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

[ Vol. 6 , Issue. 1 ]

Author(s):

Mohit, Aakash Deep*, Gaurav Khurana, Jagdeep Kumar and Akshay Monga   Pages 62 - 70 ( 9 )

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.

Affiliation:

Department of Pharmaceutical Sciences, Chaudhary Bansi Lal University, Bhiwani 127021, Department of Pharmaceutical Sciences, Chaudhary Bansi Lal University, Bhiwani 127021, Rhydburg Pharmaceuticals Ltd., New Delhi-110009, Rhydburg Pharmaceuticals Ltd., New Delhi-110009, Rhydburg Pharmaceuticals Ltd., New Delhi-110009

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