OVERVIEW OF DRUG REGISTRATION REQUIREMENTS FOR PHARMACEUTICALS IN EMERGING MARKET

摘要

Pharmaceutical product registration is a demanding task in regulated, semi regulated and rest of world countries. Although the requirements are harmonized in regulated countries by CTD (Common technical document) filing, yet others have enormous diversity in requirements.ICH (International conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) brought regulatory authorities and pharmaceutical industries of Europe, Japan and US together for various aspects of drug registration. Similarly, countries from Asia pacific and gulf are in process of harmonization with mutual concern as The Association of Southeast Asian Nations (ASEAN) and Gulf Co-operation Council (GCC). The optimization in requirements is mandatory and can be judged by the incidence of higher cost involved in availability of drugs, research and development facilities. For better treatment safety and efficacy for the drugs must be justified and rationalize for public security. The quality, safety and efficacy data has its own importance in the registration dossier. The commercial significance of markets is increasing globally. It is vital for pharmaceutical industry to cope with the regulatory requirements for betterment of public and to ensure their place in the market. This paper approaches the registration requirements in the form a dossier for market authorization. It also has drawn a comparative statement on various approaches for harmonization of registration requirement for pharmaceuticals.