A literature review was conducted with the expressions “Genetically modified organisms and ATMPs” and “Genetically modified organisms and investigational medicinal products”, in English and in French between the 14 and 29 January 2025, in the following databases: Dalloz, HeinOnline, Lexbase, Lexis 360, Lextenso, Navis, Le Doctrinal, Brill and 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.
Anliker, B., S. Longhurst, and C.J. Buchholz. ‘Environmental Risk Assessment for Medicinal Products Containing Genetically Modified Organisms’. Bundesgesundheitsblatt – Gesundheitsforschung – Gesundheitsschutz 53, no. 1 (1 January 2010): 52-57. https://doi.org/10.1007/s00103-009-0986-2.
Auby, Jean-Marie, and Georges Viala. ‘Médicaments humains et « organismes génétiquement modifiés » « OGM »’. Revue Droit Sanitaire et Social, no. 1 (15 March 1996): 38-39.
Bachtarzi, Houria, and Tim Farries. ‘The Genetically Modified Organism Medicinal Framework in Europe, United States, and Japan: Underlying Scientific Principles and Considerations Toward the Development of Gene Therapy and Genetically Modified Cell-Based Products’. Human Gene Therapy Clinical Development 30, no. 3 (September 2019): 114-128. https://doi.org/10.1089/humc.2019.042.
Baldo, Aline. ‘General Considerations on the Biosafety of Virus-Derived Vectors Used in Gene Therapy and Vaccination’. Current Gene Therapy, no. 13 (2013): 385-394
Baldo, Aline, Amaya Leunda, Nicolas Willemarck, and Katia Pauwels. ‘Environmental Risk Assessment of Recombinant Viral Vector Vaccines against SARS-Cov-2’. Vaccines 9, no. 5 (05/2021): 453. https://doi.org/10.3390/vaccines9050453.
Beattie, Stuart. ‘Call for More Effective Regulation of Clinical Trials with Advanced Therapy Medicinal Products Consisting of or Containing Genetically Modified Organisms in the European Union’. HUMAN GENE THERAPY 32, no. 19–20 (October 2021): 997-1003. https://doi.org/10.1089/hum.2021.058.
Bergé, Jean-Sylvestre. ‘Droit communautaire, biomédecine et biotechnologies : entre concordance et antinomie’. Revue trimestrielle de droit Européen (RTD. Eur.), no. 4 (16 December 2002): 627-652.
Black, Julia. ‘Regulation as Facilitation: Negotiating the Genetic Revolution Human Genetics and the Law: Regulating a Revolution’. Modern Law Review 61, no. 5 (1998): 621-660.
Bleijs, D. A., I. T. W. C. Haenen, and J. E. N. Bergmans. ‘Gene Therapy Legislation in The Netherlands’. The Journal of Gene Medicine 9, no. 10 (2007): 904-909. https://doi.org/10.1002/jgm.1095.
Brosset, Estelle. ‘Les « petites » histoires du droit de l’Union de la bioéthique : le cas de l’édition génomique’. Revue de l’Union européenne | Dalloz, no. 656 (4 March 2022): 158-166.
Buechner, Jochen, Marie José Kersten, Miriam Fuchs, Florence Salmon, and Ulrich Jäger. ‘Chimeric Antigen Receptor-T Cell Therapy’. HemaSphere 2, no. 1 (2 February 2018): e18. https://doi.org/10.1097/HS9.0000000000000018.
Cayla, Jean-Simon. ‘Utilisation thérapeutique et alimentaire des organismes génétiquement modifiés (OGM)’. Revue Droit Sanitaire et Social, no. 3 (15 September 2000): 516-519.
Celis, Patrick, Giada Farinelli, Ana Hidalgo-Simon, Pauline Meij, Mara Tihaya, Martina Schüssler-Lenz, and Marcos Timón. ‘EMA Commentary on the Guideline on Quality, Nonclinical and Clinical Aspects of Medicinal Products Containing Genetically Modified Cells’. British Journal of Clinical Pharmacology 90, no. 5 (2024): 1203–1212. https://doi.org/10.1111/bcp.16047.
Chevreau, Laura. ‘Protection de l’environnement et protection de la santé humaine, deux objectifs conflictuels aux temps de la pandémie de la Covid-19: focus sur les essais de médicaments à usage humain contenant des organismes génétiquement modifiés ou consistant en de tels organismes’. Journal de Droit de la Santé et de l’Assurance Maladie (JDSAM), no. 27 (1 December 2020): 104-109.
