Abstract
Pharmaceutical innovation can sometimes clash with existing regulations, creating challenges for pioneering medicinal products, especially biologics, as they transition from the research phase to product development and post-approval categorisation. For instance, vaccines and advanced therapy medicinal products must fall under the category of biological medicinal products. However, the ability to chemically synthesise both proteins or mRNA can rule out classifying them as vaccines or advanced therapy medicinal products. Consequently, many organic products face regulatory obstacles when attempting to reach the market owing to their inherent natures or involved technologies. The European Commission’s proposal for a directive to overhaul the European Union pharmaceutical legislation brings in a new tool: the regulatory sandboxes. They could be a suitable solution to manufacture pioneering medicinal products. Regulatory sandboxes are a form of legal experimentation helping with the marketing of a medicinal product based on groundbreaking technology as they sidestep current regulations. In essence, a regulatory sandbox is a tailor-made, inherently flexible, and time-limited regulatory framework facilitating the development of a drug outside the standard regulatory framework.
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The Laboratoire d’Excellence Labex LipSTIC, ANR-11-LABX-0021, the Région Bourgogne Franche-Comté, and the ERDF (European Regional Development Fund) Committee have provided financial support for the preparation of this article.
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Mathieu Guerriaud has no conflicts of interest that are directly relevant to the content of this article.
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Guerriaud, M. “Regulatory Sandboxes” Could Solve the Regulatory Problems Encountered in Europe and Arising from Innovation in Biological Medicinal Products. Pharm Med 38, 19–23 (2024). https://doi.org/10.1007/s40290-023-00507-6
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DOI: https://doi.org/10.1007/s40290-023-00507-6