Global regulatory perspective of bulk pharmaceutical excipients

G.L. Pramod, K.S. Reddy, J.D. Reddy, S.G. Vasantharaju

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Regulations for pharmaceutical bulk excipients are stringent as same as pharmaceutical medicines. In case of new excipient, applicant has to submit safety & quality data. In case of approved or existed excipient applicant has to submit literature reference data i. e. FDA inactive ingredients guide, the national formulary, U.K. ABPI data sheets as part of the drug submissions. In U.S, FDA assesses & permits use of excipients as part of a new drug application (NDA). In E.U, it is assumed that novel excipients need to be evaluated as new chemical entities. In Japan, separate evaluation process is there for novel excipients. The main drawback of development of excipients is lack of specific regulatory (national & international) guidelines. The lack of international regulatory guidelines lead to the formation of the international pharmaceutical excipients council (IPEC) in 1991.It has championed the international standardization of excipients, the introduction of useful new excipients, and the development of safety evaluation guidelines. These guidelines, addressing all the primary routes of drug administration, have been published. Due to the harmonization of standards of the excipients among the member states, rapid development occurred in pharmaceutical excipient industry.
Original languageEnglish
JournalPharmaceutical Reviews
Issue number3
Publication statusPublished - 2010


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