Abstract

N. Mounika Raja Rani*

ABSTRACT

The studies provide with the guidance to National Regulatory Authorities (NARES) and vaccine manufacturers on the clinical evaluation of vaccines by outlining international regulatory expectations during the different stages of vaccine development and for marketing approval. In this respect, the guidance in this document could also be useful for clinical researchers and investigators. The text is written in the form of guidelines instead of recommendations in view the fact that vaccines represent a heterogeneous class of agents, and the preclinical and clinical testing programmes will need to be adapted for the product in question. Guidelines allow greater flexibility than Recommendations with respect to specific issues related to particular vaccines. A separate WHO document is under development to provide more detailed guidance on preclinical and laboratory evaluation of vaccines. The section of this document that discusses preclinical and laboratory evaluation consequently provides general guidance but does not define international regulatory expectations in this area. Clinical trials (CTs) are conducted to explore new methods of intervention that are better than the existing ones and can also be easily tolerated by patients. CTs are conducted in accordance with the regulatory guidelines recommended for the same by the drug regulatory authority of the country where they have to be conducted. In this work, clinical trial regulations in USA, EU, India, and Singapore were compared on the basis of parameters such as regulatory bodies involved, regulations for CTs, clinical trial application format, application fee, approval time, the various forms required, role and responsibilities of IRB/IEC, record retention time, and GCP guidelines.