Proceedings of the Tenth International Conference of Drug Regulatory Authorities (ICDRA) - Hong Kong, China, 24 - 27 June 2002
(2002; 166 pages) View the PDF document
Table of Contents
View the documentAbbreviations and acronyms used in this report
Open this folder and view contentsOpening ceremony
Open this folder and view contentsHerbal medicines
Open this folder and view contentsKeynote address
Open this folder and view contentsSafety of blood-derived products
Open this folder and view contentsAntimicrobial resistance - new initiatives
Open this folder and view contentsHarmonization I
Open this folder and view contentsHarmonization II
Open this folder and view contentsProtection of trial subjects in clinical trials
Close this folderRegulating biotechnology products
View the documentComparability of biotechnology products and cell substrates
View the documentAssessing biocomparability: a Canadian perspective
View the documentRegulatory aspects of nucleic acid vaccines
View the documentReport on WHO Monitoring Group on Gene Therapy
View the documentRegulating biotechnology products: Cuban experience
View the documentRegulation of products derived from recombinant DNA technology in China
View the documentRegulation of biotechnology products in the Republic of Korea
View the documentRegulation of biotechnology products in Indonesia
View the documentRecommendations
Open this folder and view contentsRegulatory challenges: health sector reform and drug regulatory capacity
Open this folder and view contentsAccess to drugs and vaccines I
Open this folder and view contentsAccess to drugs and vaccines II
Open this folder and view contentsCounterfeit pharmaceutical products
Open this folder and view contentsHomoeopathy
Open this folder and view contentsSafety monitoring
Open this folder and view contentsE-Commerce
Open this folder and view contentsCurrent topics
Open this folder and view contentsRegulatory challenges of new technologies
View the documentList of participants
View the documentBack cover
 

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.

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