A Comparison of the Drug Review Process at Five International Regulatory Agencies

摘要

All agencies have the same objectives and obligations to safeguard public health when assessing the safety, quality, and efficacy of medicines before they are authorized for marketing. However, the structure, strategies, practices, processes, and regulatory and legal obligations in place at each agency in order to carry out a regulatory review and achieve these objectives vary considerably. From the pharmaceutical industry's perspective, the regulatory review of new medicines is the culmination of a research-and-development process that has taken between 10 and 12 years (1), and the outcome spells success or failure for a project that represents an Dollars 802 million investment (2).