Corti, Nicoletta, Christopher Chiu, Rebecca J. Cox, Clarisse Demont, Jeanne-Marie Devaster, Othmar G. Engelhardt, Andrew Gorringe, et al.‘Regulatory Workshop on Challenge Strain Development and GMP Manufacture – A Stakeholder Meeting Report’. Biologicals 85 (1 February 2024): 101746. https://doi.org/10.1016/j.biologicals.2024.101746.
Cristol, Danièle. ‘Le régime des recherches biomédicales à l’aune du décret du 26 avril 2006’. Revue Droit Sanitaire et Social, no. 4 (10 July 2006): 672-685.
Cronin, Antonia, Rebecca Thom, Ekaterine Berishvili, Laura Mar Fonseca, Fanny Lebreton, Kevin Bellofatto, Juliette Bignard, et al. ‘Regulatory Challenges at the Intersection of Cellular and Medical Device Therapies in Europe: The Case of the Bioartificial Pancreas Symposium: Regulatory Futures and Medical Devices’. Law, Technology and Humans 5, no. 2 (2023): 114–133. https://doi.org/10.5204/lthj.3118.
Damerval, Margaux, Christine Fagnoni-Legat, Aurélien Louvrier, Sarah Fischer, Samuel Limat, Anne-Laure Clairet, Virginie Nerich, Isabelle Madelaine, and Marie Kroemer. ‘ATMP Environmental Exposure Assessment in European Healthcare Settings: A Systematic Review of the Literature’. Frontiers in Medicine 8 (1 December 2021). https://doi.org/10.3389/fmed.2021.713047.
Dederer, Hans-Georg, and David Hamburger. ‘Are Genome-Edited Micro-Organisms Covered by Directive 2009/41/EC? – Implications of the CJEU’s Judgment in the Case C-528/16 for the Contained Use of Genome-Edited Micro-Organisms’. Journal of Law and the Biosciences 9, no. 1 (2022): 1-27. https://doi.org/10.1093/jlb/sabO33
Dederer, Hans-Georg. ‘Comparative Analysis’. In Regulation of Genome Editing in Human IPS Cells, 289–329. Springer, Cham, 2022. https://doi.org/10.1007/978-3-030-93023-3_9.
‘Introductory Remarks’. In Regulation of Genome Editing in Human IPS Cells, 1–14. Springer, Cham, 2022. https://doi.org/10.1007/978-3-030-93023-3_1.
Fabri, Benjamin, Guillaume Sicard, Laurence Gauthier-Villano, and Bertrand Pourroy. ‘Circuit pharmaceutique du médicament de thérapie innovante (MTI) en France : état des lieux et perspectives’. Annales Pharmaceutiques Françaises, 17 April 2023. https://doi.org/10.1016/j.pharma.2023.04.001.
Faltus, Timo, and Iñigo de Miguel Beriain. ‘The EU Legal Framework on Clinical Trials Directed to Therapeutic Germline Gene Alteration: A Critical and Systematic Analysis’. Medical Law International 23, no. 1 (1 March 2023): 44-70. https://doi.org/10.1177/09685332231154586.
Favre, Didier, and Jean-François Viret. ‘Biosafety Evaluation of Recombinant Live Oral Bacterial Vaccines in the Context of European Regulation’. Vaccine, 3rd International Conference on Vaccines for Enteric Diseases, 24, no. 18 (1 May 2006): 3856-3864. https://doi.org/10.1016/j.vaccine.2005.07.018.
Fischer, Piret, Thomas Reiss, Jörg Mahlich, Erwan Gicquel, Heike Aichinger, Liliya Pullmann, and Tanja Bratan. ‘Unlocking the Value of Innovative Medicines: Insights from the Advanced Therapy Medicinal Products (ATMP) Innovation Systems in Germany and Sweden’. Health Policy and Technology 12, no. 2 (1 June 2023): 100744. https://doi.org/10.1016/j.hlpt.2023.100744.
Fleischmann, Tobias. ‘Assessing the Environmental Fate of RAAV in Activated Sludge and Water: Implications for Environmental Risk Assessments and GMO Regulatory Frameworks’. Journal of Environmental Management 345 (1 November 2023): 118754. https://doi.org/10.1016/j.jenvman.2023.118754.
