Table 1.
Guidelines relevant to clinical evaluation of vaccines
| Name of guideline | Remarks |
|---|---|
| ICH: E6: Guideline on Good Clinical Practice | An international ethical and safety quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects |
| Good Clinical Practice Guidelines for Clinical Research in India | To ensure uniform quality of clinical research throughout the country and to generate data for registration for new drugs before use in the Indian population |
| ICH: E8: General Consideration for Clinical Trials | Describes internationally accepted principles and practices in the performance of both individual clinical trials and overall development strategy for new medicinal products |
| Schedule Y: Requirements and Guidelines for Permission to Import and/or Manufacture of New Drugs for Sale or to Undertake New Trials | Schedule Y is the CDSCO-enforced law in India established under the Drugs and Cosmetics Act, 1945. This regulation is followed when conducting clinical trials in India |
| Annex 1: WHO Guidelines on Clinical Evaluation of Vaccines: Regulatory Expectations | Guidelines for national regulatory authorities, vaccine manufacturers, clinical researchers, and investigators |
| Guidelines on Clinical Evaluation of New Vaccines (EMEA/CHMP/VWP/164653/2005) | Provides guidance on the design of clinical development programs for new vaccines that are intended for pre- and postexposure prophylaxis |
| Guidelines on Adjuvants in Vaccines for Human Use (EMEA/CHMP/VEG/134716/2004) | Addresses the quality, nonclinical, and clinical issues arising from the use of new or established adjuvants in vaccines |
| Brighton Collaboration | Provides case definition documents that are intended to standardize collection, analysis, and presentation of vaccine safety data following immunization |
| Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA/CBER/ 2007) | Provides sponsors, monitors, and investigators of vaccine trials, with recommendations on assessing the severity of clinical and laboratory abnormalities in healthy adult and adolescent volunteers enrolled in clinical trials |
| ICH: E9: Statistical Principles for Clinical Trials | Intended to give direction to sponsors in the design, conduct, analysis, and evaluation of clinical trials of an investigational product in the context of its overall clinical development |
| ICH: E3: Structure and Content of Clinical Study Report | Compilation of clinical study report in a format acceptable to all regulatory authorities of ICH region |
CDSCO = Central drug standard control organization