(2002; 166 pages)
Regulation of biotechnology products in the Republic of Korea
Dr Won Shin, Republic of Korea
The Korean Food and Drug Administration (KFDA) regulates biotechnology and medicinal products in the Republic of Korea. KFDA has three subsidiary institutes that are involved in the control of biologicals:
• The Pharmaceutical Safety Bureau handles all the administrative and regulatory processing of submissions, new drug applications, postmarketing surveillance, GMP inspections, and all compliance actions, such as product recall, issuance of regulatory letters, and revocation of product licences.
• The Biologics Evaluation Department evaluates the chemistry, manufacture and construction of application dossiers, does post-GMP inspections, performs official laboratory release tests of biologicals, and conducts laboratory searches to facilitate the scientific review process.
• The National Institute of Toxicological Research evaluates the pharmacology, toxicology and clinical data section of the application and conducts laboratory work in its areas of expertise.
There are regulations relating to registration of biologicals: GLP, GCP, and GMP apply to all product development; and manufacturers should have a manufacturing licence for their production facilities. They, as well as the importers, should obtain product licences after the KFDA’s evaluation of safety, efficacy and quality. There is also postmarketing surveillance, an adverse reaction monitoring system and an annual programme of sampling and testing of products on the market.
In conclusion, KFDA tries to implement science-based regulations compatible with ICH and global standards, and also to facilitate domestic and global drug development.