Post Approval Life Cycle Management of Variations for Generic Drugs in Brazil

Abstract

Changes or variations in respect of any information concerning the registered or approved drug products, including information on the formulation of the registered/listed goods or other aspects of their manufacture, and the labeling of the goods, shall forthwith be notified to the agency and the change or variation shall not be implemented until approved by the agency. Changes occurs to have business continuity, if any quality problem arises, to maintain the economy, process improvisation, alternate addition of sources or exclusions. The applicants of registered generics who intend to make post-approval changes should follow the guidance or regulation in accordance to the ANVISA. Most of the regulations classify the changes for drug substances and drug products. The objective of this paper is to give insight and better understanding of the classification of changes in Brazil.

 Keywords: change, variation, Generics, ANVISA

Cite this Article

Jain A, Ganesh N. Post Approval Life Cycle Management of Variations for Generic Drugs in Brazil. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2017; 4(3): 37–42p.