ABSTRACT
Research and development based on bio-genomic technologies have been developed recently in pharmaceutical sector. New types of product have come out, applying various state of art industrial and scientific technology in medical devices sector. International harmonisation will be more emphasised while information technology (IT) development enhances further international expansion of our daily life and industrial activities as well as governmental administration.<br>Thorough revision of Pharmaceutical Affairs Lan has been requested since it experienced several minor revisions throughout the time from the time of the first enforcement. The present major revision plan under preparation will provide three major items: safety measure of medical devices, comprehensive measures for biological products and revision of approval system in response to the needs of the 21st century.