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    New Electronic Formatting Requirements in Canada for Class III and IV MDL Applications

    Content provided by Emergo Group , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. Health Canada, Canada’s medical device market regulator, has published new  guidance  requiring electronic formatting for most higher-risk Class III and IV Medical Device License (MDL) applications. Set to take effect 1 December 2014, the new rules will require Class III and IV MDL applicants to submit premarket review documentation...
  • Regulatory NewsRegulatory News

    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...
  • India Moves to Grant Three More Compulsory Licenses for Cancer Medications Based on Cost

    • 03 May 2013
    India's Union Health Ministry is pursuing three more compulsory licenses that would allow generic manufacturers in the country to compete with patent-protected medicines, including Roche's Herceptin and Bristol-Myers Squibb's Sprycel and Ixabepilone, reports PharmaBiz .  The announcement comes just months after the country's Supreme Court issued a landmark compulsory license for Bayer's Nexavar (sorafenib). What made that decision so remarkable to both critics...
  • India's Top Regulator Prepares for a Future Without Branded Medicines

    • 16 October 2012
    The Times of India reports that India's top regulatory official, the drug controller general of India, Dr. G N Singh, eventually wishes to do away with branded or patented medicines in favor of a generics-only system he says will benefit the public before all others. "We want to gradually move towards a future where we will not issue any brand or trade names," The Times reported Singh as saying. "Gradually" may come faster than some pharmaceutical companies may ...
  • Landmark Ruling Clears Way for Use of Compulsory License in India

    In a decision upholding a landmark ruling, India's Intellectual Property Appellate Board (IPAB) has upheld a compulsory license granted by the controller of patents earlier in 2012, clearing the way for generics manufacturers to introduce low-cost versions of German pharmaceutical manufacturer Bayer's cancer drug Nexavar (sorafenib). At issue for Bayer was the country's use of the compulsory license-a concept first established under the Trade-Related Aspects of Intelle...
  • New Chinese Patent Rules Could Make Country Compulsory Licenser to the World

    Following closely in the footsteps of India , China has announced the release of a new patent system in which it can grant compulsory licenses to generic pharmaceutical manufacturers to allow them to make copies of on-patent branded medicines. Compulsory licenses are used by countries to override patents when a country deems that a health crisis warrants such action. While compulsory licenses have been granted in moderation since the signing of the Doha Declaration ...
  • PLoS: Pressures on Doha Declaration Signatories Preventing Overuse of Compulsory Licenses

    • 12 January 2012
    A recent study in the Public Library of Science's (PLoS) Medicine journal provides a review of the Doha Declaration , and finds that the issuance of compulsory licenses (CLs) dropped significantly after 2006, and that upper-middle-income countries (UMICs) face barriers to utilizing CL's excessively. Compulsory licenses are used by countries to override patents when the country deems that a health crisis warrants such action. When the Doha Declaration was first sig...