Frech, Marion, Florian Dexel, Margareta Burgard, and Yvonne Seibel. ‘The national legislation accompanying the approval procedure for clinical trials of medicinal products for human use under Regulation (EU) No. 536/2014’. Die nationale Begleitgesetzgebung zum Genehmigungsverfahren klinischer Prüfungen mit Humanarzneimitteln im Rahmen der Verordnung (EU) Nr. 536/2014’. Bundesgesundheitsblatt – Gesundheitsforschung – Gesundheitsschutz 66, no. 1 (1 January 2023): 12-20. https://doi.org/10.1007/s00103-022-03629-5
Frenken, Gregor, and Hannah Lüttge. Regulation of Genome Editing in Human IPS Cells: Germany’. In Regulation of Genome Editing in Hu ‘man IPS Cells, 29–81. Springer, Cham, 2022. https://doi.org/10.1007/978-3-030-93023-3_3.
Frey, Joachim. ‘Biological Safety Concepts of Genetically Modified Live Bacterial Vaccines’. Vaccine, 4th International Veterinary Vaccines and Diagnostics Conference, Oslo, 25-29 June 2006, 25, no. 30 (26 July 2007): 5598-5605. https://doi.org/10.1016/j.vaccine.2006.11.058.
Galli, Maria Cristina, and Mercedes Serabian. Regulatory Aspects of Gene Therapy and Cell Therapy Products: A Global Perspective. Advances in Experimental Medicine and Biology, volume 871. Cham [Milwaukee, Wis.]: Springer American Society of Gene & Cell Therapy, 2015.
Garcia-Perez, Laura, Anita Ordas, Kirsten Canté-Barrett, Pauline Meij, Karin Pike-Overzet, Arjan Lankester, and Frank J. T. Staal. ‘Preclinical Development of Autologous Hematopoietic Stem Cell-Based Gene Therapy for Immune Deficiencies: A Journey from Mouse Cage to Bed Side’. Pharmaceutics 12, no. 6 (June 2020): 549. https://doi.org/10.3390/pharmaceutics12060549.
Ginn, Samantha L., Ian E. Alexander, Michael L. Edelstein, Mohammad R. Abedi, and Jo Wixon. ‘Gene Therapy Clinical Trials Worldwide to 2012 – an Update’. The Journal of Gene Medicine 15, no. 2 (2013): 65–77. https://doi.org/10.1002/jgm.2698.
Ham, Renske M. T. ten, Jarno Hoekman, Anke M. Hövels, Andre W. Broekmans, Hubert G. M. Leufkens, and Olaf H. Klungel. ‘Challenges in Advanced Therapy Medicinal Product Development: A Survey among Companies in Europe. Molecular Therapy – Methods & Clinical Development 11 (14/12/2018): 121–130. https://doi.org/10.1016/j.omtm.2018.10.003.
Hartmann, Jessica, Martina Schüßler‐Lenz, Attilio Bondanza, and Christian J Buchholz. ‘Clinical Development of CAR T Cells—Challenges and Opportunities in Translating Innovative Treatment Concepts’. EMBO Molecular Medicine 9, no. 9 (09/2017): 1183–1197. https://doi.org/10.15252/emmm.201607485.
Hidalgo-Simon, Ana, and Willem E. Fibbe. ‘Advanced Therapies Are Ready to Take Centre Stage: Academia’s Involvement with Regulation Needs to Raise Its Game’. British Journal of Clinical Pharmacology 87, no. 6 (2021): 2412–2413. https://doi.org/10.1111/bcp.14863.
Jose, Jobin, and Swathi Pai. ‘Comparison of Regulatory Framework of Clinical Trial with Genetically Modified Organism-Containing Vaccines in the Europe, Australia, and Switzerland’. Clinical and Experimental Vaccine Research 10, no. 2 (May 2021): 93-105. https://doi.org/10.7774/cevr.2021.10.2.93.
Kauffmann, Florence, Pierre Van Damme, Geert Leroux-Roels, Corinne Vandermeulen, Nele Berthels, Claire Beuneu, and Stéphanie Mali. ‘Clinical Trials with GMO-Containing Vaccines in Europe: Status and Regulatory Framework’. Vaccine 37, no. 42 (30 September 2019): 6144-6153. https://doi.org/10.1016/j.vaccine.2019.08.018.
Kennedy, Cormac, Edel O’Dea, Derval Reidy, Jeremy Towns, Maria Pigott, David Kevans, Declan O’Rourke, and Martina Hennessy. ‘Challenging Times: Delivering Gene Therapies and an Opportunity for Shared Learning’. British Journal of Clinical Pharmacology 88, no. 5 (2022): 2444-2446. https://doi.org/10.1111/bcp.15125.
