Regulatory Issues for AIDS Vaccine Development
Jim Ackland
from: AIDS Vaccine Development: Challenges and Opportunities (Edited by: Wayne Koff, Patricia Kahn and Ian D. Gust). Caister Academic Press, U.K. (2007)
Abstract
The development and licensure of a successful HIV vaccine involves meeting various regulatory requirements that were put in place to protect individuals from unsafe or ineffective pharmaceutical products. Regulatory agencies such as the U.S. Food and Drug Administration (FDA), the European Agency for the Evaluation of Medicinal Products (EMEA) and the South African Medicines Control Council must approve vaccine products before they are tested in clinical trials or licensed for general use. Approval is based on a scientific assessment of risks and benefits, and involves a review of manufacturing, preclinical and clinical information. In this article I discuss possible ways to expedite regulatory approval at all stages of development and to involve regulatory agencies in the development process-important steps in reducing the time it will take until an effective HIV vaccine can become widely available read more ...
