Question 1 The NDS for your human pharmaceutical was approved by Health Canada last year. The quality team has informed you a Post-NOC Change needs to be submitted in regards to the fabrication of the drug substance for your final drug product (a tablet). The new manufacturing site is located in Albany, New York, and is not listed on your DEL. Explain how you would proceed. Explain all the timelines associated with this change (i.e. DEL, Post-NOC processing, screening and review.) Identify what type of submission (SNDS, NC, Level III) this Post-NOC change involves and the level (Level I, II, III). State the modes of submission for the Post-NOC change as well as the DEL Amendment. (i.e. ESG, Email, Paper-based) For the DEL-Amendment, what GMP evidence would you submit to add this new site? In terms of the DEL Amendment to add the site, fill in the boxes below: A Category Dosage Form Class Non-Sterile Sterile Select one Identify at least two quality-related subsections of Module 1 that would be impacted in this submission. Upon approval of this Post-NOC submission, what would Health Canada issue? If you were to submit this change now, what would be the cost associated with this change? After the new facility is approved, the plan is to remove the existing manufacturing site for this drug product, which is located in Barcelona, Spain. How would you handle this from a Post-NOC submission perspective, as well as from an EL perspective? What types of submissions are involved and what are the Health Canada costs associated with this?
Question 2 You currently have an approved Phase 3 Clinical Trial Application for your biologic investigational drug product. As the activities gear up for the commercialization phase, there are plans for scale up of your drug substance. The decision has been made to do this at a new facility in Toronto, Canada. Discuss, in terms of: Type of the Post-NOC change submission required, and timelines associated with this submission Type of DEL Amendment required Health Canada costs associated with this type of change Upon approval of this submission, what would Health Canada issue?
Question 3 When your biologic product was approved by BRDD two years ago under the Notice of Compliance with conditions (NOC/c) policy, the commitment was to submit the Periodic Benefit Risk Evaluation Report (PBRER) annually until the conditions are removed for your product. As part of the commitment, you filed the annual PBRER in July 2020. After review of the report, the MHPD branch of Health Canada issued your company a letter, requesting that the higher than usual incidence of anaphylaxis should be updated in your current Product Monograph. Type of the Post-NOC change submission required, and timelines associated with this submission As per Health Canada guidance, highlight the documents (in the table below) that you would likely include in this submission.
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