International Conference Of Regulatory Agencies And...

Abstract Representatives of regulatory agencies and industries from Europe (EU), Japan, and the United States (US) met together in the International Conference of Harmonization (ICH) and issued guidelines in conducting clinical trials including the of Good Clinical Practice (GCP) guideline. Quality, safety, and efficacy were set as the three basic criteria to approve new medical products which reflect the state-of-the art technology. ICH-GCP guideline was adopted by regulatory agencies of the EU, US, and Japan including the US Food and Drug Administration (US FDA), which has established regulations of GCP to enhance its oversight on clinical trials involving humans, and offer detailed information for interested parties such as the sponsor,†¦show more content†¦In addition, the ICH-GCP guideline addresses the requirements and duties of all parties involved in clinical trial conduction such as the sponsor, investigators, and ethics committees, and stated that compliance with the GCP mu st be a shared responsibility among all parties (Mueller, Schellenberg, Owens, 2007). This guideline was incorporated in Title 21 of the Code Federal Regulations (21 CFR) in 1997, and adopted by the United States Food and Drug Administration (US FDA) to be implemented in designing, conducting, monitoring, auditing, recoding, analysis, and reporting clinical trials to ensure that the documentation of reporting data are credible and accurate, and more importantly to provide safeguards for protecting the rights, safety, privacy, and confidentiality of participants (Allen Vandenburg,1992). The 21 CFR regulations are updated annually in order to adapt with any emergent issues that require specific changes to ensure the ethical and scientific quality of clinical trials. In addition, these regulations are mandatory on all FDA-regulated products, and rigorous penalties are applied in case they have been violated (Allen Vandenburg,1992). 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