Abbreviated new drug submission approval process: An overview

Abstract

A generic drug is a copy of a brand name drug which can be introduced into the market once innovators patent expires. More than 73% of prescription drugs sold at retail in Canada are generics and thus Canada represents the world’s 9th biggest market for generic drugs in terms of value. Canada’s generic pharmaceutical sector produces domestically less than 10% of the active pharmaceutical ingredients used in its medicines. It also imports 88% of the finished dose products. Drug manufacturer has to demonstrate that its product is pharmacologically effective and bioequivalent to the innovator’s drug. The generic drug is bioequivalent or pharmaceutically equivalent to the Canadian Reference Product (CRP). The Abbreviated New Drug submission (ANDS) regulations were created to make the generic drug approval process simpler and more cost-effective by health drug Canada.