Industry perspectives on ICH guidelines.

In 1990 the International Conference on Harmonization (ICH) effort was begun with the intent of standardizing the drug registration and approval process. The need to rationalize and harmonize regulation was driven by concerns over rising costs of health care, escalation of the cost of research and development and the need to meet the public expectation that there should be a minimum delay in making safe and efficacious new treatments available to patients in need. Since most regulatory agencies have limited resources to interact with sponsor companies, standardized guidelines would help expedite communications with companies at the programme design stage. The ICH is a joint initiative involving both regulators and industry as partners in scientific and technical discussions of the testing procedures which are required to ensure the safety and efficacy of medicines. While all regions of the world have some input to the process, the primary development of the guidelines is derived from industry and regulatory representatives from Europe, Japan and the United States. Much progress has been made in the ten years since the initiation of the ICH, but the implementation and maintenance of the guidelines are in the early stages for most if not all of the published guidelines. If the guidelines do not gain a solid foothold early on, then drift between the regions in use of the guidelines will defeat the goals of the ICH. While the ICH covers the entire drug development process, this paper will review the guidelines that pertain most closely to clinical trials and their use in the drug registration process. Some of the guidelines have been approved and some are still in the development stage.

Duke Scholars

Author Frank Wesley Rockhold Biostatistics & Bioinformatics, Division of Biostatistics