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Health Canada Releases New Biosimilar Biologic Drugs Guidance Document

Health Canada has recently released the revised Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs (the “Guidance Document”), replacing the March 2010 Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics. The Guidance Document is meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations, but does not have the force of law. The Guidance Document is one of the primary resources provided by Health Canada regarding approval of biosimilars.

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One Step Closer to Legalization of Marijuana in Canada: Release of Task Force Recommendations for Regulation of Cannabis

The Task Force on Cannabis Legalization and Regulation publicly released its report today outlining its recommendations on the Legalization and Regulation of Cannabis in Canada. 

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Deciphering the Term Sheet: Valuation

This article is the first in a series of articles that will delve into the most important terms in investment Term Sheets for early-stage companies.

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Tips for First-Time Investment Fundraisers

The first time a venture seeks external fundraising, often from an angel investor or venture capital firm, is a major milestone. The following suggests some tactical tools for reaching out to, and getting the attention and interest of, these investors:

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Canada Introduces Vaping Legislation

On November 22nd, new legislation was introduced (Bill S-5) that proposes significant changes to the Tobacco Act to institute regulation of vaping products and implement other changes to the regulation of tobacco products.

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New US$500 Million Global Life Sciences Venture Fund Launched

Quark Venture Inc., a Canadian based venture firm, and GF Securities Company Limited, a China based investment bank, have recently launched a US$500 million life sciences venture capital fund. The fund will be based out of Vancouver, and is expected to focus on building a diversified portfolio of innovative biotechnology, pharmaceutical, and life sciences companies. It is now the largest life science fund in Canada and has already committed US$100 million into various life sciences companies.

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Food For Thought: Changes Impacting the Content, Labelling and Marketing of Food Products in Canada Announced

Canada’s Minister of Health has announced the launch of a new Healthy Eating Strategy that will impact manufacturers, distributors and retailers of food products in Canada. This initiative proposes to implement changes to the way that foods are produced, labelled and marketed in an effort to address obesity, diabetes, heart disease and other chronic health conditions.

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Developing Toronto's Life Science and Healthcare Innovation Economy

The core theme of the 2016 World Economic Forum in Davos, Switzerland was the arrival of the Fourth Industrial Revolution, with its velocity, scope and disruptive impact on almost every industry of every country.1  Much of the change is attributable to the creation and duplication of the digital universe of data, believed to be expanding by 40% per year.2  One of the sectors which is expected to be radically altered, and benefit significantly, is life sciences, and particularly, healthcare.

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The Capital Landscape for Early-Stage Life Science Ventures

As an early-stage start-up, regardless of industry, understanding the players in the investment landscape is important. Over the past several years, the types of investors interested in early-stage life science ventures has diversified, with investors that would normally invest at later stages now often looking to fund companies at earlier stages of commercialization.1  The following is a cross-section of the key players.

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Sep 28, 2016
TAGS: Regulatory
A New Regulatory Regime For E-Cigarettes? Health Canada Announces Plans to Introduce Vaping Legislation

Yesterday, the federal government announced that it would be tabling legislation with respect to vaping products. Health Canada’s announcement in this regard can be found here.

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Sep 7, 2016
TAGS: Regulatory
Changes Could Be Coming in Canada’s Regulation of Self-Care Products: Your Chance to Weigh In!

Health Canada is undertaking a public consultation on its regulation of self-care products (non-prescription drugs, natural health products and cosmetics). This is part of a larger consultation on the Framework for Consumer Health Products, started in 2014.

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A Case that Could Determine the Future of Health Care in Canada

On September 6, 2016, the British Columbia Supreme Court began hearing a case (“Cambie”) that could have far-reaching effects on the face of health care in Canada.

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Amendment to PMPRB Compendium of Policies, Guidelines and Procedures Takes Effect

On September 1, 2016, the Patented Medicine Prices Review Board (the “PMPRB” or the “Board”), Canada’s independent quasi-judicial patented drug price watchdog, implemented an amendment (the “Amendment”) to section C.11 “Review of Prices of New Patented Drug Products at Introduction” of the Compendium of Policies, Guidelines and Procedures (the “Guidelines”)1. The Amendment brings an incremental but important change to the Guidelines, of which patentees in the pharmaceutical, biotechnology, and healthcare industries should be aware.

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Regulating Risk: Keeping You Up-To-Date on Product Regulation - September 2016

Here’s a look at what’s new with product regulation and oversight in Canada.

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The Ongoing Evolution of Canada’s Regulation of Marijuana

In the ongoing evolution of Canada’s marijuana laws, this summer, Health Canada implemented the new Access to Cannabis for Medical Purposes Regulations (“ACMPR”).  The ACMPR came into force on August 24, 2016 (replacing the old Marihuana for Medical Purposes Regulations) and provide increased access for Canadians who have been authorized by their healthcare practitioners to use cannabis for medical purposes.

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An Opportunity to Reshape Patented Medicines Regulation in Canada

The Patented Medicine Prices Review Board (the “PMPRB” or the “Board”) is currently canvassing stakeholder input on its Discussion Paper1 released on June 24, 2016, as part of an initiative to reform and modernize its regulatory framework.  

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Regulating Risk: Keeping You Up-To-Date on Product Regulation - May 2016

Here’s a look at what’s new with the Canada Consumer Product Safety Act and regulations to the Food and Drugs Act and Controlled Drugs and Substances Act.

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