Abstract

Background: Clinical trial is vital step in the development of new and safe medicine & in the improving medical treatment. Clinical trial explore how a treatment reacts in the human body and are designated to ensure a drug is treated and effective before by regulatory authority and made available for doctors. The clinical trial approval or submission is the dossier that includes all documentation pertaining to the conduct of clinical trial in [country] according to the regulation. The clinical trial application must undergo a review or evaluation before being granted authorisation to conduct the trial in [COUNTRY] by [NAME OF NATIONAL REGULATORY AUTHORITY]. Drug trial regulation systems differs among countries and at this stage full harmonisation of the processes among the different International Conference of Harmonization of technical requirements for registration of pharmaceutical product for human use (ICH) regions of the world.

Methods: In this study, a methodology based on research articles, research journals, countries legal website and scientific publications have provided a basis for detailed analysis of timelines for clinical trial review and approval of eight regulatory authorities. This research shows that the various timelines and requirements of clinical trial approval process. Clinical trial regulatory guidelines of India compared with European Union, Canada, China, US, UK and Kenya and Australia. Timelines of clinical trial approval process and its requirements in India were compared with other respective countries.

Results: This study specifies various regulatory guidelines and safety requirements for conduct and inspection of clinical trials. It is required to take grant permission from regulatory authority to conduct clinical trial. The regulatory environment in USFDA, Kenya and Canada becomes more stringent in terms of timelines of approval.

The information regard to clinical trial application approval (CTA) obtained from the official website of different countries; those were used to compare timelines and requirements of clinical trial approval process in India with EU, US, UK, China, Canada, Kenya and Australia. The flowcharts were prepared to compare timelines & requirements of safety reporting in India with respective countries. Total eight regulatory authorities were included in this study which shows the different timelines and requirements for clinical trial approval process.

Conclusions: The regulatory guidelines in the clinical trials vary between countries. And it is important to take permission from regulatory authority before conducting clinical trial. Under the regulation, sponsor will be required to apply for authorisation to conduct clinical trial. 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  indifferent  stages  of  the  review.

Keywords: Regulatory authorities, Clinical trial approval process, Timelines and requirements of CTA.