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

Author(s): Mohit , Aakash Deep* , Gaurav Khurana , Jagdeep Kumar , Akshay Monga .

Journal Name: Applied Clinical Research, Clinical Trials and Regulatory Affairs

Volume 6 , Issue 1 , 2019

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Graphical Abstract:


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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Article Details

VOLUME: 6
ISSUE: 1
Year: 2019
Page: [62 - 70]
Pages: 9
DOI: 10.2174/2213476X06666190128145525

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