CLINICAL RESEARCH AND DRUG REGULATION IN THE CHALLENGING TIMES OF INDIVIDUALIZED THERAPIES: A PIVOTAL ROLE OF CLINICAL PHARMACOLOGY

Since the 1980s, medical specialists in Clinical Pharmacology have been playing a crucial role in the development of drug regulation in Spain. In this article we report on the activities carried out and the prospects for development in three very relevant areas from the regulatory perspective: 1) th...

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Bibliographic Details
Published in:Pharmacological research 2024-01, Vol.199, p.107045-107045, Article 107045
Main Authors: Gómez-Outes, Antonio, Sancho-López, Aránzazu, Carcas Sansuan, Antonio J, Avendaño-Solá, Cristina
Format: Article
Language:English
Subjects:
Academic clinical trials
Access to non-approved medicines
Advanced therapies
Hospital exemption
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Summary:Since the 1980s, medical specialists in Clinical Pharmacology have been playing a crucial role in the development of drug regulation in Spain. In this article we report on the activities carried out and the prospects for development in three very relevant areas from the regulatory perspective: 1) the development of stable public infrastructures to facilitate non-commercial clinical research with medicines, 2) the regulatory aspects of individual access to medicines in special situations, beyond their regular access after marketing approval and funding by the National Health System, and 3) the challenges of development and access to advanced therapies, with special reference to the figure of the hospital exemption.
ISSN:1043-6618
1096-1186
DOI:10.1016/j.phrs.2023.107045