Tagged with Canada

Canada Dr David Reddy, Director General, IFPMA, and Dr Bettina Hamelin, President, IMC, jointly advocate for health innovation at the 2025 G7 Summit in Kananaskis (15-17 June). They call G7 leaders to place health and life-sciences innovation at the heart of the G7 agenda, emphasizing three areas of focus where the…

Japan After 12 years at the helm, Takeda CEO Christophe Weber is stepping down, leaving behind a transformed company. Under his leadership, Japan’s biggest drugmaker expanded globally with the $62 billion acquisition of Shire, made waves with its dengue vaccine QDENGA, navigated the loss of exclusivity on its ADHD blockbuster, and…

Switzerland Europe and Canada (EUCAN) have an essential role in Takeda’s global mission to advance healthcare innovation. Ricardo Marek, President of Takeda’s EUCAN division, discusses the operational and regulatory challenges, the importance of Switzerland as a strategic base, and Takeda’s post-Shire acquisition growth strategy.   Europe is central not just as…

Global AstraZeneca’s Anna Litsiou, Carolyn Hynes and Allison Guy, contributing to the September 2024 edition of DIA’s Global Forum magazine, discuss the importance of improving interactions between health technology assessment (HTA) bodies and regulatory authorities.   The need to optimize drug development and facilitate faster access for patients has focused discussions…

Global DIA’s Sorcha McCrohan, contributing to the the August 2024 edition of DIA’s Global Forum magazine, reviews insights from the town hall meetings that brought together regulators from around the world at the organization’s Global Annual Meeting 2024.   Regulators worldwide recently convened in San Diego for DIA’s Global Annual Meeting 2024 to…

Canada The biggest stories coming out of Canadian pharma and healthcare, including AstraZeneca’s acquistion of Canadian biotech Fusion Pharmaceuticals; Valeo Pharma’s new senior executive and board of directors, and generics maker Apotex’s bid for Searchlight Pharma.   Canada, UK launched joint probe into 23andMe data breach, says Canada (Reuters) The Canadian and…

Canada On March 29 2023, the Quebec Health Minister (the “Minister”) introduced Bill 15, an Act to make the health and social services system more effective (the “Bill”). The Bill, which is still at the detailed study stage, proposes a major renewal of the framework for the health and social services…

Canada Drs Neil Cashman and Larry Altstiel of ProMIS Neurosciences weigh in on recent progress towards an effective therapy for Alzheimer’s disease, potentially representing a break from three decades of scientific stagnation.   Are we there yet with Alzheimer’s immunotherapies? No. But we have a map, and it’s a good one.…

Pharma Legal Handbook 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Health Canada is the federal authority responsible for regulating pharmaceutical drugs, biologicals, and medical devices for human use. Health Canada’s Health Products and Food Branch (“HPFB”) is the body responsible for reviewing, assessing,…

Pharma Legal Handbook 16. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? There is no requirement to conduct local trials of a new drug to receive marketing approval. Rather, in order to obtain marketing approval, a company must submit an NDS application containing information…

Pharma Legal Handbook 22. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? The authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products are mentioned in Chapter 1, Question 3: What are the steps…

Pharma Legal Handbook 44. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? In Canada, traditional, herbal, complementary or alternative medicines are included under the previously defined term “NHPs.” NHPs are governed by the Food and Drugs Act and the Natural Health Products Regulations, which provide requirements concerning…