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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 61 - 69 ( 9 )

Abstract:


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. 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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