A year in review of Health Canada’s Access to Information matters
On November 7, 2023, Health Canada released its annual report on the Access to Information Act and Privacy Act, reporting on the...Read More
To Market, To Market, or the Regulations Will Not Apply
The Federal Court dismissed two applications for judicial review by AbbVie Corporation, who challenged the Minister of Health’s decisions (1) finding JAMP...Read More
Supreme Court of Canada agrees to hear Ontario private label drug appeal
On August 30, 2012, the Supreme Court of Canada granted leave to appeal in Katz Group Canada Inc. v. Minister of Health and...Read More
FDA’s biosimilar stakeholder submission roundup – Part III
In March 2010, the Biologics Price Competition and Innovation Act of 2009 (BPCIA) became law and established a legal pathway for the...Read More
FDA’s biosimilar stakeholder submission roundup – Part II
In March 2010, the Biologics Price Competition and Innovation Act of 2009 (BPCIA) became law and established a legal pathway for the...Read More
FDA’s biosimilar stakeholder submission roundup – Part I
In March 2010, the Biologics Price Competition and Innovation Act of 2009 (BPCIA) became law and established a legal pathway for the...Read More
PM(NOC) guidance document updated to address cross-referenced drug submissions
On April 2, 2012, Health Canada issued an updated guidance document on the Patented Medicines (Notice of Compliance) Regulations. In particular, section...Read More
EMA publishes new procedural advice document for biosimilar applicants
The European Medicines Agency (EMA) has published a new document providing procedural advice for users of the centralised procedure for biosimilar product...Read More