CURRENT LAWS GOVERNING COMPARATIVE STUDIES AND CLINICAL TRIALS IN INDIA, THE UNITED STATES, EUROPE, AND SINGAPOREAbstract
Clinical trials (CTs) are carried out to investigate novel, patient-acceptable, and more effective interventional procedures. Specific regulatory criteria for conducting CTs are recommended by the country’s drug regulatory authority, and these guidelines are followed when conducting CTs. The USFDA oversees regulating CTs in the USA in accordance with the Federal Food, Drug, and Cosmetic Act’s 21 Code of Federal Regulations, Part 312 (CFR). According to the GCP Directive 2005/28/EC of the 8 April 2005 and the CT Directive 2001/20/EC of the European Parliament and of the Council of the 4 April 2001, they are under the control of the European Commission and EMA in the EU. Both the ICMR and the CDSCO (Schedule Y, D&C Act) have control over the Ethical Guidelines for Biomedical Research on Human Subjects. The European Commission’s objective of promoting an environment that is suitable to CTs within the EU is to be realised with the help of the Clinical Trials Regulation (CTR) (No. 536/2014). All interventional CTs involving medicines for human use that are done in the EU going forward must comply with the CTR legislation. It strives to harmonise submission and evaluation procedures, raise overall safety standards, and enhance cooperation and transparency within and among Member States. Compared to India and Singapore, the USA and Europe have a greater success rate for CTs, which may be attributable to highly competent researchers, a quick regulatory approval process, and eager subject volunteers. Also, several case studies pertaining to the CTs are carried out in these nations.
P. Kala Sree, S. Princely Ebenezer Gnanakani *, K. P. S. Praneetha and G. Sumalatha
Department of Pharmaceutical Biotechnology, Vikas Institute of Pharmaceutical Sciences, Rajahmundry, Andhra Pradesh, India.
12 January 2023
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