CURRENT REGULATIONS FOR MARKETING AUTHORIZATION OF HUMAN GENERIC PRODUCTS GLOBALLY AS PER WHO
Journal Title: Asian J of Pharm Sci & Tech - Year 2014, Vol 4, Issue 4
Abstract
ABSTRACT Generic medicines are those where patent protection has expired, and which may be produced by manufacturers other than the innovator company. Use of generic medicines has been increasing in recent years, primarily as a cost saving measure in healthcare provision. Generic medicines are typically 20 to 90% cheaper than originator equivalents. As the Pharmaceutical industry is expanding by leaps and bound no single country is capable of manufacturing all the drugs in required quantities at competing prices. Hence the Marketing Authorizations has become an essential part of Global Healthcare. Till sometime back Marketing Authorization procedures were country specific. However currently it has been harmonized. In spite of this there are regional variations that make the authorizations very complex to comply with. The present study describes a brief review of Marketing Authorizations in various countries and regions around the world (WHO). Key words: Generic, Medicine, Drug, Pharmaceutical, Biosimilar, Prescribing, Healthcare, Economics, WHO.
Authors and Affiliations
Vamseedhar Naik Bukke* , Lokesh Reddy M, Alagu Sundaram M, Umasankar K, Jayachandra Reddy P
Keywords
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