RESEARCH ARTICLE ON REGULATORY REQUIREMENTS FOR CLINICAL TRIAL APPROVAL PROCESS AS PER CDSCO IN COMPARISION WITH NETHERLAND

*Dr. P. Ashok Kumar, Arpitha P., Bhavana C. N., Bhavyashree D. N., Chandana M., Thejashwini H. J.

ABSTRACT

Clinical trials provide evidence on the safety and efficacy of medicines and require regulatory oversight to protect participants and ensure ethical research. In India, clinical trials are regulated by CDSCO, the Central Licensing Authority, NDCTR 2019, Ethics Committees, and CTRI. Applications are submitted through the SUGAM portal and undergo regulatory and ethical review before approval. Compliance with GCP, informed consent, safety reporting, monitoring, and trial completion requirements is essential.In the Netherlands, clinical trials involving medicinal products are governed mainly by the European Union Clinical Trials Regulation (EU) No. 536/2014 and are submitted through the Clinical Trials Information System (CTIS). Ethical oversight is provided by the Central Committee on Research Involving Human Subjects (CCMO) or accredited Medical Research Ethics Committees (MRECs), while the Medicines Evaluation Board (MEB/CBG-MEB) contributes to medicinal-product assessment.The comparison demonstrates that both countries emphasize participant safety, ethical review, scientific validity, GCP compliance, and continuous safety monitoring. However, their regulatory structures differ, with India following a predominantly national framework and the Netherlands operating within a harmonized European regulatory system through CTIS. Understanding these similarities and differences is important for investigators and sponsors planning clinical trials across jurisdictions. Effective regulatory oversight ultimately requires scientific rigor, independent ethical evaluation, transparent procedures, efficient electronic submission systems, risk-based monitoring, and continuous protection of trial participants.

Keywords: Clinical trials, CDSCO, CCMO, MEB, CTIS.