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    Health Canada Seeks to Update User Fees for Drug and Device Firms

    Health Canada this week opened for consultation a proposal to update and increase some of the fees it assesses for pharmaceutical and medical device companies, noting that the last update came in 2011 and was based on 2007 data. In addition to increasing some fees significantly (see more below on some of the changes), the proposal would also give new authority to Health Canada to withdraw or withhold service or approval if a fee is not paid, and all fees moving fo...
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    Canada Reimbursement Profile

    This profile summarizes reimbursement processes in Canada, presents information for key stakeholders and highlights what should be considered early in the development process. Obtaining regulatory approval for medicines is the first major hurdle of most pharmaceutical and biotechnology companies looking to launch their products worldwide. However, obtaining market access once products are approved by regulatory agencies (e.g., Health Canada) is a separate and crucial p...
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    Health Canada Opens Consultation on Mandatory Adverse Drug Reaction, Device Incident Reports

    Health Canada on Tuesday opened up a consultation on changes to the country's Food and Drug Regulations and Medical Devices Regulations that would make it mandatory for certain health care institutions to report serious adverse drug reactions (ADRs) and medical device incidents (MDIs). "Reports about serious ADRs and MDIs can be important signals of emerging safety issues. Such post-market observations can also lead to improved safety information about a product," ...
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    Canada Proposes to Amend Drug Pricing Regulations

    For the first time in more than two decades, Canada’s government is looking to amend its drug pricing regulations to better protect Canadians from paying excessive prices for patented drugs. The move comes as the US government is undergoing a similar review of ways to bring down the price of drugs in the US, though one major difference between the neighbors is that Canada’s government has a means by which it can control the price of medicines. The US Congress is als...
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    Democrats Revive Canada Drug Import Bill as Safety Questions Linger

    Sens. Bernie Sanders (D-VT) and several colleagues who previously opposed such a measure, Cory Booker (D-NJ), Bob Casey (D-PA), Martin Heinrich (D-NM), Angus King (I-ME), alongside Reps. Elijah Cummings (D-MD) and Lloyd Doggett (D-TX) on Tuesday revived legislation lingering for more than a decade to allow the importation of medicines from Canada and other countries to help lower US drug prices. Sanders called the bill "critical" on Tuesday at a press conference, saying...
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    Senators Call on HHS to Allow Canadian Drug Imports if Prices Spike

    Sens. Charles Grassley (R-IA), John McCain (R-AZ) and Amy Klobuchar (D-MN) on Tuesday sent a letter to Tom Price, the newly confirmed secretary of the Department of Health and Human Services (HHS), calling on him to fast-track the approval of prescription drugs imported from Canada in four different circumstances, including if the price of a drug increases significantly. Those circumstances are: If a drug is off patent or no longer marketed in the US by the innovato...
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    Health Canada Looks to Raise the Bar for Regulating Natural Health Products

    A controversial new proposal from Health Canada would add new regulatory scrutiny for natural health products and bring them in line with higher scientific standards used to regulate over-the-counter drugs. The proposal, unveiled in late September, would cover the three buckets of health products and group them together as part of new regulations for “self-care products,” which is part of the regulator’s wider effort to refocus the approval of health claims based on sc...
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    Health Canada Updates Bioavailability Requirements for Highly Variable Drugs

    Health Canada on Monday unveiled new comparative bioavailability requirements for drugs exhibiting large pharmacokinetic within-subject variation in terms of absorption. Although highly variable drugs are generally safe, the Canadian regulator says, the bioequivalence of their formulations is a problem because high variability means that large numbers of subjects are required to give adequate statistical power. In addition, highly variable drugs are poor quality formul...
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    Health Canada Details New Confidential Info Disclosures in Draft Guidance

    Health Canada is proposing to disclose more confidential business information (CBI) to eligible persons for the purpose of protecting or promoting human health or the safety of the public, according to new draft guidance. The disclosure of such CBI, approved under the Protecting Canadians from Unsafe Drugs Act (also known as Vanessa's Law) of 2014, stipulates that the Minister of Health may disclose CBI “about a therapeutic product without notifying the person to whose...
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    Health Canada Outlines 2016 Deficiencies at Actavis, Sanofi, Gilead and Other Manufacturing Facilities

    As part of Health Canada’s transparency push , the regulator is unleashing new information about its work, including an updated good manufacturing practice (GMP) inspection database that reveals new GMP deficiencies for Actavis, Sanofi-Aventis, Gilead, Baxter and other manufacturing facilities from inspections conducted in January 2016. Although none of the findings of the inspections have been listed on Health Canada’s inspection tracker , and specific details on the...
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    Health Canada Makes New Transparency Pledge

    Over the next three years, Health Canada says it will enhance its early warning systems on drug and device safety issues, particularly those in other countries, further communicate explanations for regulatory decisions and update and expand guidance on regulatory requirements. The plan, laid out by the agency this week, also points to the need for more inspections of pharmaceuticals, medical devices and other health product businesses that it regulates. Building off of...
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    Health Canada to Require Precautionary Statements in Antimicrobial Labels

    As part of efforts to encourage the more prudent prescribing and use of antimicrobials, Health Canada on Monday announced it will now require the inclusion of precautionary statements in antimicrobial product labelling. The proposal, which was announced alongside the kickoff of World Antibiotic Awareness Week , comes as bacteria are increasingly stronger, more resistant to antibiotics and therefore more lethal. As part of its federal action plan on antimicrobial resis...