Japan has the second largest individual market in the world. Japan market generates about 67% of the Asia - pacific market. Total market value in 2005 was $65.5billion USD. Unlike rest of the countries Japan has few barriers to consider like ICH does not cover all of Japan drug development, language barrier, J-GCP is followed here leading to many operational differences and barriers. The procedures followed in USA & EUROPE countries do not work here. This project is intended to describe the necessary regulatory hurdles and regulations required that are need before one can introduce a pharmaceutical product into Japan market.