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On June 27, 2019, Health Canada published Drug and medical device highlights 2018: Helping you maintain and improve your health, an annual highlights report for 2018.

These changes are summarized in CDR Update – Issue 138, and will be enforced for all submissions and resubmissions received on or after July 27, 2018.

We reported on the six Federal Court and three FCA PMNOC Regulations decisions publicly released in 2017.

In view of the ongoing COVID-19 disruption, the Canadian Intellectual Property Office (CIPO) has further extended patent, trademark, and industrial design deadlines fixed under the relevant legislation.

On December 7, 2017, the Federal Court of Appeal upheld Justice Simpson's decision to strike Alexion's pleadings challenging the constitutionality of the PMPRB regime:

On December 10, 2019, the parties to the Canada-United States-Mexico Agreement (commonly referred to as USMCA, or the new NAFTA) signed amendments to the Agreement.

As previously reported, on July 12, 2018, Health Canada had published "Guidance on Notifying Health Canada of Foreign Actions – Guidance Document for Industry".

On June 12, the Advisory Council on the Implementation of National Pharmacare released its final report which recommends that Canada implement a universa

While originally proposed to come into force on January 1, 2019, sweeping amendments to the Patented Medicines Regulations governing pricing criteria were still not released as of June 30

On June 10, 2019, the Regulations Amending the Food and Drug Regulations (Serious Adverse Drug Reaction Reporting – Hospitals)and Regulations Amending the Medical Devices Regulations

On June 30, the Supreme Court of Canada (SCC) delivered its highly anticipated decision, AstraZeneca v Apotex, 2017 SCC 36 relating to esomeprazole (NEXIUM).

As of June 30, Health Canada had approved 16 biosimilars, based on 11 comparator products (3 in 2019).

Apotex was unsuccessful in three Health Canada court challenges.

Participants can provide their feedback online until September 28, 2018 or in writing to the Council.

Patented Medicine Prices Review Board's multi-stakeholder Steering Committee holds first meeting

Separately, in Ontario, on December 12, Bill 160, the Strengthening Quality and Accountability for Patients Act, 2017, received Royal Assent.

As reported previously, the Federal Court issued an interlocutory injunction on June 1, 2016 directed at retailers of set-top boxes that are configured, or "pre-loaded", with various applications that provide their users with unauthorized access to copyrighted television content.

According to the notice, these aligned reviews are expected to reduce duplication and time lags between Health Canada market authorization and HTA recommendations.