The changing landscape of the life sciences industry makes it necessary for the companies to adapt to the global Regulatory requirements, immediately. Companies need to evolve themselves for the necessary transition with each mandatory requirement from the health authorities.
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December 30, 2019 Regulatory Affairs, Publishing & Submissions -
September 27, 2019 Regulatory Affairs, Publishing & SubmissionsHealth Canada (HC) again postpones the mandatory deadline for Drug Master File (DMF) submissions in electronic Common Technical Document (eCTD) format. Referring to the authority’s May 2018 notification, the earlier deadline was Jan 1, 2019 which later got postponed to Sep 01, 2019.
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April 8, 2019 Regulatory Affairs, Publishing & SubmissionsHealth Canada (HC) announced the revision of the validation rules for Regulatory transactions in electronic Common Technical Document (eCTD) format and published them as Version 4.4 on March 6, 2019.
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February 20, 2019 Medical DevicesHealth Canada (HC) has one of the most stringent regulations for medical devices. To further increase the safety and effectiveness of devices, and optimize the health outcomes for end-users, the Canadian health authority (HA) is aiming to strengthen the current Regulatory framework. The three-part strategy announced recently as an action plan is the part of the same.
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December 27, 2017 Publishing & SubmissionsWe hope you have taken necessary inputs on Health Canada (HC) eCTD format and its content structure from our previous write up.
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December 7, 2017 Publishing & SubmissionsThe health authority of Canadian landscape, Health Canada (HC) has revised the submission requirements and mandated submissions to be in electronic format for certain filings post January 1st, 2018.
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May 25, 2017 Publishing & Submissions, Health Authority UpdatesWith the FDA concluded its mandatory first phase electronic submissions deadline, first question drug manufacturers could ask themselves is what’s next in line? Where else they can submit their data and which format they should get adopted to? With their target focused on global markets, we suggest to take one-at-a-time approach.
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August 30, 2016 Pharmaceutical, Regulatory Labeling, Health Authority UpdatesIn a recent study in Canada, it was observed, “1 in 9 emergency cases were related to drug adverse events, and as many as 68% of those were preventable”. Prevention is better than cure. Having learnt that, the first and foremost task for the companies is to look at the ways that prevent the adverse events?
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July 20, 2016 Pharmaceutical, Publishing & Submissions, Health Authority UpdatesDo you know? The United States Food and Drug Administration (US FDA) has mandated that certain Regulatory submission types (NDA, BLA, and ANDA) should be filed in electronic Common Technical Document (eCTD) format beginning May 5, 2017.
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May 10, 2016 Medical Devices, Regulatory Labeling, Health Authority UpdatesAfter a prolonged duration of 18 years, IVD (In vitro Diagnostic) Medical Devices finally fall under the purview of Health Canada’s much awaited finalized labeling guidance. The first draft of this guidance was issued in the year 1998. This guidance emphasizes mainly on: