Abstract

A COMPREHENSIVE REVIEW ON DRUG REGULATORY GUIDELINES IN MIDDLE EAST AND THE NORTH AFRICAN COUNTRIES

Ramana Kumari Avirneni*, Prakash Nathaniel Kumar Sarella

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Abstract

The Middle East and North Africa (MENA) region presents a mix of opportunities and obstacles for drug companies seeking to register their products. Despite economic growth and a large population, navigating regulatory requirements and political complexities proves challenging but critical for accessing this important market. This analysis aims to evaluate registration procedures for pharmaceuticals in MENA countries, understand their constraints and potential, and provide insights for companies. While the drug market shows diversity, sustainability, and expansion driven by population size, oil wealth, higher incomes, education, a larger middle class, and disease burden, regulations and uncertainties curb progress. Regulatory bodies administer separate healthcare systems, but written laws are limited, mostly in local languages, open to interpretation, and hindered by lack of transparency or instability in some countries. Demand for advanced drugs and medical goods will likely increase, but navigating complex regulations and requirements presents difficulties. Each country issues guidelines for health authorities and export/import medication. Requirements encompass export applications, checklists, renewal registrations, lab standards, supplement registrations, application receipts, and appointment sheets. Public health services are managed differently, requiring country-specific knowledge. Opportunities abound for addressing health needs, but political and economic realities significantly impact regulations and companies’ ability to access this market. Improving standards are dampened by ongoing challenges. MENA remains an important yet complicated market for pharma companies to understand for registration and entry.

Keywords: Regulations guidelines, MENA countries, Market access, Regulatory constraints, Common technical document.