Current Regulatory requirements for conducting Cinical trials
Current Regulatory requirements for conducting clinical trials.
Before a drug may be licensed for import, manufacturing, or marketing in the country, it must first demonstrate that it is safe and effective for human use. The Drugs and Cosmetics Rules, Rules 122A, 122B, and 122D, as well as Schedule Y’s Appendix I, IA, and VI, explain the information/data required for approval of clinical trials and/or the import or production of new drugs for marketing in the country. Recently, there are several adjustments made relating to the new drug rules. & “ New Drugs and Clinical Trial Rules, 2018. The CDSCO has published a (draught) document. This course will provide participants with a comprehensive understanding of the current regulatory and ethical standards for conducting clinical trials.
Syllabus for Current Regulatory requirements for conducting clinical trials.
Week 1: Overview, Definitions, and Drug Regulatory Agencies
Week 2: Drugs and Cosmetics Act and Rules (Applicable Acts and Rules), Drugs and Cosmetics Rules (Applicable CDSCO Guidelines), Drug Development Overview
Schedule Y: Overview, Schedule Y: Appendices,
Week 3: Good Clinical Practice (Indian), Schedule Y: Overview, Schedule Y: Appendices
Week 4: Ethical issues, recent revisions, and special concerns (Approval procedure for Medical device, Biologicals, Phytopharmaceuticals, rDNA derived products)