Abstract

A COMPARITIVE STUDY OF DMF (USFDA) AND EDMF (EU) AND IN BETWEEN PARA IV FILINGS (USFDA) AND IPR (EU)

Nimmala Vineela*, M. Beena Devi and M. V. Nagabhushanam

ABSTRACT

Pharmaceutical manufactures need to prepare a document and submitted solely at its discretion to the appropriate regulatory authority in the intended drug market. The file is known as the DMF in US and EDMF in EU the work into compare the drug master files between USFDA and EU for drug registration process and also vision to gain the research about Para IV filling in US and IPR in EU which is useful for the knowledge on drug patents. The literature work, the comparison parameters, difference in filing process of DMF and EDMF requirements has been studied and explained in detailed in this work, which gives the clear over view of the role of filing the DMF and EDMF. It also gives an outline work of PARA IV filings and IPR Studies.

Keywords: DMF, EDMF, PARA IV filings, IPR Studies and regulatory authority.