Clin Exp Vaccine Res.  2013 Jan;2(1):69-70.

Clinical trials for vaccine development in registry of Korea Food and Drug Administration

• Kang SY

Abstract

Based on the action plan "Ensuring a stable supply of National Immunization Program vaccines and sovereignty of biopharmaceutical products," Korea Food and Drug Administration (KFDA) has made efforts to develop vaccines in the context of self reliance and to protect public health. Along with the recognized infrastructures for clinical trials, clinical trials for vaccines have also gradually been conducted at multinational sites as well as at local sites. KFDA will support to expand six to eleven kinds of vaccines by 2017. In accordance with integrated regulatory system, KFDA has promoted clinical trials, established national lot release procedure, and strengthened good manufacturing practices inspection and post marketing surveillance. Against this backdrop, KFDA will support the vaccine development and promote excellent public health protection.

Keyword

Vaccine; Self-reliance; Clinical trials; Research and development

MeSH Terms

Immunization Programs
Korea
Marketing
Public Health
United States Food and Drug Administration
Vaccines
Vaccines

Figure

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  Fig. 1 The numbers of approved clinical trials for vaccines in registry of Korea Food and Drug Administration from 2006 to 2011.

Reference

1. Korea Food and Drug Administration. Food and drug statistical yearbook, 2011. 2011. Cheongwon: Korea Food and Drug Administration.

2. Korea Food and Drug Administration. Food and drug statistical yearbook, 2011 [Internet]. c2012. cited 2012 Nov 5. Cheongwon: Korea Food and Drug Administration;Available from: http://www.kfda.go.kr/index.kfda?mid=96&pageNo=1&seq=12217&cmd=v.