Navigating Global Regulatory Divergence in Over-the-counter Drugs: Addressing Emerging Risks and Harmonization Challenges.

The worldwide market for over-the-counter (OTC) medications is quickly developing, providing consumers with increased self-medication options while facing substantial regulatory issues due to varied approval procedures, labeling regulations, and safety standards between nations. Despite efforts to standardize regulatory frameworks, differences in component classification, dosage limitations, and risk assessment standards impede producers, healthcare professionals, and lawmakers. This analysis looks at the regulatory environment of over-thecounter pharmaceuticals in major countries, including the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA), and regulatory organizations in Asia- Pacific and developing economies, highlighting notable disparities in approval procedures, marketing authorization, and pharmacovigilance.