Latest News
Regulatory Update
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3 April 2013
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Health Canada has released revised draft guidance concerning the safety and efficacy requirements necessary to obtain market authorization for disinfectants and disinfectant-sanitizers in Canada.The
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Latest News
Regulatory Update
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20 March 2013
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Health Canada has announced that as of 1 June 2013, all “administrative regulatory” submissions must be in electronic format only, submitted either as an electronic common technical document (eCTD) or
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Latest News
Regulatory Update
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22 February 2013
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Health Canada has announced that generics companies will have soon have timely access to new safety-labeling changes made to the Product Monographs (PM) for Canadian Reference Products (CRPs),
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Latest News
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20 February 2013
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Canadian regulators have released a new draft revised guidance that it says will clarify a previous guidance on look-alike, sound-alike (LASA) names that seeks to protect consumers from drug
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Latest News
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11 February 2013
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Canadian regulators have announced the suspension of all medical device licenses issued to or otherwise associated with one medical device manufacturer after being made aware of "concerns about the
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Regulatory Update
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2 January 2013
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Health Canada has opened a consultation regarding the new Prescription Drug List that is scheduled replace the existing Schedule F of the Food and Drug Regulations. The regulatory process to add or
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Latest News
Regulatory Update
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21 December 2012
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Health Canada will be requesting Development Safety Update Reports (DSURs) from selected sponsors of clinical trials for pharmaceuticals, biologics and biotechnology products, vaccines, and blood
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Latest News
Regulatory Update
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17 December 2012
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As of April 2013, Health Canada intends to provide public access to its own clinical trial database covering Phase I, II and III drug trials that have been authorized in Canada.The database is seen as
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Latest News
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12 December 2012
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Regulatory agencies are often seen as being in competition with one another. When the European Medicines Agency (EMA) approves a cancer drug before the US Food and Drug Administration (FDA), that's
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Latest News
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5 December 2012
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Canadian regulators are scrambling to re-evaluate more than 20 companies' approved and pending products after finding "falsified" testing results during the course of an inspection at Ontario-based
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