“Regulatory Sandboxes” Could Solve the Regulatory Problems Encountered in Europe and Arising from Innovation in Biological Medicinal Products
Author:
Funder
Labex Lipstic
Region Bourgogne - Franche Comté and the FEDER.
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Pharmacology
Link
https://link.springer.com/content/pdf/10.1007/s40290-023-00507-6.pdf
Reference19 articles.
1. European Union. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code Relating to Medicinal Products for Human Use. 2001.
2. Guerriaud M. Les médicaments de thérapie innovante: statut juridique In: LexisNexis, editor. JurisClasseur Droit Pharmaceutique; 2022.
3. Higel F, Seidl A, Sörgel F, Friess W. N-glycosylation heterogeneity and the influence on structure, function and pharmacokinetics of monoclonal antibodies and Fc fusion proteins. Eur J Pharm Biopharm. 2016;100:94–100. https://doi.org/10.1016/j.ejpb.2016.01.005.
4. Conseil d’État. 1ère 6ème SSR, 17/02/2012 No 332509. 2012.
5. Guerriaud M, Kohli E. RNA-based drugs and regulation: toward a necessary evolution of the definitions issued from the European union legislation. Front Med. 2022;9:1012497. https://doi.org/10.3389/fmed.2022.1012497.
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