Pharmaceutical regulations need to move from reactive to proactive to keep pace with the rapid rise of emerging technologies and novel modalities.
By Nina S. Cauchon, Ph.D., R.A.C., Amgen Inc.; Edward Narke, R.A.C., DS InPharmatics; and Susan Ohorodnik, Ph.D., Envigo
The use of medicinal products to cure ailments has its roots in antiquity, but our philosophy on ensuring their suitability has evolved gradually over time, with initial regulations being developed due to public safety concerns, often in response to tragic events. As pharmaceutical companies pursue new therapies to address increasingly complex medical needs, they face a storm of challenges to their ability to achieve success with development, registration, and international market viability. There is renewed interest in reducing the burden of regulation and in stimulating research and development while maintaining standards for quality, safety, and efficacy. This article provides a brief discussion of the past, present, and possible future of pharmaceutical regulations. It is a story of continuous change, between industry and regulators as well as interactions across global health agencies.