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The European Regulation 536/2014, entered into force on June 16, 2014 and not effective for several years for a delay in the development of a fully functional European portal, has represented a turning point in the legislation regarding clinical trials on medicinal products. Unlike other countries, Italy was unable to translate the multitude of decrees regulating clinical trials in one legislative act.
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Cagnazzo et al. (2022) studied this question.
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