ISSN
2249-7633
e ISSN
2249-7625
Publisher
Pharmacy Practice & Drug Research
DRUG REGULATIONS AND REGISTRATION IN JAPAN
Author / Afflication
Gowthami V
Krishna Teja Pharmacy College, Chadalawada Nagar, Tirupathi-517506, Andhra Pradesh, India
Lokesh Reddy M
Krishna Teja Pharmacy College, Chadalawada Nagar, Tirupathi-517506, Andhra Pradesh, India
Sabareesh Reddy M
Krishna Teja Pharmacy College, Chadalawada Nagar, Tirupathi-517506, Andhra Pradesh, India
Alagu Sundaram M
Krishna Teja Pharmacy College, Chadalawada Nagar, Tirupathi-517506, Andhra Pradesh, India
Jayachandra Reddy P
Krishna Teja Pharmacy College, Chadalawada Nagar, Tirupathi-517506, Andhra Pradesh, India
Keywords
ICH , J – GCP ,WHO ,MAA ,
Abstract
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.
Volume / Issue / Year
4 , 3 , 2014
Starting Page No / Endling Page No
149 - 161