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Canada Prescription Drugs

Goodwin

Update on Recent International Biosimilar Approvals - September 2024

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Approval of Celltrion’s Ustekinumab Biosimilar in the EU:  On August 26, 2024, Celltrion announced that the European Commission (EC) granted approval for STEQEYMA, formerly known as CT-P43, a biosimilar of STELARA...more

Smart & Biggar

Manitoba last province to introduce Biosimilars Initiative, while Ontario adds four drugs to its Biosimilar Policy

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Manitoba has implemented a Biosimilars Initiative effective August 1, 2024. Manitoba is the last province in Canada to implement a biosimilar policy that requires patients receiving funding under the Manitoba Pharmacare...more

Stikeman Elliott LLP

Regulatory Amendments Impacting Drug and Medical Device Recalls Coming Into Force

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On December 17, 2024, recent amendments to the Food and Drug Regulations (FDR) and the Medical Devices Regulations (MDR) relating to the recall of drugs and medical devices will come into force....more

Smart & Biggar

CDA–AMC (formerly CADTH) announces several pilot projects, including Target Zero initiative

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CADTH is now known as Canada’s Drug Agency (CDA-AMC or CDA). Its mandate extends beyond CADTH’s mandate to include: improving the appropriate prescribing and use of medications; increasing pan-Canadian data collection and...more

Smart & Biggar

Launch of pCPA temporary access process

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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

Jones Day

Canadian Drug Importation May Undermine Intellectual Property Protection

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The Situation: Earlier this year, Florida became the first state to receive authorization for its Section 804 Importation Program ("SIP") from the U.S. Food and Drug Administration ("FDA"). This initial step toward the legal...more

Stikeman Elliott LLP

Palmer v. Teva Canada Ltd.: Court of Appeal Confirms No Compensation for Risk “In the Air”

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In Palmer v. Teva Canada Limited, the Ontario Court of Appeal upheld the lower court’s decision to deny certification of a proposed product liability class action seeking damages for the alleged increased risk of being...more

Arnall Golden Gregory LLP

What Lies Ahead, We Have No Way of Knowing: FDA Authorizes Florida’s Drug Importation Program

A recent development with the Food and Drug Administration made us think of a song lyric from Florida native and Rock and Roll Hall of Famer, Tom Petty, “What lies ahead, [we] have no way of knowing.” As a kick-off to 2024,...more

Manatt, Phelps & Phillips, LLP

FDA Approves Florida’s Application to Import Drugs from Canada

On January 5, 2024, the Food and Drug Administration (FDA) authorized the state of Florida’s proposal under the Section 804 Importation Program (SIP) for a period of two years. FDA’s action marks the first time a state drug...more

Smart & Biggar

U.S. FDA authorizes Florida plan to import drugs in bulk from Canada

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A proposed program by the state of Florida to import certain prescription drugs from Canada has received the approval of the United States Food and Drug Administration (FDA): FDA news release on January 5, 2024....more

Quarles & Brady LLP

FDA Approves Florida’s Section 804 Importation Program for Importation of Canadian Pharmaceuticals

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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

Cooley LLP

FDA Greenlights Florida’s Proposal for Importing Prescription Drugs From Canada

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On Friday, January 5, 2024, the US Food and Drug Administration (FDA) authorized the Section 804 Importation Program (SIP) proposal of Florida’s Agency for Health Care Administration (FAHCA). The SIP is a pathway that allows...more

Foley & Lardner LLP

FDA: Major Policy Shift Authorizes Florida’s Plan to Import Drugs from Canada

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On Friday, January 5, 2024, in a major policy shift, the U.S. Food & Drug Administration (FDA) authorized Florida’s Agency for Health Care Administration’s plan to purchase medicines in bulk for its Medicaid programs,...more

Hogan Lovells

Florida still has a long way to go before it can begin importing certain Canadian drugs

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On January 5, 2024, the U.S. Food and Drug Administration (FDA) authorized Florida’s proposal under the Section 804 Importation Program (SIP) to allow Florida to proceed to the next steps in the regulatory process to import...more

BakerHostetler

FDA Authorizes Florida’s Drug Importation Program

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On Jan. 5, the FDA authorized Florida’s Section 804 Implementation program (SIP), making Florida the first state to secure such approval. Generally, there are three pathways to importing a prescription drug into the United...more

Smart & Biggar

Ontario Ministry of Health proposes regulatory amendments removing submission requirements for well-established drugs

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On October 19, 2023, the Ontario Ministry of Health proposed regulatory amendments under the Ontario Drug Benefit Act (ODBA) and the Drug Interchangeability and Dispensing Fee Act (DIDFA) to align Ontario’s requirements for...more

Smart & Biggar

PMPRB publishes scoping paper for consultation on guidelines, and invites stakeholder feedback

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As we have previously reported, the Patented Medicine Prices Review Board (PMPRB) announced that it will launch the first phase of consultations on new guidelines. On November 10, 2023, the PMPRB published its Scoping Paper...more

Smart & Biggar

CADTH time-limited recommendation category to enhance earlier access to promising new drugs

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On September 28, 2023, the Canadian Agency for Drugs and Technologies in Health (CADTH) introduced the time-limited reimbursement recommendation category, which aims to provide early access to promising new drugs that target...more

Smart & Biggar

Office of Parliamentary Budget Officer reports on Pharmacare cost estimate

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In June 2019, the Minister of Health tabled a report, A Prescription for Canada: Achieving Pharmacare for All, recommending that Canada implement universal, single-payer, public pharmacare (Pharmacare). On October 12, 2023,...more

Smart & Biggar

Developments in time-limited pharmaceutical market access: pCPA Temporary Access Process

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As previously reported, in the spring, the Canadian Agency for Drugs and Technologies in Health (CADTH) consulted on a process for time-limited reimbursement recommendations. The pan-Canadian Pharmaceutical Alliance (pCPA)...more

Smart & Biggar

Minister of Health releases statement on drug and other health product shortages

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On June 5, 2023, the Minister of Health released a statement on drug and other health product shortages, providing an update on actions being taken aimed at minimizing shortages and their impacts. ...more

Bennett Jones LLP

The Lack of Present Injuries and Reliable Scientific Evidence Proves Fatal in North American Pharmaceutical

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After reports were made regarding the presence of nitrosamines in certain pharmaceutical products in 2018 and 2019, and subsequent precautionary regulatory action was taken, an avalanche of litigation commenced in Canada and...more

Smart & Biggar

Certificates of Supplementary Protection (CSP)

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On May 12, 2023, Health Canada announced the fifth version of the Guidance Document: Certificates of Supplementary Protection. The changes are described as being made to reflect current administrative practices, and to...more

Smart & Biggar

Health Canada proposes amendments to the Food and Drug Regulations and Medical Devices Regulations to modernize framework for...

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On April 15, 2023, Health Canada proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations (together, the “Proposed Amendments”). The Proposed Amendments are intended to modernize the frameworks...more

Smart & Biggar

CADTH consultation on time-limited reimbursement initiative, and IMC report on what Canada can learn from Europe

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The Canadian Agency for Drugs and Technologies in Health (CADTH) has released a consultation document for a Proposed Process for Time-limited Reimbursement Recommendations. The time-limited reimbursement recommendations would...more

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