Abstract

REGULATORY REQUIREMENTS FOR THE REGISTRATION OF PHARMACEUTICAL PRODUCTS IN MALAYSIA

Kritika Rai and Dr. Nutan Rao*

Abstract

This study aim is to analyze the ASEAN pharmaceutical regulatory landscape in terms of the ease of doing business, the impact of Harmonization, and the key factors and dynamics influencing member countries and the outside world. It provides strategic recommendations for market participants and conclusions. Drug 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 filing, yet others have great size diversity in requirements. ICH brought regulatory authorities and pharmaceutical industries of Europe, Japan and US together for numerous aspects of drug registration. Similarly, countries from Asia pacific are in process of harmonization with mutual concern as The Association of Southeast Asian Nations (ASEAN). The optimization in requirements is compulsory and can be judged by the incidence of higher cost involved in availability of drugs, research and development facilities. For better treatment efficacy and safety for the drugs must be rationalize and justified for public security. The quality, safety and efficacy data have its own importance in the registration dossier. The commercial significance of markets is increasing globally. It is essential for pharmaceutical industry to cope with the regulatory requirements for betterment of public and to ensure their place in the market. This Thesis lines 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 in Malaysia (ASEAN Country).

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