Process for review of an application submitted to EMA: A brief review

Abstract

Present scenario of regulatory world has been divided into two categories i.e., regulated countries and non - regulated countries. All the countries have their own rules and regulation. Here the regulatory bodies work like a bridge between market requirement and manufacturing unit. They ensure the safety and efficacy of the drug product which are available in the market. Once the drug molecule is discovered, non-clinical study of the drug should be conducted to ensure safety and efficacy. The clinical trials areconducted, after an application is submitted to competent authority. When theclinical trials are completed successfully as per approved protocols, the sponsor may apply for marketing authorization and the approval is given after reviewing the application. Even after approval, government monitors safety by post marketing surveillance. This review article describes the process involved in approval of drug to be marketed in European Union (EU) and also the roles of different committees in the approval process.