Health Canada is telling drug and API manufacturers that it’s going to ramp up announced and unannounced inspections due to concerns raised around APIs and data integrity, and the findings will be published online beginning next month.
Bacterial contamination issues at a GlaxoSmithKline flu vaccine production plant are now being dealt with by an action plan that Health Canada has approved.
Looking to align with other industrialized nations, Canada has agreed to extend its GMP requirements for all active pharmaceutical ingredients (APIs), according to a notice in the Canada Gazette.
Health Canada says moving to an electronic filing system for regulatory submissions will reduce costs but warned drugmakers not to include their credit card details.
Since the publication of this article, in-PharmaTechnologist.com has been in touch with Health Canada to find out that the "updates" to the guidance document were actually to the font, not to the regulations. Health Canada launched no disclaimer...
Health Canada officials are working “around the clock” to approve 23 new drug applications in one month to combat national meds shortages caused by troubles at Sandoz.
Drug regulator Health Canada has published its draft guidelines for
pharmaceutical firms seeking to gain approval for biosimilars or
"subsequent entry biologics."
