Planning a Health Canada PRCI Compliant Submission
How to set yourself up for a successful Health Canada PRCI submission
Tag: カナダ保健省（Health Canada）
FDA Seeking Feedback on Drug Approval Transparency and Disclosure Efforts
Background In 2018, the Food and Drug Administration (FDA) launched a pilot to test the capability of publicly posting summaries of the safety and efficacy information that is used to make drug approval decisions. This followed suit with the European Medicine Agency’s (EMA) Policy 0070 that launched in 2015 and Health Canada’s (HC) Clinical Information … Continued
Health Canada eCTD Update
Last month, Health Canada announced an update to the mandatory use of the electronic Common Technical Document (eCTD) format. As with other agencies and regions, this helps move Health Canada towards a common submission intake process, as well as standardize and improve its business processes and tools. Previously, as of January 2018, New Drug Submission … Continued
Clarifying Health Canada’s Public Release of Clinical Information Draft Guidance – Part II
Last week we shared Part I of our three-part series on the questions and clarifications we submitted to Health Canada regarding their draft guidance on the Public Release of Clinical Information. Many thanks to everyone who commented with their insight. Following is Part II. Please leave your comments below to keep the conversation going. Health … Continued
Questions Regarding the Public Release of Clinical Information Draft Guidance – Part I
Synchrogenix’s experts and thought leaders have a pulse on the future impact of decisions made today, which is why we offer comments on global draft guidances on behalf of life science companies worldwide. Nirpal Virdee, Synchrogenix’s Director of Client Services and Technology, recently submitted feedback to Health Canada regarding their draft guidance on the Public … Continued
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