Regulatory Framework and Comparative Study of Post Approval Changes (Variation Filling) For Parenteral Drug Products in Asean and GCC Regions

Abstract

Change is everywhere and it is never ending. The pharmaceutical industries being a most regulated and stringent, even a smallest change is to be documented and reported to the all international and national regulatory agencies. This study gives the regulatory view on post approval changes / variation management of various semi-regulated regulatory authorities of Malaysia, Philippines, Saudi Arabia, and United Arab Emirates. The semi-regulated authorities are also becoming stringent with well-established guidelines for the different submissions. The authorities are also move towards the electronic submissions rather than traditional paper submission. Most of the ASEAN Countries follows the ASEAN variation guideline for pharmaceutical product, whereas some of the countries like Malaysia and Philippines has made some changes to these guidelines and came with a new version of their own. GCC countries refers to the European Medicines Agency’s Guidelines for their submissions. The GCC guidelines for variation requirements version 6 are referred by various countries of the region, but with reference to this guideline some of the countries like United Arab Emirates, Saudi Arabia, Qatar, etc. has also published their own guidelines. According to these all guidelines the various changes are classified differently in major, moderate, and minor changes. Some of the minor changes can be implemented after notifying the authorities about the change with relevant documents. Whereas in major, and some minor changes the prior approval of the authority is required. Some major changes cannot be considered as a major change, instead it shall be filled as a new registration or a new product. The project gives an idea about how the post approval change / variation can be documented and submitted to the agencies of Malaysia, Philippines, Saudi Arabia, and UAE. The case based hypothetical changes have been made and discussed in the thesis work.