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Good Review Practices: The First Step Forward for the Korea Food and Drug Administration

Good Review Practices (GRPs) are defined as drug regulatory reviewers' adherence to pre-specified standards in terms of content and process. GRPs ensure the capture of important information in the review, enabling the standardization of reviews across divisions and disciplines, which results in consistent assessment over the drug development period. Although the Korea Food and Drug Administration has enacted many global standard clinical trial regulations since the late 1990s, it needs more transparent procedures, clearly documented and communicated to the sponsor, with agency wide commitments for recruiting and training quality reviewers. Therefore, establishing GRPs as review standards should be the first step for the Korea Food and Drug Administration. Additionally, third-party clinical review was proposed as an alternative to the current government-centered review system given the difficulty of hiring in-house clinical reviewers for the Korea Food and Drug Administration.