Comparative Analysis of Regulatory Framework for Paediatric and Geriatrics Across The USA, EU and India

Abstract

Understanding the unique pharmacokinetic and pharmacodynamics characteristics of children and the elderly is crucial for tailoring drug effects. Consequently, it's imperative to validate drug efficacy in both demographics. This study delves into dosage and formulation research aligned with national guidelines in the US, EU, and India, focusing on regulatory frameworks for paediatric and geriatric medications. Plans for paediatric clinical studies, incentives, timelines, difficulties, and potential recommendations are covered. The Paediatric Research Equity Act (PREA) of the US Food and Drug Administration (FDA) requires, unless it is waived or postponed, that certain new drug and biologic applications contain a paediatric evaluation. Also Sponsors are encouraged to perform paediatric trials by the Best Pharmaceuticals for Children Act (BPCA), which offers possible 6-month marketing exclusivity or "paediatric exclusivity." Before the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E7 guideline was adopted in 1994, the FDA published a guideline in 1989 for the investigation of drugs anticipated to be used in the elderly (FDA, 1989). The three basic foundations of EU paediatric regulation are the Paediatric Committee (PDCO), the Paediatric Use Marketing Authorization (PUMA), and the Paediatric Investigation Plan (PIP). 2011 saw the release of the Geriatric Medicines Strategy by the European Medicines Agency (EMA), which also established the Geriatric Expert Group (GEG) and followed the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E7guideline. The Central government of India launched the National Policy for Older Persons in 1999. Organizations like the National Institute of Mental Health and Neurosciences (NIMHANS) are increasingly utilizing tele psychiatry services, especially geriatric tele psychiatry. Clinical studies involving children require adherence to ethical guidelines as specified by the Indian Council of Medical Research, in addition to regulatory guidelines. However, unlike the USA and EU, India lacks precise criteria for the development of paediatric and geriatric medicine.