Dr Azizah Ab Ghani is a senior pharmaceutical regulatory professional and the Head of Biologics at the National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia. With nearly 30 years of service in the Ministry of Health and extensive experience in the regulation of biological products, she provides regulatory leadership and technical oversight for the assessment and lifecycle management of biologics, vaccines, biosimilars and cell and gene therapy products (CGTPs).
Her regulatory work includes the development of national regulatory guidance, implementation of facilitated and expedited registration approaches, and participation in regional regulatory collaboration and harmonisation initiatives. Her experience includes work related to Facilitated Registration Pathways (FRP), ASEAN Joint Assessment, and expedited regulatory processes and guidance developed during the COVID-19 pandemic. These activities reflect her practical perspective on balancing timely access to innovative and needed health products with robust quality, safety and efficacy requirements.
She holds a PhD in Pharmacology from the University of Liverpool, United Kingdom. Her professional interests include risk-based regulation of advanced therapies, regulatory convergence, reliance and work-sharing, and the development of sustainable regulatory frameworks that protect patients while supporting timely access to innovation.
