Global regulatory perspective of bulk pharmaceutical excipients

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

Research output: Contribution to journalArticle

Abstract

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
Volume8
Issue number3
Publication statusPublished - 2010

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Excipients
Pharmaceutical Preparations
Guidelines
Drug Administration Routes
Safety
Pharmacopoeias
Drug Industry
Licensure
Japan

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Pramod, G.L. ; Reddy, K.S. ; Reddy, J.D. ; Vasantharaju, S.G. / Global regulatory perspective of bulk pharmaceutical excipients. In: Pharmaceutical Reviews. 2010 ; Vol. 8, No. 3.
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note = "Export Date: 10 November 2017 Correspondence Address: Pramod, G. L.; Faculty, Dept of Pharamaceutical Quality assurance, Manipal College of Pharmaceutical Sciences, MANIPAL-576 104, India References: Ashok, K., Chabul, V.M., Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems FDA Perspective On Regulation of Pharmaceutical Excipients, pp. 37-50. , New York (USA). Informa Health Care USA.2006, P.no 3-14. Regulation of Pharmaceutical Excipients, P.no; James, S., Encyclopedia of Pharmaceutical Technology (2007) Informa Health Care, 3, pp. 1656-1662. , Third Edition. New York (USA), Excipients: Safety Testing, Pharmaceutical Excipient Testing: Regulatory & Preclinical Perspective; Steinberg, M., Borzelleca, J.F., Enters, E.K., Kinoshita, F.K., Loper, A., Mitchell, D.B., Tamulinas, C.B., Weiner, M.L., A new approach to the safety assessment of pharmaceutical Excipients (1996) Regul.Toxicol. Pharm, 24, pp. 149-154; (2005) Nonclinical Studies For Development of Pharmaceutical Excipients, , www.fda.gov/cder/guidance, Center for Drug Evaluation and Research (CDER). Guidance for Industry, Final guidance issued by FDA CDER, May; (1996) Division of Drug Information Resources, , Inactive Ingredients Guide; U.S. Food and Drug Administration, Rockville, MD; ICH Guideline S7A: Safety Pharmacology Studies for Human Pharmaceuticals, Add citation for ICH S7 guidance; Department of Health and Human Services Food and Drug Administration, , http://www.cfsan.fda.gov/~rdb/opa-gras.html, FDA Inventory of GRAS Notifications, August 2004, available from; The proposed guidelines for the safety of new excipients (1997) Eur. Pharm. Rev, , The IPEC Europe Safety Committee, November; (1997), pp. 1299-1300. , European Pharmacopoeia, 3rd Ed.; European Pharmacopoeia Commission, Council of Europe: Strasbourg, France; (1995), United States Pharmacopeia, 23rd Ed.; United States Pharmacopeial Convention, Inc.: Rockville, MD; (1996) The Society of Japanese Pharmacopoeia, , Japanese Pharmacopoeia, 13th Ed, Yakuji Nippo Ltd.: Tokyo; Uchiyama, M., Regulatory status of excipients in Japan (1999) Drug Inform. J, 33, pp. 27-32",
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Global regulatory perspective of bulk pharmaceutical excipients. / Pramod, G.L.; Reddy, K.S.; Reddy, J.D.; Vasantharaju, S.G.

In: Pharmaceutical Reviews, Vol. 8, No. 3, 2010.

Research output: Contribution to journalArticle

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