Tuesday, December 21, 2004

Canada revisits pharmaceutical regulation

On December 11, the Canadian government proposed amendements to its Patented Medicines (Notice of Compliance) Regulation and its Food and Drug Regulations.  The first is similar to the US' Hatch-Waxman Act; the second to the US' FDA regulations. 

The amendments to the Patented Medicines Regulation make it easier to bring generic drugs to market by limiting when patent infringement claims can be brought by potential generic drug manufacturers.  Under current law, the generic drug maker has the burden to challenge the patent or wait for the patent to expire.  Under the proposed amendments, only patents that have claims for the medicines or its use and patents that have application filing dates before the generic submission can be listed in Canada's equivalent of the Orange Book. For more details, follow this link.

The proposed amendments to its Food and Drug Regulations provide protection against unfair commercial use of undisclosed test data or other materials submitted for approval.  The amendments are designed to bring Canada in compliance with obligations under NAFTA and TRIPS regarding new chemical entities.  For more details, follow this link.


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