Key Challenges and Impact Analysis of ICH Q12 in USA, Mexico and Brazil

Abstract

Post-approval changes are necessary throughout the life of a drug product to implement new knowledge, maintain state of control, and drive continual improvement. Many post-approval changes require regulatory agency approval by individual countries before implementation. Because of the global regulatory complexity, individual post-approval changes usually take years for full worldwide approval even when they reduce patient risk, improve compliance, and improve the manufacturing process and test methods. This study gives a Regulatory overview on post approval changes in various countries like USA, Mexico and Brazil. These countries have their individual regulatory agencies like USFDA for USA, COFEPRIS for Mexico and ANVISA for Brazil. They are responsible for ensuring all human and animal drugs, medical device, food and cosmetic products, tobacco and radiation emitting device. According to these guidelines post approval changes in USA and Mexico are classified in three categories Major Changes, Minor Changes and Moderate Changes. In Brazil, implementation can be procced after ANVISA’s approval. The discussion of this study would bring to light the on challenges and impact of ICH Q12 in USA, Mexico and Brazil. The primary objective of the ICH Q12 initiative through this guideline is to synchronize the system of post-approval globally, which can effectively diminish the expenses and time constraints for both regulatory authorities and the industry.