How the Rest of the World’s Capacity-Building Impacts the Global Regulatory Dossier
This article was originally published in The Gold Sheet
Executive Summary
Emerging nations are supplanting the developed world’s vision of global pharmaceutical regulatory harmonization with one of their own: capacity-building and convergence. A main point of focus will be creating the regulatory review and manufacturing capability needed to launch biosimilars in countries like Brazil and Taiwan.
You may also be interested in...
‘Shadow’ Factory Challenges Continue For US FDA
Agency wants more information about API suppliers as it winds up case against KV Tech for hidden use of Dr. Reddy’s plant and seeks to find disappearing manufacturer of contaminated OTC eye drops.
US FDA, USP Raise Questions About Valisure’s Assertions Of Benzoyl Peroxide’s Benzene Risks
The US drug regulatory authority and standard-setting organization are evaluating the drug-screening venture’s findings regarding stability and potential carcinogenic risks associated with the widely used acne treatment, which includes Rx formulations.
US FDA Seeks More Power To Confront ‘Shadow’ Factory Challenges
Agency wants more information about API suppliers as it winds up case against KV Tech for hidden use of Dr. Reddy’s plant and seeks to find manufacturer of contaminated eye drops that disappeared.