Comparative study on regulatory requirements and filing procedure for DMF submission in US, Brazil and China

ABSTRACTThe top 10 fastest expanding pharmaceutical markets are the US, China, and Brazil. About 45% of the world'spharmaceutical market and 22% of its production are accounted by the US. There is still space to raise the share ofmedical and health expenditure. The ageing population, urbanisation, rising health awareness, and rising prevalenceof chronic diseases have all contributed to the sustained expansion of pharmaceutical demand. The generics sector inBrazil is the largest in Latin America and ranks sixth globally. The output of pharmaceutical value added is anticipatedto level off in 2022 but to increase by 4.5% in 2023. Every study's methodology follows a few recurring themes andspecific trajectories in order to achieve its goal. The method starts with the regulatory perspective's scope and purposeof the DMF filing requirements for the USA, China, and Brazil. The function of regulatory bodies and organizationsis crucial in ensuring that a nation's drug development process complies with all legal criteria. These regulatoryorganizations and agencies face numerous issues, including guaranteeing the efficacy, safety, and quality ofpharmaceuticals and medical devices, harmonizing the legislative processes governing drug development, monitoringand ensuring statutory compliance.