A bibliographic research was conducted with the expression “Joint Scientific Consultation”, in English and in French from 24 to 25 March 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:
Brinkhuis, Francine, Elaine Julian, Hendrika van den Ham, Fabrizio Gianfrate, Valentina Strammiello, Michael Berntgen, Mira Pavlovic, and al. ‘Navigating the Path towards Successful Implementation of the EU HTA Regulation: Key Takeaways from the 2023 Spring Convention of the European Access Academy’. Health Research Policy and Systems 22, no. 1 (December 2024): 1–12.
https://doi.org/10.1186/s12961-024-01154-2
Brinkhuis, Francine, Jörg Ruof, Hendrika van den Ham, Fabrizio Gianfrate, Valentina Strammiello, Michael Berntgen, Mira Pavlovic, and al. ‘Evaluating Progress towards Implementation of the European HTA Regulation: Insights Generated from the European Access Academy’s Multi-Stakeholder Survey’. Health Policy and Technology 13, no. 5 (1 November 2024): 100930.
https://doi.org/10.1016/j.hlpt.2024.100930
Burns, Leah, Nadege Le Roux, Robert Kalesnik-Orszulak, Jennifer Christian, Jennifer Dudinak, Frank Rockhold, Sean Khozin, and John O’Donnell. ‘Real-World Evidence for Regulatory Decision-Making: Updated Guidance from around the World’. Frontiers in Medicine 10 (30 October 2023).
https://doi.org/10.3389/fmed.2023.1236462
Ciani, Oriana, and Claudio Jommi. ‘The Role of Health Technology Assessment Bodies in Shaping Drug Development’. Drug Design, Development and Therapy 8 (10 November 2014): 2273–2281.
https://doi.org/10.2147/DDDT.S49935
Curtis, Lesley H., Oriol Sola-Morales, Julien Heidt, Patrick Saunders-Hastings, Laura Walsh, Deborah Casso, Susan Oliveria, and al. ‘Regulatory and HTA Considerations for Development of Real-World Data Derived External Controls’. Clinical Pharmacology & Therapeutics 114, no. 2 (2023): 303–315.
https://doi.org/10.1002/cpt.2913
D’Ausilio, A., R. Arora, C. Delaitre-Bonnin, and M. W. Bending. ‘A Review of the Differences Between the New Emaeunethta Joint Scientific Consultation Versus the Previous Ema-Hta Parallel Scientific Consultation’. Value In Health 26, no. 12 (December 2023): S360–S360.
Dekker, Marieke J. H. J., Jacoline C. Bouvy, Diana O’Rourke, Robin Thompson, Amr Makady, Pall Jonsson, and Christine C. Gispen-de Wied. ‘Alignment of European Regulatory and Health Technology Assessments: A Review of Licensed Products for Alzheimer’s Disease’. Frontiers in Medicine 6 (7 May 2019).
https://doi.org/10.3389/fmed.2019.00073
Desmet, Thomas, Maud Brijs, Frank Vanderdonck, Sven Tops, Steven Simoens, and Isabelle Huys. ‘Implementing the EU HTA Regulation: Insights from Semi-Structured Interviews on Patient Expectations, Belgian and European Institutional Perspectives, and Industry Outlooks’. Frontiers In Pharmacology 15 (10 April 2024): 1369508.
https://doi.org/10.3389/fphar.2024.1369508
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
Drummond, Michael, Rosanna Tarricone, and Aleksandra Torbica. ‘European Union Regulation of Health Technology Assessment: What Is Required for It to Succeed?’ The European Journal of Health Economics 23, no. 6 (1 August 2022): 913–915.
https://doi.org/10.1007/s10198-022-01458-6
Ehmann, Falk, Laura Caneva, and Marisa Papaluca. ‘European Medicines Agency Initiatives and Perspectives on Pharmacogenomics’. British Journal of Clinical Pharmacology 77, no. 4 (2014): 612–617.
https://doi.org/10.1111/bcp.12319
Elvidge, Suzanne. ‘EMA’s Parallel Advice Workshop Bridges Regulatory and Reimbursement Divide’. Nature Reviews Drug Discovery 13, no. 8 (31 December 2013): 8–8.
