Comparision of Clinical Trial Application Approval Process with different countries guidelines
Journal Title: Journal of Medical Science And clinical Research - Year 2018, Vol 6, Issue 2
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
Authors and Affiliations
Miss Snehal Somana Wandre
Keywords
Related Articles
- EP ID EP506157
- DOI -
- Views 69
- Downloads 0
Hemodynamic Response in Hypertensive Patients with Endotracheal intubation and Laryngeal mask airway- A Comparative study
The haemodynamic response associated with laryngoscopy and tracheal intubation may be harmful to certain patients. The laryngeal mask airway (LMA) avoids the need for laryngoscopy and allows positive pressure ventilation...
Prevalence of Generalized Anxiety Disorder among the Patients Attending a Peripheral Health Center in Kashmir Valley
Background: Anxiety disorder is one of the common mental disorders emerging in the current world. Among all type of anxiety disorder the prevalence of generalized anxiety disorder is around 1-5% among Indian population....
The Deadly Scales
Here we present a case of 50 year old male suffering from psoriasis vulgaris, presented with central chest pain radiating to left arm. On evaluation the patient’s ECG showed ST elevation in anterior leads – hence diagnos...
Assessment of Services at Primary Health Centers in a District of Kashmir Valley
The importance of Primary Health Care was internationally known after Alma Ata Conference in 1978.Primary health care in India is delivered by Sub center and Primary Health Center. Primary Health Center is the first cont...
A Clinical Scenario of Corneal Ulcer in A Rural Based Hospital
Purpose: Corneal ulcer is one of the major causes of blindness in developing countries Predisposing factors related to corneal ulcer are trauma, chronic ocular surface disease, contact lens usage, ocular surgery, corneal...