Kenter, Marcel J. H., J. C. Clevers, Jan Cornelissen, and René H. Medema. ‘[Environmental regulations impede cancer research and treatment]’. Nederlands Tijdschrift Voor Geneeskunde 163 (5/12/2019): D4267.
Kenter, Marcel J.H. ‘Is It Time to Reform Oversight of Clinical Gene Therapy in the EU?’ British Journal of Clinical Pharmacology 85, no. 1 (2019): 8–10. https://doi.org/10.1111/bcp.13795.
Klein, Kevin, Pieter Stolk, Pär Tellner, Virginia Acha, Sarah Montagne, and Isabelle Stöckert. ‘Regulatory Flexibilities and Guidances for Addressing the Challenges of COVID-19 in the EU: What Can We Learn from Company Experiences?’Therapeutic Innovation & Regulatory Science 56, no. 2 (1/032022): 366–377. https://doi.org/10.1007/s43441-022-00383-3.
Koščík, Michal, and Eliška Vladíková. ‘The Object-Based and Process-Based Regulation of Genome Editing’. In Governing, Protecting, and Regulating the Future of Genome Editing, 160–79. Brill Nijhoff, 2023. https://doi.org/10.1163/9789004526136_009.
Križ, Nikolaus G. ‘Regulation of Immunologicals in the European Union: Current and Emerging Issues’. Biologicals, Special section (pp. 201-254): Marker vaccines and differential diagnostic tests in disease control and eradication), 33, no. 4 (1/12/2005): 247–252. https://doi.org/10.1016/j.biologicals.2005.08.008.
Kühler, Thomas C., Mikael Andersson, Gunnar Carlin, Ann Johnsson, and Lennart Åkerblom. ‘Do Biological Medicinal Products Pose a Risk to the Environment?’ Drug Safety 32, no. 11 (1 November 2009): 995-1000. https://doi.org/10.2165/11316540-000000000-00000.
‘Le cas particulier des médicaments de thérapie innovante préparés ponctuellement composés en tout ou partie d’OGM’. Wolters Kluwer France, 1/10/2020.
Leunda, Amaya, Aline Baldo, Martine Goossens, Kris Huygen, Philippe Herman, and Marta Romano. ‘Novel GMO-Based Vaccines against Tuberculosis: State of the Art and Biosafety Considerations’. Vaccines 2, no. 2 (June 2014): 463-499. https://doi.org/10.3390/vaccines2020463.
Lirsac, Pierre Noel, Olivier Blin, Jérémy Magalon, participants of round table N°5 of Giens XXX:, Pierre Angot, Estelle de Barbeyrac, Pascal Bilbault, et al. ‘Creating conditions for the success of the French industrial advanced therapy sector’. Therapie 70, no. 1 (2015): 69-94. https://doi.org/10.2515/therapie/2015005.
Mahalatchimy, Aurelie, Pin Lean Lau, Phoebe Li, and Mark L. Flear. ‘Framing and Legitimating EU Legal Regulation of Human Gene-Editing Technologies: Key Facets and Functions of an Imaginary’. Journal of Law and the Biosciences 8, no. 2 (2021): 1-30. https://doi.org/ 10.1093/jlb/lsaa080.
Mahalatchimy, Aurélie. ‘Regulation of Genome Editing in Human IPS Cells: France’. In Regulation of Genome Editing in Human IPS Cells, 83–106. Springer, Cham, 2022. https://doi.org/10.1007/978-3-030-93023-3_4.
Mahalatchimy, Aurélie, and Emmanuelle Rial-Sebbag. ‘Deciphering the Fragmentation of the Human Genome Editing Regulatory Landscape’. Frontiers in Political Science 3 (27/01/2022). https://doi.org/10.3389/fpos.2021.793134.
McGoldrick, Mic, Thierry Gastineau, Diane Wilkinson, Cristiana Campa, Norbert De Clercq, Andrea Mallia-Milanes, Olivier Germay, et al. ‘How to Accelerate the Supply of Vaccines to All Populations Worldwide? Part II: Initial Industry Lessons Learned and Detailed Technical Reflections Leveraging the COVID-19 Situation’. Vaccine 40, no. 9 (23 February 2022): 1223-1230. https://doi.org/10.1016/j.vaccine.2021.12.038.
