“Regulatory Sandboxes” Could Solve the Regulatory Problems Encountered in Europe and Arising from Innovation in Biological Medicinal Products-Reference-Cited by-同舟云学术

“Regulatory Sandboxes” Could Solve the Regulatory Problems Encountered in Europe and Arising from Innovation in Biological Medicinal Products

Published:2023-12-09 Issue:1 Volume:38 Page:19-23
ISSN:1178-2595
Container-title:Pharmaceutical Medicine
language:en
Short-container-title:Pharm Med

Author:

Guerriaud Mathieu^ORCID

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.

Cited by 1 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Revision of pharmaceutical legislation in the context of antimicrobial resistance and challenges facing the introduction of innovative antimicrobial medical products in Europe;Pharmacia;2024-05-13