Journal of Pharmaceutical Investigation

The Korean Society of Pharmaceutical Sciences and Technology (한국약제학회)
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Revision of The Korean Pharmceutical Codex, The Third Edition

의약품 등 기준 및 시험방법(제 3개정) 소개

  • Choi, Myoeng-Sin (Department of Drug Evaluation, Department of Herbal Medicine Evaluation, Korea Food and Drug Administration) ;
  • Yang, Ji-Sun (Department of Drug Evaluation, Department of Herbal Medicine Evaluation, Korea Food and Drug Administration) ;
  • Yoo, Tae-Moo (Department of Drug Evaluation, Department of Herbal Medicine Evaluation, Korea Food and Drug Administration) ;
  • Kim, In-Kyu (Department of Drug Evaluation, Department of Herbal Medicine Evaluation, Korea Food and Drug Administration) ;
  • Kim, Hye-Soo (Department of Drug Evaluation, Department of Herbal Medicine Evaluation, Korea Food and Drug Administration) ;
  • Lee, Sun-Hee (Department of Drug Evaluation, Department of Herbal Medicine Evaluation, Korea Food and Drug Administration) ;
  • Chang, Seung-Yeup (Department of Drug Evaluation, Department of Herbal Medicine Evaluation, Korea Food and Drug Administration) ;
  • Cho, Jung-Hee (Department of Drug Evaluation, Department of Herbal Medicine Evaluation, Korea Food and Drug Administration) ;
  • Lee, Su-Jung (Department of Drug Evaluation, Department of Herbal Medicine Evaluation, Korea Food and Drug Administration) ;
  • Kim, Young-Lim (Department of Drug Evaluation, Department of Herbal Medicine Evaluation, Korea Food and Drug Administration) ;
  • Kim, Mi-Jeong (Department of Drug Evaluation, Department of Herbal Medicine Evaluation, Korea Food and Drug Administration) ;
  • Kim, Eun-Jung (Department of Drug Evaluation, Department of Herbal Medicine Evaluation, Korea Food and Drug Administration) ;
  • Lee, Jong-Pil (Department of Drug Evaluation, Department of Herbal Medicine Evaluation, Korea Food and Drug Administration) ;
  • Kim, Do-Hoon (Department of Drug Evaluation, Department of Herbal Medicine Evaluation, Korea Food and Drug Administration) ;
  • Baek, Kyung-Min (Department of Drug Evaluation, Department of Herbal Medicine Evaluation, Korea Food and Drug Administration) ;
  • Kim, Hee-Sung (Department of Drug Evaluation, Department of Herbal Medicine Evaluation, Korea Food and Drug Administration) ;
  • Park, Sang-Aeh (Department of Drug Evaluation, Department of Herbal Medicine Evaluation, Korea Food and Drug Administration) ;
  • Kang, In-Ho (Department of Drug Evaluation, Department of Herbal Medicine Evaluation, Korea Food and Drug Administration) ;
  • Kim, Eun-Kyung (Department of Drug Evaluation, Department of Herbal Medicine Evaluation, Korea Food and Drug Administration)
  • 최명신 (식품의약품안전청 의약품평가부, 생약평가부) ;
  • 양지선 (식품의약품안전청 의약품평가부, 생약평가부) ;
  • 유태무 (식품의약품안전청 의약품평가부, 생약평가부) ;
  • 김인규 (식품의약품안전청 의약품평가부, 생약평가부) ;
  • 김혜수 (식품의약품안전청 의약품평가부, 생약평가부) ;
  • 이선희 (식품의약품안전청 의약품평가부, 생약평가부) ;
  • 장승엽 (식품의약품안전청 의약품평가부, 생약평가부) ;
  • 조정희 (식품의약품안전청 의약품평가부, 생약평가부) ;
  • 이수정 (식품의약품안전청 의약품평가부, 생약평가부) ;
  • 김영림 (식품의약품안전청 의약품평가부, 생약평가부) ;
  • 김미정 (식품의약품안전청 의약품평가부, 생약평가부) ;
  • 김은정 (식품의약품안전청 의약품평가부, 생약평가부) ;
  • 이종필 (식품의약품안전청 의약품평가부, 생약평가부) ;
  • 김도훈 (식품의약품안전청 의약품평가부, 생약평가부) ;
  • 백경민 (식품의약품안전청 의약품평가부, 생약평가부) ;
  • 김희성 (식품의약품안전청 의약품평가부, 생약평가부) ;
  • 박상애 (식품의약품안전청 의약품평가부, 생약평가부) ;
  • 강인호 (식품의약품안전청 의약품평가부, 생약평가부) ;
  • 김은경 (식품의약품안전청 의약품평가부, 생약평가부)
  • Published : 2005.06.20
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Abstract

The aim of publishing the Korean Pharmaceutical Codex is to update and set specification of essential drugs for humane health. In accordance with speedy development of new drugs and improvement of science and technology, the need of revision of drug specification through the ICH guidelines and discussions between regulatory agency and pharmaceutical industry for the quality assurance of safer and efficient drugs is getting higher. The first edition of Korean Pharmaceutical Codex was published in 1983. Now, the third revision of the Codex is prepared because of the revision of domestic and foreign Pharmacopeias, changes of drug control environment, improvement of science and technology and so on. The aim of 3th edition is to improve the quality of essential drugs through the setting of the required specifications and discussions between the regulatory agency and pharmaceutical industry.

Keywords

References

  1. 대한약전 제8개정, 식품의약품안전청 (2002)
  2. British Pharmacopoeia 2004, Medicines Commission (2004)
  3. The United States Pharmacopeia 27, United States Pharmacopeial Convention Inc. (2004)
  4. 일본약국방 제14개정 해설서, 광천서점 (2001)
  5. European Pharmacopoeia 5.0, European Directorate for the Quality of Medicines (2004)