Scrip is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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

Related Content

UsernamePublicRestriction

Register

OM002409

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Thank you for submitting your question. We will respond to you within 2 business days. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel