Clinical trials of advanced therapy investigational medicinal products in Spain: preparing for the European clinical trials regulation

Published: 8 November 2019
Regulatory Insight
Juan Estevez Alamo,
Juan Estevez Alamo
at Agencia Espanola de Medicamentos y Productos Sanitarios
Marcos Timón,
Marcos Timón
Cristina González Gómez-Platero,
Cristina González Gómez-Platero
Carmen Doadrio Abad,
Carmen Doadrio Abad
at Agencia Espanola de Medicamentos y Productos Sanitarios
Marta Velasco Gonzalez,
Marta Velasco Gonzalez
at Agencia Espanola de Medicamentos y Productos Sanitarios
Maria Angeles Martin de la Sierra San Agustin
Maria Angeles Martin de la Sierra San Agustin
at Agencia Espanola de Medicamentos y Productos Sanitarios

Clinical trials (CT) of Advanced Therapy Medicinal Products are a reality worldwide. Although ATMPs are still very innovative therapies, it is interesting to investigate what relevant information can be obtained from the analyses of authorized CT and the investigated products. The aim of this study was to follow the evolution of CT with Advanced Therapy investigational Medicinal Products (ATiMP) authorized in Spain from May 2004 to June 2019 on the basis of information available at the Spanish Agency for Medicinal Products and Medical Devices and their real status (also taking into consideration their status in three different official Registries). We will also discuss how sponsors and Authorities can prepare for the coming new clinical trial regulation and take advantage of the opportunities it may present.

Read now