Abstract

Pharmaceutical governance is the cornerstone of ensuring medicine safety, efficacy, quality, and equitable access, particularly as health systems worldwide transition toward patient-centered pharmaceutical care. In Pakistan, the Drug Regulatory Authority of Pakistan (DRAP), established under the DRAP Act 2012, has made notable strides through recent reforms, including the 4th edition of the National Pharmacovigilance Guidelines (2025), mandatory electronic adverse event reporting via the Med Vigilance platform, full adoption of PIC/S Good Manufacturing Practice (GMP) standards, and accelerated implementation of serialization/2D barcoding for traceability. Nevertheless, systemic challenges persist: a high prevalence of substandard and falsified medicines, heavy dependence on imported active pharmaceutical ingredients (APIs), regulatory capacity constraints, and incomplete integration of pharmacist-led, outcome-focused care models. This structured narrative review critically examines Pakistan’s regulatory framework against international benchmarks set by the World Health Organization (WHO), International Council for Harmonization (ICH), U.S. Food and Drug Administration (FDA), and European Medicines Agency (EMA). It identifies persistent gaps and offers evidence-based, actionable recommendations to accelerate alignment with contemporary patient-centered paradigms.