The Coordination Unit of the Andalusian Network for the design and translation of Advanced Therapies fosters progress in the field of advanced therapies by supporting all phases related to the development of these medicinal products. The pre-clinical or non-clinical (regulatory term) research is one such phase which precedes the design of a clinical trial in humans.
Pre-clinical research is of extreme importance to guarantee the safety and efficacy of medicinal products in research which must be later demonstrated through clinical research in human beings.
The work model presented in this area of preclinical research impacts upon the adherence of a therapeutic candidate to the most stringent regulatory requirements from the corresponding agencies (AEMPS and EMA) before entering the clinical research phase. Consequently, the Coordination Unit supports preclinical research groups in submitting queries to regulatory agencies (scientific advice), preparation of documents, designing regulatory studies and getting funding through competitive calls.
Due to the need of complying with the principles of Good Laboratory Practice in safety studies, the Coordination Unit of the ANd&tAT are working to facilitate the design and implementation of these studies in the research centres of our region. Likewise, given that it is essential, with regards to translation, that the preclinical studies are carried out with the product manufactured in clinical (or GMP-like) grade conditions to avoid changes in the identity and potency of the medicinal product in research, the Coordination Unit works in close collaboration with the GMP laboratories Network of the Andalusian Public Health System.
