Registration Requirements and Comparative Study of Genetic Drug Registration Between MENA and ASEAN Countries

Abstract

MENA region involves Middle East countries Bahrain, Kuwait, Iraq, Qatar, Saudi Arabia, UAE. The MENA pharmaceutical market has recorded significant growth in the past few years, as a result of increased spending power, growth of aging population, and lifestyle associated diseases. Eventually, the total demand for pharmaceutical products has reached the highest levels in some of the MENA countries, and the pharmaceutical products sales are expected to grow massively in the upcoming years. Hence, many governments in the region have started encouraging more investments in the local pharmaceutical manufacturing, either through building new pharmaceutical industrial areas, or through attracting more foreign direct investment. Asia is world’s largest and most populated continent having huge diversity in culture, climate, and government system. Nowadays Asian countries are progressively tightening their healthcare regulation standards. For the successful drug registration in Asia region, local knowledge of healthcare regulations plays vital role for improving the speed, cost and efficiency of introducing new medicines into these markets, thereby allowing timely access to patients. In proposed project work explanation of various regulatory authorities of different countries of MENA (UAE, Kuwait, Iraq) and ASEAN (Vietnam, Thailand, Malaysia) region by describing their document requirements, approval procedure, evaluation time period, fees, renewal guidelines. And the registration requirements for generic drug product is compared between MENA and ASEAN region.