Development and Establishment of Good Review Practices for Drug Products in Korea
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Young-Ok Kim, PhD, Team Leader Korea Food and Drug Administration In-Sook Park, PhD, Deputy Team Leader, Senior Reviewer Korea Food and Drug Administration So-Young Wang, MS, Reviewer Korea Food and Drug Administration Hwa-Kyung Lim, PhD, Reviewer Korea Food and Drug Administration So Hee Kim, PhD, Deputy Team Leader, Senior Reviewer Korea Food and Drug Administration Joo Hyeun Lee, PhD, Reviewer Korea Food and Drug Administration Mi Jeong Kim, PhD, Deputy Team Leader, Senior Reviewer Korea Food and Drug Administration Kyung-Eun Youn, MS, Reviewer Korea Food and Drug Administration
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Development and Establishment of Good Review Practices for Drug Products in Korea Good review practices (GRP) for drug products are a system to ensure the consistency, transparency, fairness, and objectivity of the review process. To this end, the standardized guidelines on process and procedures for the review of drug products were developed for efficient conduct of the review process, and ongoing training activities were conducted to improve the expertise level of reviewers. Since the introduction of the GRP system in 2004, the Korea Food and Drug Administration has initiated various research activities to reflect the results in the review process. Major accomplishments arising from the introduction of the GRP are as follows: (1) standardized review forms for various review areas and guidelines on considerations in reviewing drug products were developed to improve the
efficiency and effectiveness of the review process; (2) the review-related regulations were newly developed or revised and guidelines were published to ensure the consistency and fairness of the review process; (3) the procedure for disclosure of review results was developed and various data and information have been disclosed to the public to improve the transparency and reliability of the review process and results; and (4) training programs for reviewers have been developed and implemented to improve the expertise level of reviewers and ensure reliable review results. In addition, a road map for the GRP system was developed, which has been systematically executed to improve the quality of the review process and confidence in the review results.
Yun Hee Lee, PhD, Reviewer Korea Food and Drug Administration Su-Jung Lee, PhD, Deputy Team Leader, Senior Reviewer Korea Food and Drug Administration Dong Sup Kim, PhD, Director Korea Food and Drug Administration Inkyu Kim, PhD, Team Leader Korea Food and Drug Administration Bo-Kyung Choi, PhD, Team Leader Drug Evaluation Department, Pharmaceuticals Headquarters, Korea Food and Drug Administration, Seoul, Korea
Key Words Good review practices; Korea Food and Drug Administration; Review template; Standardized guidelines; Training programs Correspondence Address Bo-Kyung Choi, Antibiotics and Oncology Team Drug Evaluation Department, Pharmaceuticals Headquarters, Korea Food and Drug Administration, 194 Tongil-ro Eungpyung-gu, Seoul 122-704, Korea (email: [email protected]).
INTRODUCTION The pharmaceutical industry is a
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