Development and Establishment of Good Review Practices for Drug Products in Korea

Abstract

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.