https://doi.org/10.1038/nrd4219
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 (1 January 2018): 2399202618761854.
https://doi.org/10.1177/2399202618761854
Ibargoyen-Roteta, Nora, Lorea Galnares-Cordero, Gaizka Benguria-Arrate, Kelly Rocío Chacón-Acevedo, María Paula Gutiérrez-Sepulveda, Eduardo Low-Padilla, Ilich Herbert De La Hoz-Siegler, and al. ‘A Systematic Review of the Early Dialogue Frameworks Used within Health Technology Assessment and Their Actual Adoption from HTA Agencies’. Frontiers in Public Health 10 (6 October 2022).
https://doi.org/10.3389/fpubh.2022.942230
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 (1 March 2021): 261–274.
https://doi.org/10.1016/j.jcyt.2020.11.008
Jansen, Ella, Philip A. Hines, Michael Berntgen, and Angela Brand. ‘Strengthening the Interface of Evidence-Based Decision Making Across European Regulators and Health Technology Assessment Bodies’. Value in Health 25, no. 10 (1 October 2022): 1726–1735.
https://doi.org/10.1016/j.jval.2022.01.026
Khan, Saima, and Monique Carter. ‘European Medicines Agency-Health Technology Assessment Parallel Consultation Platform: An Industry Perspective’. Clinical Pharmacology & Therapeutics 105, no. 4 (2019): 822–825.
https://doi.org/10.1002/cpt.1337
Karres, Dominik, María José Pino-Barrio, Sylvie Benchetrit, Norbert Benda, Pierre Cochat, Sara Galluzzo, Alejandro García-Solís, and al. ‘Evidence Generation throughout Paediatric Medicines Life Cycle: Findings from Collaborative Work between European Medicines Agency (EMA) and EUnetHTA on Use of Extrapolation’. British Journal of Pharmacology 182, no. 3 (2025): 484–494.
https://doi.org/10.1111/bph.17396
Madrid Paredes, Jorge, Jan-Willem Versteeg, Rick A. Vreman, and Lourens T. Bloem. ‘Agreement about Availability of Alternative Treatments for Innovative Drugs Assessed by the EMA and HTA Organizations’. Clinical Pharmacology & Therapeutics 116, no. 1 (2024): 136–146.
https://doi.org/10.1002/cpt.3252
Maignen, François, Leeza Osipenko, Pilar Pinilla-Dominguez, and Emily Crowe. ‘Integrating Health Technology Assessment Requirements in the Clinical Development of Medicines: The Experience from NICE Scientific Advice’. European Journal of Clinical Pharmacology 73, no. 3 (1 March 2017): 297–305.
https://doi.org/10.1007/s00228-016-2174-2
‘Outcomes of Early Health Technology Assessment Dialogues in Medicinal Product Development’. News. Nature Reviews Drug Discovery. Nature Publishing Group, 2 February 2017.
https://doi.org/10.1038/nrd.2016.286
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 (1 January 2016): 96–105.
https://doi.org/10.1093/annonc/mdv506
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.
https://doi.org/10.1111/bcp.14279
Mueller, E., and K. Neeser. ‘Joint Scientific Consultation (Jsc) and Joint Clinical Assessment (Jca) – a Better Road to Access?’ Value In Health 25, no. 12 (December 2022): S262–S262.
Nature Reviews Drug Discovery. ‘EMA Publishes Parallel Scientific Advice’. News. Nature Publishing Group, 30 May 2014.
https://doi.org/10.1038/nrd4358
Ng, T., J. Ziomek, C. Delaitre-Bonnin, and M. W. Bending. ‘PHP276 – A review of the impact of integrated scientific advice for the optimisation of evidence generation for HTA appraisals’. Value in Health 21 (1 October 2018): S197.
https://doi.org/10.1016/j.jval.2018.09.1170
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).
