Leufkens. ‘Determinants for Successful Marketing Authorisation of Orphan Medicinal Products in the EU’. Drug Discovery Today 17, no. 7 (1 April 2012): 352–358.
https://doi.org/10.1016/j.drudis.2011.10.027
Seimetz, Diane, Karl Heller, and Jan Richter. ‘Approval of First CAR-Ts: Have We Solved All Hurdles for ATMPs?’ Cell Medicine 11 (1 January 2019): 2155179018822781.
https://doi.org/10.1177/2155179018822781
Stacchiotti, Silvia, Gauthier Bouche, Ralf Herold, Pan Pantziarka, Kathrin Schuster, Roger Wilson, Francesco Pignatti, and Bernd Kasper. ‘How to Develop New Systemic Treatments in Ultra-Rare Cancers with High Unmet Needs? The Case of Alveolar Soft-Part Sarcoma’. European Journal of Cancer 202 (1 May 2024): 114003.
https://doi.org/10.1016/j.ejca.2024.114003
Teixeira, Tania, Sandra L. Kweder, and Agnes Saint-Raymond. ‘Are the European Medicines Agency, US Food and Drug Administration, and Other International Regulators Talking to Each Other?’ Clinical Pharmacology & Therapeutics 107, no. 3 (2020): 507–513.
https://doi.org/10.1002/cpt.1617
Thomsen, Mette Due Theilade. ‘Global Pediatric Drug Development’. Current Therapeutic Research 90 (1 January 2019): 135–142.
https://doi.org/10.1016/j.curtheres.2019.02.001
Thor, Shannon, Thorsten Vetter, Anabela Marcal, and Sandra Kweder. ‘EMA-FDA Parallel Scientific Advice: Optimizing Development of Medicines in the Global Age’. Therapeutic Innovation & Regulatory Science 57, no. 4 (1 July 2023): 656–661.
https://doi.org/10.1007/s43441-023-00501-9
Vamvakas, Spiros, Jane Moseley, and Thorsten Vetter. ‘Multistakeholder Advice at the European Medicines Agency: Is It Still Needed?’ Clinical Pharmacology & Therapeutics 105, no. 4 (2019): 819–821.
https://doi.org/10.1002/cpt.1335
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
Zagalo, Daniela M., Sérgio Simões, and João Sousa. ‘Regulatory Science Approach in Pharmaceutical Development of Follow-on Versions of Non-Biological Complex Drug Products’. Journal of Pharmaceutical Sciences 111, no. 10 (1 October 2022): 2687–2713.
https://doi.org/10.1016/j.xphs.2022.07.015
