Background: The product registration in rest of the world is a challenging task because
they are not harmonized. ASEAN and GCC regions come under semi-regulated market. These regions
have somewhat harmonized their regulatory organization. The significance of an emerging
market is increasing globally. It is important for pharmaceutical companies to be up-to-date with
the latest regulatory development. ASEAN used ACTD format and GCC used ICH CTD format
for drug product Registration. ASEAN includes a group of countries like Singapore, Philippines
etc. Whereas GCC includes Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and UAE.
Conclusion: This review article focuses on general regulatory requirements of registration of
pharmaceuticals in ASEAN and GCC region.
Keywords: Regulation, ASEAN, GCC, pharmaceutical companies, drugs, guidelines.
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