https://doi.org/10.3389/fmed.2019.00148
Ofori-Asenso, Richard, Christine E. Hallgreen, and Marie Louise De Bruin. ‘Improving Interactions Between Health Technology Assessment Bodies and Regulatory Agencies: A Systematic Review and Cross-Sectional Survey on Processes, Progress, Outcomes, and Challenges’. Frontiers in Medicine 7 (16 October 2020).
https://doi.org/10.3389/fmed.2020.582634
Papagiannopoulos, C., M. Nascimento, H. Marques, J. Mulchande, and E. Gonçalves. ‘HTA102 Early Scientific Advice in Europe: An Overview of Processes and Requirements’. Value in Health 26, no. 6 (1 June 2023): S277.
https://doi.org/10.1016/j.jval.2023.03.2668
Qiu, Tingting, Shuyao Liang, Yitong Wang, Claude Dussart, Borislav Borissov, and Mondher Toumi. ‘Reinforcing Collaboration and Harmonization to Unlock the Potentials of Advanced Therapy Medical Products: Future Efforts Are Awaited From Manufacturers and Decision-Makers’. Frontiers in Public Health 9 (25 November 2021).
https://doi.org/10.3389/fpubh.2021.754482
Tafuri, Giovanni, Inês Lucas, Steve Estevão, Jane Moseley, Anne d’Andon, Hannah Bruehl, Elangovan Gajraj, and al. ‘The Impact of Parallel Regulatory–Health Technology Assessment Scientific Advice on Clinical Development. Assessing the Uptake of Regulatory and Health Technology Assessment Recommendations’. British Journal of Clinical Pharmacology 84, no. 5 (2018): 1013–1019.
https://doi.org/10.1111/bcp.13524
Tafuri, Giovanni, Margherita Pagnini, Jane Moseley, Marco Massari, Frank Petavy, Antje Behring, Arantxa Catalan, and al. ‘How Aligned Are the Perspectives of EU Regulators and HTA Bodies? A Comparative Analysis of Regulatory-HTA Parallel Scientific Advice’. British Journal of Clinical Pharmacology 82, no. 4 (2016): 965–973.
https://doi.org/10.1111/bcp.13023
Urbina, Irene, Roisin Adams, Judith Fernandez, Anne Willemsen, Niklas Hedberg, and Alric Rüther. ‘Advancing Cooperation in Health Technology Assessment in Europe: Insights from the EUnetHTA 21 Project amidst the Evolving Legal Landscape of European HTA’. International Journal of Technology Assessment in Health Care 40, no. 1 (January 2024): e75.
https://doi.org/10.1017/S0266462324004689
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
Wang, Ting, Neil McAuslane, Helga Gardarsdottir, Wim G. Goettsch, and Hubert G. M. Leufkens. ‘Building HTA Insights into the Drug Development Plan: Current Approaches to Seeking Early Scientific Advice from HTA Agencies’. Drug Discovery Today 27, no. 1 (1 January 2022): 347–353.
https://doi.org/10.1016/j.drudis.2021.09.014
Wang, Ting, Neil McAuslane, Wim G. Goettsch, Hubert G. M. Leufkens, and Marie L. De Bruin. ‘Regulatory, Health Technology Assessment and Company Interactions: The Current Landscape and Future Ecosystem for Drug Development, Review and Reimbursement’. International Journal of Technology Assessment in Health Care 39, no. 1 (January 2023): e20.
https://doi.org/10.1017/S0266462323000144
Wang, Ting, Neil McAuslane, Lawrence Liberti, Hubert Leufkens, and Anke Hövels. ‘Building Synergy between Regulatory and HTA Agencies beyond Processes and Procedures—Can We Effectively Align the Evidentiary Requirements? A Survey of Stakeholder Perceptions’. Value in Health 21, no. 6 (1 June 2018): 707–714.
https://doi.org/10.1016/j.jval.2017.11.003
Wested, Jakob. ‘The New Regulation of Health Technology Assessments Reports’. European Health & Pharmaceutical Law Review (EHPL) 6, no. 3 (2022): 122–126.
https://doi.org/10.21552/ehpl/2022/3/6
