A comparison of regulatory approval of clinical trial protocol with different countries

K. Amaresh, Geetanjali Salimath, M. S. Ganachari, Revana S. Devarinti, Uday Kumar


In present scenario, different countries must follow different regulatory requirements for protocol approval process of new drug application. Present study, we studied the regulatory requirements, timelines of approval and guidelines according to central drug standard control organization (CDSCO), therapeutic goods administration (TGA), food and drug administration (FDA) and European medical agency (EMA). The objective was to compare the regulatory approval of clinical trial protocol process. A comparative observational study was undertaken among the clinical trials and regulatory bodies of India (CDSCO), Australia (TGA), US (USFDA), Europe (EMA). The study specified various regulatory guidelines and safety requirements for conduct and inspection of clinical trial. Clinical trial protocol guidelines the essential documents are determined, and various timelines are being identified. And compared with the fees with other countries. Indian payments were compared with other countries. Timelines with safety reporting were compared with other 3 countries (Europe, Australia and US). The regulatory guidelines in the clinical trial different between countries. There is different timelines and requirements of clinical trial application approval process for each regulatory body. This study methodology has enabled comparisons to be made both within agencies and between different authorities and has identified differences in the timelines that applications spend in different stages of the review.



RA guidelines and requirements, FDA, TGA, EMA, CDSCO, Clinical trial approval process, Timelines and requirements of CTA

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