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Preclinical regulatory approach before clinical development and marketing authorization of medicinal products in the European Union

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Autors: Caballero-Garrido·E1#@, Martin Blanco NM1#, Gracia Moneva B1& 1Spanish Agency for Medicinal Products and Medical Devices (AEMPS). #These authors contribute equally. &Senior government official-Head of Non-clinical Evaluation Area. @ Corresponding author: ecaballero@aemps.es

Abstract: The non-clinical assessment first marketing approval of a pharmaceutical in the European Union mainly includes several recommendations developed in the International Council for Harmonisation (ICH) and European Medicines Agencies (EMA) guidelines. The recommendations in ICH guidelines further harmonize the non-clinical studies among the regions of the European Union (EU), Japan and the United States. These guidelines represent the consensus reached regarding the type and duration of non-clinical studies to support human clinical trials and marketing authorization for pharmaceutical products. More specifically, in the EU, the rationale and requirements for non-clinical testing in the development of medicinal products for human use are defined in Directive 2001/83/EC as amended. UE directive and EMA guidelines should be read in conjunction with ICH guidelines before applying for a clinical trial or marketing authorization in the EU. The Directive 2010/63/EU also should be considered to perform non-clinical studies taking into account the protection and welfare of animals used for scientific purposes. The main goals of the nonclinical studies generally include a characterization of pharmacology, pharmacokinetics, toxic effects concerning target organs, dose dependence, relationship to exposure, and, when appropriate, potential reversibility. These data should help to define the estimated therapeutic dose, the maximum dose, and dose steps and intervals for clinical trials in humans. The non-clinical studies recommended to support marketing authorization are conducted all along the process; hence, the requirements that must be satisfied are different for each phase. The guideline ICH M3 (R2) delivers practical recommendations for timing or when to conduct which non-clinical studies. Specific consideration should be taken into account for anticancer drugs and biotechnology-derived pharmaceuticals. We have summarized the main non-clinical studies required before clinical development and marketing authorization in the European Union.

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