Herbal medicines occupy a unique position in global healthcare, combining traditional knowledge with modern therapeutic use. As their popularity grows across regulated markets, particularly in Europe, the need for robust quality control and scientific validation has become increasingly important. To address this, international frameworks developed by the European Union (EU), the International Council for Harmonisation […]
The global demand for herbal medicines and traditional systems of healthcare has increased rapidly in recent decades. With this growth comes a heightened responsibility to ensure that herbal drugs are safe, effective, and of consistent quality. Quality assurance in the herbal drug industry integrates scientific principles with traditional knowledge, supported by international standards such as
Quality control is the foundation of safe and effective healthcare. Before any drug—whether synthetic, herbal, or finished dosage form—reaches patients, it must undergo rigorous testing to confirm its identity, purity, strength, and safety. Basic tests for drugs play a critical role in preventing substandard, adulterated, or counterfeit products from entering the supply chain. With the
As pharmacovigilance evolves, the focus is shifting from a “one-size-fits-all” approach to more personalized and population-specific safety monitoring. Pharmacogenomics, evaluation of drug safety in special populations, and harmonized regulatory frameworks now play a crucial role in understanding and preventing adverse drug reactions (ADRs). At the same time, global and national bodies such as CIOMS and
Safety data generation is the backbone of pharmacovigilance, ensuring that medicines remain safe from early discovery through real-world use. Modern drug regulation relies on a continuous flow of safety information generated during preclinical testing, clinical trials, and post-approval monitoring. These activities are globally harmonized through International Council for Harmonisation (ICH) guidelines, which provide a common
Vaccines are among the most effective public health interventions, preventing millions of deaths each year. However, because vaccines are administered to large and often healthy populations, their safety is subject to intense scrutiny. Vaccine safety surveillance and pharmacovigilance systems are designed to detect, assess, and communicate risks in a transparent manner, thereby maintaining public confidence
In pharmacovigilance, safety data is meaningful only when it is systematically classified, coded, and interpreted. Drug and disease classification systems, standardized dictionaries, and structured information resources allow regulators, healthcare professionals, and pharmaceutical companies to communicate clearly and detect safety signals efficiently. Alongside these technical frameworks, the establishment of robust pharmacovigilance programmes at hospital, industry, and
Pharmacovigilance has become a cornerstone of modern healthcare systems, ensuring that medicines remain safe throughout their lifecycle. While clinical trials provide essential safety data before approval, real-world use often reveals rare or long-term adverse effects. Pharmacovigilance bridges this gap by continuously monitoring, assessing, and preventing adverse drug reactions (ADRs), thereby safeguarding public health on a
In the highly regulated pharmaceutical industry, success depends not only on scientific innovation but also on a clear understanding of regulatory concepts. Regulatory terminology, laws, guidance documents, and official reference publications form the backbone of how medicines are developed, approved, and monitored. For pharmacy students and regulatory professionals, mastering these concepts is essential to navigate
Clinical trials represent the most critical phase of drug development, where experimental medicines are tested in humans to establish safety, efficacy, and therapeutic value. Governed by strict ethical and scientific standards, clinical trials ensure that patient welfare remains central while generating reliable data for regulatory approval. From protocol development and ethics committee oversight to pharmacovigilance
