Asia Raises Bar for New Drugs, Manufacturers With Tougher CMC Reviews, GMP Inspections: A Look At India (Part 6)
This article was originally published in PharmAsia News
Executive Summary
Like most other Asian nations, India will not consider an application for marketing approval of a drug unless it comes with a certificate of pharmaceutical product showing that a major market has already approved the product, said Mark Rosolowsky, executive director, GRS-CMC, Bristol-Myers Squibb
You may also be interested in...
Asia Raises Bar for New Drugs, Manufacturers With Tougher CMC Reviews, GMP Inspections: A Look At Japan (Part 5)
The one Asian country with "first-tier" status, Japan may be on a par with the U.S. and the EU in the International Conference on Harmonization, but the country nevertheless faces challenges in the CMC and GMP arenas, said Pramod Kotwal of Merck, Sharpe and Dohme
Asia Raises Bar for New Drugs, Manufacturers With Tougher CMC Reviews, GMP Inspections - A Look At China (Part 4)
China's pharmaceutical regulatory system is in flux as it grows with the emerging economic giant's rapidly expanding drug manufacturing sector
Asia Raises Bar for New Drugs, Manufacturers With Tougher CMC Reviews, GMP Inspections - A Look At Korea (Part 3)
South Korea's pharmaceutical regulatory program is in a state of change, and the Korea FDA is open to ongoing changes to support regulatory harmonization with the rest of the world. That openness presents an opportunity for industry to influence some differences between Korea and the rest of the world, according to said Jeffrey Ferguson, Eli Lilly's director of global regulatory affairs CMC