Industry Reacts to Tough Excipient Regulations in China and Brazil
This article was originally published in PharmAsia News
China is imposing tougher – and in some cases unrealistic – requirements for excipient manufacturers, while Brazil is proposing similar new requirements. Confusion abounds with respect to shelf life, expiration dates and retest dates.
You may also be interested in...
Brazil’s ANVISA shows global leadership in regulating pharmaceutical excipients with proposed excipient GMPs. Comments were generally favorable, though there were concerns about the extent of applicability to foreign excipient makers.
The US FDA tells manufacturers in two recent warning letters to get to the root cause of contamination problems and take a more proactive approach to cleaning and equipment maintenance.
Commissioner Hahn’s tweet announcing a return to inspections, while not a new policy, may be signal that FDA understands sponsor concerns with the agency’s limited ability to conduct onsite inspections. Effort may be aimed at reassuring industry even as CRLs related to manufacturing increase.