Comparison of regulatory framework of clinical trial with genetically modified organism-containing vaccines in the Europe, Australia, and Switzerland
10.7774/cevr.2021.10.2.93
- Author:
Jobin JOSE
1
;
Swathi PAI
Author Information
1. N.G.S.M. Institute of Pharmaceutical Sciences, NITTE Deemed to be University, Mangalore, India
- Publication Type:Review Article
- From:Clinical and Experimental Vaccine Research
2021;10(2):93-105
- CountryRepublic of Korea
- Language:English
-
Abstract:
New vaccines production and manufacture have revolutionized by recombinant technology. Various regulatory associations are engaged with the appraisal of a clinical trial with genetically modified organisms. At present safe, effective vaccines are needed in order to control the various emerging diseases which are a major cause of mortality. In reality, most vaccines raise biosafety worries with respect to human wellbeing. “Federal Office for Environment” is the competent authority for environmental risk assessments in Switzerland. Gene Technology Act 2000 is the fundamental direction that provides the necessary information to carry the clinical trials with genetically modified organism-containing vaccines. In addition, regulatory framework for “clinical trial with genetically modified organisms-containing vaccines” is stringent and partially harmonized in Switzerland, the European Union and Australia. In this study, we mainly concerned with regulatory aspects of “clinical trial with genetically modified organism” containing vaccine in three regions. This review includes various aspects like ethics, guidelines related to clinical trials of vaccines with genetically modified organisms.
