May 07, 2012
Health Canada faces streamlined regulatory responsibilities for Rx-to-OTC drug switches and natural health products under federal government plans to slash the agency’s budget and staff. The change is likely a boon to US sponsors seeking Canadian approval for OTC switches.
The Canadian health authority announced April 26 the government’s budget legislation - Economic Action Plan 2012 - calls for eliminating Schedule F of the Food and Drug Regulations, which HC says will reduce the red tape that typically holds up Rx-to-OTC switches 14 to 20months.
Teresa Reguly said the disposal of Schedule F will benefit U.S. drug marketers seeking OTC status for their products in Canada - especially when those products have long since switched in the US.
“I think this does resent an opportunity for companies that are looking to get their products more easily to consumers more quickly," said Teresa.
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