Mizoguchi, Hirokuni, Tobias Fleischmann, Masato Komuro, Takahiro Hirai, Akiko Ikeda, Kojiro Saito, Tomohiro Watahiki, and Gentaro Tajima. ‘Comparative Analysis of GMO Regulatory Requirements for AAV Vectors in the EU and Japan Focusing on the Shedding Data and Containment Measures’. Expert Opinion on Biological Therapy 24, no. 6 (2/06/2024): 529–542. https://doi.org/10.1080/14712598.2024.2371042.
Mourby, Miranda, Jessica Bell, Michael Morrison, Alex Faulkner, Phoebe Li, Edison Bicudo, Andrew Webster, and Jane Kaye. ‘Biomodifying the “Natural”: From Adaptive Regulation to Adaptive Societal Governance’. Journal of Law and the Biosciences 9, no. 1 (2022): 1-28. https://doi.org/ 10.1093/jlb/lsac018.
Mourby, Miranda, and Michael Morrison. ‘Gene Therapy Regulation: Could in-Body Editing Fall through the Net?’ European Journal of Human Genetics 28, no. 7 (July 2020): 979-981. https://doi.org/10.1038/s41431-020-0607-y.
Myhr, Anne Ingeborg. ‘DNA Vaccines: Regulatory Considerations and Safety Aspects’. Current Issues in Molecular Biology 22, no. 1 (April 2017): 79-88. https://doi.org/10.21775/cimb.022.079.
Nakhod, Valeriya, Anton Krivenko, Tatiana Butkova, Kristina Malsagova, and Anna Kaysheva. ‘Advances in Molecular and Genetic Technologies and the Problems Related to Their Application in Personalized Medicine’. Journal of Personalized Medicine 14, no. 6 (06/2024): 555. https://doi.org/10.3390/jpm14060555.
Pagès, Jean-Christophe. ‘Application des technologies de modifications ciblées au génome Humain, pour une évaluation des risques à la mesure de la variabilité des génomes’. Revue Juridique Personnes et Famille, no. 7–8 (1/07/2019): 1-9.
Peigné, Jérôme. ‘Le nouveau statut des produits de thérapies génique et cellulaire’, no. 2 (14 March 2005): 220-231.
Pereira, Andre Dias. ‘Gene Editing: A Challenge for Homo Sapiens Genetics and Gene Manipulation’. Medicine and Law 36, no. 4 (2017): 5–28.
Pignard, J., L. Bernard, P. Chennell, and V. Sautou. ‘Gestion pharmaceutique des études cliniques de thérapie génique en France’. Le Pharmacien Hospitalier et Clinicien 50, no. 4 (1 December 2015): 434-443. https://doi.org/10.1016/j.phclin.2015.03.004.
Plas, Johan L. van der, Meta Roestenberg, Adam F. Cohen, and Ingrid M.C. Kamerling. ‘How to Expedite Early-Phase SARS-CoV-2 Vaccine Trials in Pandemic Setting—A Practical Perspective’. British Journal of Clinical Pharmacology 87, no. 5 (2021): 2167–2169. https://doi.org/10.1111/bcp.14435.
‘Policy Statement on the Social, Ethical and Public Awareness Issues in Gene Therapy’. The Journal of Gene Medicine 4, no. 6 (2002): 687–691. https://doi.org/10.1002/jgm.351.
Renner, Matthias, Brigitte Anliker, Ralf Sanzenbacher, and Silke Schuele. ‘Regulation of Clinical Trials with Advanced Therapy Medicinal Products in Germany’. In Regulatory Aspects of Gene Therapy and Cell Therapy Products: A Global Perspective, edited by Maria Cristina Galli and Mercedes Serabian, 87–101. Cham: Springer International Publishing, 2015. https://doi.org/10.1007/978-3-319-18618-4_5.
S s, Kirthiga Devi, Ramesh Joga, Saurabh Srivastava, Kalpana Nagpal, Isha Dhamija, Parul Grover, and Sandeep Kumar. ‘Regulatory Landscape and Challenges in CAR-T Cell Therapy Development in the US, EU, Japan, and India’. European Journal of Pharmaceutics and Biopharmaceutics 201 (1/08/2024): 114361. https://doi.org/10.1016/j.ejpb.2024.114361.
Sakurai, Akira, Seiichi Kanzaki, and Futaba Honda. ‘Japanese Pharmaceutical Regulations of Engineered Viral Vectors for Medical Use Compared With Those in the United States and the European Union’. Clinical Pharmacology & Therapeutics 113, no. 5 (2023): 960–962. https://doi.org/10.1002/cpt.2788.
