Comparison of Regulatory Requirements for Registration of Pharmaceutical Drugs in Asean and GCC Regions

Mohit; Aakash       Deep; Gaurav       Khurana; Jagdeep       Kumar; Akshay       Monga

Abstract

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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DOI https://dx.doi.org/10.2174/2213476X06666190128145525	Print ISSN 2213-476X
Publisher Name Bentham Science Publisher	Online ISSN 2213-4778

Applied Clinical Research, Clinical Trials and Regulatory Affairs

Comparison of Regulatory Requirements for Registration of Pharmaceutical Drugs in Asean and GCC Regions

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