A REGULATORY CONSIDERATIONS FOR PHARMACEUTICAL EXCIPIENTS IN THE EUROPEAN UNION
Tejaswi Jalindar Aher*, Dr. Kishor S. Salunkhe and Pooja Janardan Pagar
ABSTRACT
The main aim of this study is to understand the regulatory overview on the excipients in the European Union. Excipients were considered as pharmacologically inactive ingredient but excipients are not inactive, they are main partners in the formulation and number of excipients in a formulation is greater than that of API. Hence, they have an impact on the manufacture, quality, safety and efficacy of an API. In many countries tragedies have taken place in past and draw attention of regulators towards the quality of excipients. There is a strong need of regulations and evaluation for excipients so as to avoid the unnecessary
adverse effects and interaction with the API, other excipients, container.
Keywords: Excipients, Novel excipients, Dossier, CTD, CEP.
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