Source: https://invivo.pharmaintelligence.informa.com/SC073881/Asia-Raises-Bar-for-New-Drugs-Manufacturers-With-Tougher-CMC-Reviews-GMP-Inspections-Part-1
Timestamp: 2020-03-30 20:50:03
Document Index: 183040068

Matched Legal Cases: ['art 1', 'art 1', 'art 6', 'art 4', 'art 3', 'art 2', 'art 1']

Asia Raises Bar for New Drugs, Manufacturers With Tougher CMC Reviews, GMP Inspections (Part 1) :: In Vivo
Asia Raises Bar for New Drugs, Manufacturers With Tougher CMC Reviews, GMP Inspections (Part 1)
As Asian drug regulatory authorities gain confidence in their ability to regulate new drug products, they are subjecting applicants to increasingly extensive chemistry, manufacturing and controls reviews, more like those of first-tier authorities in the U.S. and Europe
Common Language For Regulatory Harmonization Takes Shape In Asia, But Mutual Recognition Unlikely Anytime Soon
Regulators, industry and health care agencies are increasingly using the same language to describe efforts at harmonization for drug approvals and manufacturing. But even though mutual recognition agreements on drug approvals are the “ultimate goal,” getting there in Asia could take a decade or more.
Japan Rolls Out GMP Revisions For PIC/S Compliance, But Integration Questions Linger
Japan’s PMDA moved swiftly to attach PIC/S guidance to existing guidelines. The agency is still working to integrate domestic GMP with international guidelines.
Asia Raises Bar for New Drugs, Manufacturers With Tougher CMC Reviews, GMP Inspections: A Look At India (Part 6)
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
Asia Raises Bar for New Drugs, Manufacturers With Tougher CMC Reviews, GMP Inspections - A Look At China (Part 4)
Asia Raises Bar for New Drugs, Manufacturers With Tougher CMC Reviews, GMP Inspections - A Look At Korea (Part 3)
Asia Raises Bar for New Drugs, Manufacturers With Tougher CMC Reviews, GMP Inspections - A Look At Taiwan (Part 2)
‘Global Allegiance’ of Inspectorates Emerging
ASEAN Makes Slow But Steady Progress Toward Harmonization Of Pharmaceutical Regulations
ASEAN Signs MRA To Ensure All Exports Meet GMP Standards In Southeast Asia By 2011
SC073881
Subject: Asia Raises Bar for New Drugs, Manufacturers With Tougher CMC Reviews, GMP Inspections (Part 1)