The Great Green North: A Discussion on Canada’s Environmental Regulations
As we previously reported, agile licensing amendments to the Food and Drug Regulations and Medical Devices Regulations were registered on November 29, 2024. We are continuing to update our previous article to reflect new...more
Health Canada recently announced that it is exploring a regulatory pathway that would allow products containing cannabidiol (“CBD”) to be purchased without a prescription. Under the current regulatory scheme, all health...more
This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape. Jim Jones, Deputy Commissioner for Human Foods at the US Food and Drug...more
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
On February 5, 2025 Valneva SE (“Valneva”) announced that the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorization for Valneva’s chikungunya vaccine, IXCHIQ. ...more
On December 28, 2024, Health Canada published proposed amendments to the Food and Drug Regulations and Medical Devices Regulations to address therapeutic product shortages (see our previous article regarding Health Canada’s...more
Health Canada is proposing to amend the Food and Drug Regulations, C.R.C., c.870 (the FDRs) and the Medical Device Regulations, SOR/98-282 (the MDRs) in an effort to avoid pharmaceutical and medical device shortages and...more
On December 28, 2024, Health Canada published a regulatory proposal in the Canada Gazette, Part I, Volume 158, Number 52, introducing amendments to the Food and Drug Regulations, CRC, c 870 and the Medical Devices...more
On November 20, 2024, Health Canada posted Drug shortages in Canada: Fiscal year 2023 to 2024 in review. The review includes an overview of drug shortages, how Health Canada addresses shortages and the number of drug...more
On November 20, 2024, the Federal Court dismissed EMD Serono (Serono)’s judicial review of the Minister of Health’s decision to list Canadian Patent No. 3,087,419 (419 Patent) on the Patent Register one week after it was...more
Health Canada is making changes (via legislative amendments) to the manner in which medical devices and pharmaceutical products are recalled under the Medical Device Regulations, SOR/98-282 (MDR) and the Food and Drug...more
On October 10, 2024, Canada’s Bill C-64, An Act respecting pharmacare (the “Pharmacare Act”) received Royal Assent. This legislation establishes a framework for a national universal pharmacare system, aiming to enhance the...more
Changes affecting the approval of medical devices in Canada are coming. Health Canada has released a notice on Proposed Changes to the Guidance on Recognized Standards for Medical Devices along with a Draft List of Recognized...more
Draft Guidance and a Draft Section 66 Agreement Regarding Data Compensation in the Context of Re-Evaluations and Special Reviews - On September 10, 2024, Health Canada's Pest Management Regulatory Authority (PMRA)...more
As noted in our Field Notes blog of earlier this year, the Pest Management Regulatory Agency (PMRA) has now published the draft regulations amending the Pest Control Products Regulations (Strengthening the Regulation of Pest...more
In the first half of 2024, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. The Rx IP Update team at Smart & Biggar has collected the top stories from January to June and...more
On April 5, 2024, the pan-Canadian Pharmaceutical Alliance (pCPA) announced that it was ready to accept drugs through the pCPA Temporary Access Process (pTAP) (see our previous article regarding the consultation)....more
On February 23, 2024, Health Canada announced that it will expand the information available on the Generic Submissions Under Review (GSUR) list to include the following...more
On May 26, 2023, the Minister of Health determined that Biosimilar Collaborations Ireland Limited was entitled to the benefit of section 5 of the Patented Medicines (Notice of Compliance) Regulations (Regulations), including...more
For the first time, FDA approved a proposal that allows for the importation of Canadian-approved pharmaceuticals into the U.S., the first program of its kind to allow a state’s importation of pharmaceuticals approved by a...more
On January 5, 2024 the Food and Drug Administration (FDA) issued its approval of the State of Florida’s proposal to import certain prescription drugs from Canada under the Section 804 Importation Program (SIP). This approval...more
For folks who can’t wait for Christmas, when to put up their tree can be a dilemma. Should they wait until after Thanksgiving? December 1? Or throw all caution to the wind and put up their decorations as soon as the last...more
On November 1, 2023, the Federal Court of Appeal (FCA) dismissed Actial’s appeal from an application for judicial review of the Minister of Health’s decision to disclose records pursuant to a request under the Access to...more
Medical Devices Directorate Performance Annual Report - In September 2023, Health Canada published the Medical Devices Directorate Performance Annual Report for April 1, 2022, through March 31, 2023. The report provides...more
On October 25, 2023, the Patented Medicine Prices Review Board (PMPRB) announced that it will launch the first phase of consultations on new guidelines. The first phase will include a policy roundtable with stakeholders on...more