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.
LeeHKimCShinSG. Changes in clinical trial practice and the working environment in the Korean pharmaceutical industry since the implementation of Good Clinical Practice. Drug Inf J.2001;35:203–210.
2.
LeeHLimKWParkJHA survey of industrial perspectives on the Central Pharmaceutical Affairs Council's review of clinical trial protocols and study reports. Kor J Clin Pharmacol Ther.1998;6(1):11–28.
3.
The Korea Food and Drug Administration needs more experts for the drug review and approval process. The Yakup Daily. Feb 27, 2003.
4.
The quality of the review process, (editorial)Reg Aff J.2000:913–916.
5.
International Conference on Harmonisation. E6: Good Clinical Practice Consolidated Guideline (Step 4). Geneva, Switzerland: International Conference on Harmonisation; 1996.
6.
The quality of the review process: Industry and regulators deliberate. CMR Int News.2001;18:22–24.
7.
SmithND. Good Review Practices. Presented at the DIA Meeting Progress in Clinical Trials, February 14, 2004, Tokyo, Japan.
8.
RarickL. Giving your NDA submission the best chance of approval: The importance of presentation. Presented at the Drug Information Association 37th Annual Meeting, July 10, 2001, Denver, CO.
9.
LeskoLJWilliamsR. The Question-Based Review, A conceptual framework for Good Review Practices. Appl Clin Trials.1999;8(6):56–62.
10.
U.S. Food and Drug Administration Task Force on Risk Management.Managing the Risks from Medical Product Use—Creating a Risk Management Framework.Rockville, MD: U.S. Food and Drug Administration Task Force on Risk Management; 1999.
The U.S. Congress.The Prescription Drug User Fee Act of 1992. 1992.
13.
The U.S. Congress.The Prescription Drug User Fee Act of 1997. 1997.
14.
The U.S. Congress.The Prescription Drug User Fee Amendments of 2002 In: The Public Health Security and Bioterrorism Preparedness and Response Act of 2002. 2002.
15.
U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Reviewer Guidance (Draft). Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review.Rockville, MD: U.S. Food and Drug Administration, Center for Drug Evaluation and Research; 1996.
16.
U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for Reviewers. Pharmacology/Toxicology Review Format.Rockville, MD: U.S. Food and Drug Administration, Center for Drug Evaluation and Research; 2001.
17.
U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Procedures for Assessments Performed by the Quality Assurance Staff. Manual of Policies and Procedures: Center for Drug Evaluation and Research. MAPP 4112.4. Rockville, MD: U.S. Food and Drug Administration, Center for Drug Evaluation and Research: 2004.
18.
RarickL. The CDER 2001 Good Review Practices initiative (clinical). Presented at the Drug Information Association 37th Annual Meeting, July 10, 2001, Denver, CO.
19.
OrtwerthM. The CDER 2001 Good Review Practices initiative—A general overview. Presented at the Drug Information Association 37th Annual Meeting, July 10, 2001, Denver, CO.
20.
LeeJS. A Proposal for New Pharmaceutical Affairs Laws in Korea to Modernize Pharmaceutical Products Management. Presented at the Korean Society of Pharmaceutics 3rd Soyang Conference, August 20, 2004, Chuncheon, Korea.
KimSY. To become a strong biopharmaceutical nation. The JoongAng Daily. July 16, 2001.
23.
JeonMS. If Korea Food and Drug Administration does not reform itself, Korea will be left out of the Asian clinical trial markets within three years. Interview with Prof. Sang-Goo Shin. Korean Pharma J. March 29, 2004.
24.
YooTM. Introduction to organization and job description: The Department of Drug Evaluation. Presented at the Public Forum for New Drug Review Procedures by the Korean Food and Drug Administration, Seoul, Korea, March 18, 2004.
25.
JeonMH. Korea Food and Drug Administration to facilitate and streamline drug review processes. More information will be made publicly available. The Daily Pharma. March 19, 2004.
26.
LeeDHNamSY. Clinical trial systems in developed countries. Korean J Pharma Med.2004;2(1): 10–17.
Center for Devices and Radiological Health, The Food and Drug Administration. Third-Party Review. Available at: http://www.fda.gov/cdrh/thirdparty/. Accessed September 17, 2004.
29.
KimCJ. Development of clinical trials—why it is necessary and how it can be achieved. J Korean Med Assoc.2003;46(12):1064–1069.
