Unlike Unites States, the European Union considers botanicals as medicinal products with some similarity with pharmaceutical drugs. Therefore, EU follows stricter guidelines with respect to requirements for safety, plausible efficacy and quality data prior to approval of botanicals. In this editorial opinion paper, we have summarized various steps required for clinical approval of botanicals for marketing in EU.
Petrini, O., Prasad, C., Cicero, A. (2017). CLINICAL STUDIES WITH BOTANICALS AND HOW TO CARRY THEM OUT: THE EUROPEAN UNION PERSPECTIVE. CURRENT TOPICS IN NUTRACEUTICALS RESEARCH, 15(2), 57-62.
CLINICAL STUDIES WITH BOTANICALS AND HOW TO CARRY THEM OUT: THE EUROPEAN UNION PERSPECTIVE
Cicero, AFGUltimo
Supervision
2017
Abstract
Unlike Unites States, the European Union considers botanicals as medicinal products with some similarity with pharmaceutical drugs. Therefore, EU follows stricter guidelines with respect to requirements for safety, plausible efficacy and quality data prior to approval of botanicals. In this editorial opinion paper, we have summarized various steps required for clinical approval of botanicals for marketing in EU.File in questo prodotto:
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