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 65
- Downloads 0
Oral Midazolam and Ketamine as Premedicants in Children- A Randomized Open Label Single Centre Study
Operation theatre and emergency room environment induces fears in a child which include those due to separation from parents, of pain, fear of the unknown and unfamiliar environment and fear due to loss of control and pr...
Anticoagulants Effect on the platelets Rich Plasma Growth Factors Levels
Background: Platelet-rich plasma (PRP) are platelets concentrates made of autogenous blood with a high number of platelets in a small volume of plasma. The main component that appears to be associated with the therapeuti...
Occupational Therapists Perspective in Wound Care Management
Occupational Therapists play a major role in prevention and management in skin and wound care. Wounds and injuries can restrict persons participation in day to day activities e.g. Self care. Wounds can be of physical Inj...
Myocardial Protection in Aortic Valve Replacement with Severe Aortic Stenosis: A Comperative Study between Del Nido and HTK Solution
Both Delnido and HTK Cardioplegia provides excellent myocardial protection and reduces the frequency of cardioplegia administration which allows uninterrupted operation and also reduces ‘x’-clamp timing. Both helps smoot...
Comparative Study of Incidence of Posterior Capsular Opacification between Pmma and Hydrophobic Acrylic Intraocular Lens Implantation in Senile Cataracts
Introduction: Posterior Capsular Opacification is due to growth and abnormal proliferation of lens epithelial cells over the posterior capsule which migrate towards the visual axis causes obscuration of vision. Aim: To c...