Journal of Developing Drugs
Open Access

Department of Pharmaceutical Sciences, University of Copenhagen, Copenhagen, Denmark

Publications

• Opinion   
  Regulatory Affairs Should Be Viewed as a Driver of Innovation Rather Than a Barrier to Drug Development
  Author(s): Abigail Hughes*
  
  The journey from laboratory discovery to an approved medicine is one of the most demanding processes in modern science. It requires years of research, substantial financial investment and rigorous evaluation before a treatment becomes available to patients. Amid this complex process, regulatory affairs are frequently portrayed as an obstacle that slows pharmaceutical innovation. While lengthy reviews and extensive documentation may appear burdensome, I believe this perception overlooks the broader value of regulatory science. Regulatory affairs should not be viewed merely as a compliance function; Instead, they should be recognized as a fundamental contributor to scientific quality, f approaches seek to optimize the evaluation process while maintaining robust evidence requirements. Another important function of regulatory affairs is improving the quality of pharmaceutical research its.. View More»
  

  Abstract PDF