REGULATORY APPROVAL OF GENERICS IN CANADA MARKET
Journal Title: Int J of Pharm Rev& Res - Year 2015, Vol 5, Issue 3
Abstract
The present thesis determines the regulations and regulatory approval process of generics in Canada. Canada is the largest individual market in North America. It is the 8th largest market in the world and in the pharmaceutical sales the Canada country is containing 2.5 percentage of sales in global market. In the 2009-2013 recent survey Canada is the 7th fastest growing country in the north America most of the company undertaking research and development (R&D) and to develop the new or improved patent therapies and other developing taking on other bio-equivalent and subsequent entries of biologics and generics it will taking a shape. Most of the brand name products will be account for 76 percentage in Canada country and 37 percentage of prescriptions and rest of the account in generics. In the activity of research and development the pharmaceutical companies on Canada can expenditure $ 1 billion since 2011 then from 2001-2012 fallen by 15.6 percentage. Then for regulatory requirements for registration of generics can be authorized by national association of pharmacy regulatory authorities (NAPRA) and then prescription drugs are evaluated by Canadian generic pharmaceutical association (CGPA), Health Products and Food Branch Inspectorate (HPFBI) . There are different requirements for registration or approval of product in Canada for the regulatory agencies requires the pharmaceutical dossier to get an approval to the market drugs. The dossier document can represents the technical aspects of a particular drug formats is explain elaborately at a certain manner as like about the administrative information, chemical manufacturing control, non-clinical reports, and clinical reports, approval forms attached at certain manner. The pharmaceutical companies are prepare dossier at certain formats like common technical document (CTD) / electronic technical document (ECTD) / NON-CTD (country on specific guidelines). Some of the CIS countries like fallow their own dossier formats
Authors and Affiliations
Theja R, Sreekanth Reddy CP , Alagusundaram M, , P Jayachandra Reddy
Keywords
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