Comprehensive review and enhancing approaches for Pediatric investigation plan in USA, EU and India
Abstract
Several various regulations connected to paediatric clinical investigations characterise the regulatory framework in the United States, EU and INDIA. Regulations that govern the requirements for conducting paediatric studies or provide incentives for sponsors to perform such studies have been implemented in these countries. The Food and Drug Administration in the United States has a comprehensive set of paediatric rules. It has established a distinct department for paediatric medication regulations, known as the Pediatric Therapeutics Offices. The FDA Modernization Statute was passed in the United States of America as the first act for paediatric population clinical trials (1997). These laws govern the incentives for drug developers to do paediatric research (after receiving a written request from the FDA) as well as the standards for conducting paediatric clinical trials. In Europe, the 'Pediatric Regulation (EC) No 1901/2006' was adopted in January 2007 to improve the protection of children in research, while India has no special standards for pediatric investigation. In order to promote better medicines for children, regulatory bodies in the United States and Europe have done a terrific job. There is presently no specific rule for paediatric clinical trials in India, however some provisions are included in Schedule Y. For the safety of children, the Indian health authorities must enact separate legislation for clinical trials. Enhancing approaches are needed for all conceivable indications will be assessed based on the product's mechanism of action, data from other development programmes, proof of concept studies, and so on. Pediatric experts will be consulted to examine each indication.
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