Schagen, Frederik H. E., Rob C. Hoeben, and Geke A. P. Hospers. ‘Off-Label Prescription of Genetically Modified Organism Medicines in Europe: Emerging Conflicts of Interest?’ Human Gene Therapy 25, no. 10 (October 2014): 893-896. https://doi.org/10.1089/hum.2014.090.
Schalk, Johanna A.C., Frits R. Mooi, Guy A.M. Berbers, Leon A.G.J.M. van Aerts, Hans Ovelgönne, and Tjeerd G. Kimman. ‘Preclinical and Clinical Safety Studies on DNA Vaccines’. Human Vaccines 2, no. 2 (3 March 2006): 45-53. https://doi.org/10.4161/hv.2.2.2620.
Scheppler, Lorenz, Norbert De Clercq, Mic McGoldrick, and Jacqueline Dias. ‘Regulatory Harmonization and Streamlining of Clinical Trial Applications Globally Should Lead to Faster Clinical Development and Earlier Access to Life-Saving Vaccines’. Vaccine 39, no. 5 (29 January 2021): 790-796. https://doi.org/10.1016/j.vaccine.2020.11.077.
Schuurman, Henk-Jan, and Karin Hoogendoorn. ‘Solid Organ Xenotransplantation at the Interface between Research and Clinical Development: Regulatory Aspects’. Xenotransplantation 27, no. 3 (2020): e12608. https://doi.org/10.1111/xen.12608.
Schweizer, Rainer J., Hans Peter Bernhard, and Antonia S. Straden. ‘Regulation of Genome Editing in Human IPS Cells: Switzerland’. In Regulation of Genome Editing in Human IPS Cells, 107–198. Springer, Cham, 2022. https://doi.org/10.1007/978-3-030-93023-3_5.
Sheets, Rebecca. ‘Chapter 13 – Institutional Biosafety Committees and Regulation of Genetically Modified Organisms’. In Fundamentals of Biologicals Regulation, edited by Rebecca Sheets, 209-218. Academic Press, 2018. https://doi.org/10.1016/B978-0-12-809290-3.00013-4.
Spink, J, and D Geddes. ‘Gene Therapy Progress and Prospects: Bringing Gene Therapy into Medical Practice: The Evolution of International Ethics and the Regulatory Environment’. Gene Therapy, (22/09/2004), 1611–1616. https://doi.org/:10.1038/ sj.gt.3302354.
Tajima, Gentaro, Seoan Huh, Natalie Anne Schmidt, Judith C. Macdonald, Tobias Fleischmann, and Keith Merrell Wonnacott. ‘Impact of Genetically Modified Organism Requirements on Gene Therapy Development in the EU, Japan, and the US’. Molecular Therapy – Methods & Clinical Development 26 (8 September 2022): 74-83. https://doi.org/10.1016/j.omtm.2022.05.012
Trouvin, Jean-Hugues. ‘[Sanitary safety of GMOs used in therapeutics]’. Bulletin De l’Academie Nationale De Medecine 186, no. 8 (2002): 1401-1409.
Trouvin, J.-H. ‘[Health security-GMOs in therapeutics]’. Annales Pharmaceutiques Francaises 61, no. 2 (March 2003): 103-108.
Tzifa, Georgia, and Lukas Simas. ‘Gene Editing Techniques Are Subject to GMO Regulatory Framework in C-528/16 Confederation Paysanne and Others Case Notes’. European Pharmaceutical Law Review (EPLR) 2, no. 4 (2018): 210-214.
Vàzquez-Salat, Núria, and Louis-Marie Houdebine. ‘Will GM Animals Follow the GM Plant Fate?’ Transgenic Research 22, no. 1 (1 February 2013): 5-13. https://doi.org/10.1007/s11248-012-9648-5.
Verheust, Céline, Martine Goossens, Katia Pauwels, and Didier Breyer. ‘Biosafety Aspects of Modified Vaccinia Virus Ankara (MVA)-Based Vectors Used for Gene Therapy or Vaccination’. Vaccine 30, no. 16 (30 March 2012): 2623–32. https://doi.org/10.1016/j.vaccine.2012.02.016.
Whomsley, Rhys, Victoria Palmi Reig, and Ana Hidalgo-Simon. ‘Environmental Risk Assessment of Advanced Therapies Containing Genetically Modified Organisms in the EU’. British Journal of Clinical Pharmacology 87, no. 6 (2021): 2450-2458. https://doi.org/10.1111/bcp.14781.