Transformations In The Pharmaceutical Regulatory System: Opportunities And Challenges

• By: ALDAWSARI, Fahad S. (Saudi Food and Drug Authority (SFDA), Saudi Arabia)
• Co-author(s): Dr Fahad S. Aldawsari (Saudi Food and Drug Authority (SFDA), Riyadh, Saudi Arabia)
  
• Abstract:

  Introduction
  A typical pharmaceutical regulatory system comprises conventional activities such as medicine registration, surveillance & pharmacovigilance and laboratory compliance testing. However, there have been recent safety issues in medicines that have influenced society, in which common regulatory activities were not effective enough in mitigating these risks. In addition, new technological and digital tools are gaining attention in stimulating the existing regulatory system as well as establishing new regulatory opportunities.
  
  Purpose
  To investigate the new trends in medicines regulations among the world's leading regulatory systems in order to identify learning opportunities for pharmacists and also to provide academia with insights in order to update appropriate curriculums accordingly.
  
  Methods
  Thorough analysis of the announced strategic plans for regulatory systems in the countries of the United States, European Medicines Agency, Australia, Japan and Saudi Arabia was performed. In addition, scanning for the published research studies from those authorities was also attempted in order to identify research directions and potential areas for enhancing pharmacists' skills.
  
  Results
  Three key areas for the new era of medicine regulations were identified, namely: digital health, partnership-collaboration and regulatory-driven scientific research. Moreover, special focus was given to biopharmaceuticals within the context of these areas owing to the future of medicinal therapeutics, taking the COVID-19 pandemic as a drive for this wave.
  
  Conclusions
  The new generation of pharmacists are encouraged to broaden their knowledge on the use of scientific tools (e.g. artificial intelligence, data analysis, and biostatistics), and how to incorporate these concepts within the essence of the pharmaceutical sciences arena. Academia is encouraged to embed these areas of learning into their curriculum for better preparation of pharmacists to embark the challenges in regulatory ecosystem.