• Regulatory NewsRegulatory News

    Health Canada Overruled on Apotex Import Ban

    A Canadian federal court has ruled against Health Canada’s decision to restrict pharmaceutical imports from two Apotex facilities in India, though the US FDA still bans products from these facilities. In its ruling from 14 October, the court noted that Health Canada and Health Minister Rona Ambrose proceeded unfairly and acted for an improper purpose. The ruling also requested Health Canada and Ambrose retract its statements on Apotex, which they did Tuesday. And altho...
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    FDA Bans Pharma, Nutraceutical and Cosmetic Imports from Canadian Company

    The US Food and Drug Administration (FDA) has added Canada's Cosmetic Manufacturers Inc. (CMI) to a list of companies that have been banned from shipping products to the US. CMI manufactures cosmeceuticals, nutraceuticals and pharmaceuticals, including a digestive enzyme therapy, according to its website . The company says it has a Drug Establishment License and owns the rights to many Drug Identification Number products under the CMI name. The updated FDA import alert...
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    Canada's Medical Marijuana Regulations, An Overview

    Following is a free preview of a Regulatory Focus feature article, normally exclusively available to RAPS members. For information about becoming a member, visit Join RAPS . This article presents an overview of Canada's medical marijuana regulations regarding individual prescription access and compliance measures for licensed producers. The narcotic marijuana (spelled "marihuana" in most official Canadian government communications) is not an approved drug or medicin...
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    Canada Launches Ebola Vaccine Trial

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. The Canadian Institutes of Health Research (CIHR) and the Public Health Agency of Canada (PHAC) have provided funding for a Phase I clinical trial using Canada’s Ebola vaccine (VSV-EBOV), Canada's Minister of Health, Rona Ambrose, announced last week.  The Canadian Im...
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    Latest Information on Health Canada Review and Approval Times for MDEL Applications

    Content provided by Emergo Group , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. Health Canada regularly publishes performance data with respect to Medical Device License applications (Class 2-4); however, the data publically available for Medical Device Establishment License (MDEL) applications has generally been limited.  To gain a better understanding of MDEL applications, Emergo's Vancouver office contacted H...
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    Recent Changes to the Regulation of ‘Food-Like’ Natural Health Products in Canada

    The Canadian regulatory landscape for foods and natural health products (NHPs), which are roughly equivalent to US dietary supplements, has experienced significant recent change. The change is a result of an updated Health Canada regulatory policy under which many “food-like” NHPs––products at the food-NHP interface that meet the definition of both a food and an NHP––will be classified and regulated exclusively as foods. As a consequence, thousands of products ha...