Re-examination system for new drugs in Korea

Research output: Contribution to journalArticleResearchpeer-review

2 Citations (Scopus)

Abstract

The process for a new drug approval in Korea is very similar to that in the United States. Pharmaceutical company should submit all the relevant data on the safety and efficacy of the potential new drug including preclinical experimental data and clinical trial data. The re-examination system for new drugs has been effective since Jan 1, 1995. According to the guideline, pharmaceutical company should submit the predetermined number of safety data on the new drug after 4 or 6 years since it was approved to be marketed from the government. The purpose of this paper is mainly for explaining the concept and methods for effective conduction of the re-examination process. And the secondary purpose is to suggest the need and possible solutions for developing more proper drug safety evaluation system in Korea.

Original languageEnglish
Pages (from-to)3-15
Number of pages13
JournalJournal of Korean Society for Clinical Pharmacology and Therapeutics
Volume6
Issue number1
StatePublished - 1 Dec 1998

Fingerprint

Korea
Pharmaceutical Preparations
Safety
Drug Approval
Drug Evaluation
Clinical Trials
Guidelines

Keywords

  • Korea
  • New drugs
  • Re-examination system
  • Safety

Cite this

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Re-examination system for new drugs in Korea. / Park, Byung Joo.

In: Journal of Korean Society for Clinical Pharmacology and Therapeutics, Vol. 6, No. 1, 01.12.1998, p. 3-15.

Research output: Contribution to journalArticleResearchpeer-review

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AU - Park, Byung Joo

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