Abstract
COMPARATIVE STUDY OF REGULATORY REQUIREMENTS FOR MULTISOURCE GENERIC DRUGS IN ASEAN COUNTRIES

Venu A. and Sandhyarani G.*

ABSTRACT

Regulatory Affairs department is growing within companies and is constantly evolving and growing and is the one which is least impacted during the Acquisition and Merger and also during recession. Global harmonization in standards has led to consistent approach in regulatory submissions and hence its review. Systematic formulation development acts as a back bone for any dossier preparation in export registration. There are different requirements in different countries for registration. It is difficult for any company to develop product for each region. Therefore, we need to consider majority of requirements during technical data submission which will help in export registration. Regions, but all are national registrations in these countries. Enormous diversity of regulatory requirements is there. However, harmonization occurs as clusters e.g. ASEAN, Gulf Council etc.

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