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Proposed Regulation › Reporting Requirements › Life Sciences

Blake, Cassels & Graydon LLP

Health Canada Proposes Regulations to Mitigate Drug and Medical Device Shortages

Blake, Cassels & Graydon LLP on

Health Canada recently published draft regulations to address therapeutic product shortages in Canada. The Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Shortages and Discontinuation of Sale of...more

Smart & Biggar

Health Canada’s proposed regulatory amendments to address health product shortages

Smart & Biggar on

On June 25, 2024, Health Canada published a notice of intent and Building resilience: Health Canada’s plan to address health product shortages, 2024 to 2028, relating to Health Canada’s plan over the next 4 years to address...more

King & Spalding

Europe - Between The EU Clinical Trials Regulation And The UK Guideline On Clinical Trials

King & Spalding on

Last week the Regulation on Clinical Trials (“CTR”) finally became effective in the European Union (“EU”) and replaced the prior Clinical Trials Directive 2001/20 (“CTD”). The CTR was adopted in 2014 and was meant to enter...more

Smart & Biggar

Canada releases proposed amendments to Regulations governing patented medicines pricing

Smart & Biggar on

On December 2, 2017 Canada’s Governor-in-Council published proposed Regulations Amending the Patented Medicines Regulations (“the proposed Regulations”). The 75-day consultation period ends February 15, 2018. The proposed...more

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