Comparison of Clinical Trials Requirements and Procedures in Various Contries

Abstract

Currently, several nations have distinct regulations to adhere to in order to approve new medication applications through regulatory protocol. In the current study, we looked at the guidelines, timescales for approval, and regulatory standards set forth by the Central Drug Standard Control Organization (CDSCO), European Medical Agency (EMA), Therapeutic Goods and Administration (TGA), Food and Drug Administration (USFDA) and the Health Canada (HC). Comparing the clinical trial protocol approval process with regulatory approval was the aim of the study. An observational comparative analysis was conducted between clinical trials and the regulatory agencies in Europe (EMA), the US (USFDA), Australia (TGA), India (CDSCO) and Canada (HC). The study outlined a number of safety regulations and regulatory recommendations for the administration and oversight of clinical trials. Guidelines for clinical research protocols, the crucial documents are recognized, and different deadlines are noted and contrasted with the charges in other nations. Indian payments were contrasted with those from other nations. The safety reporting timelines of the US, Europe, Australia, and Canada were compared with India. The clinical trial's regulatory guidelines vary depending on the nation. Every regulatory agency has a different approval process for clinical trial applications, with varying deadlines and specifications. This study's methodology has made it possible to compare applications between agencies and between authorities as well as identify variations in the amount of time applications spend at each stage of the review process.