Provide a summary overview of the existing Food and Drug Regulation requirements for a new drug
In this essay assignment, you are asked to provide a summary overview of the existing Food and Drug Regulation requirements for a new drug, highlight the limitations that exist within this existing framework for the market approval of Advanced therapeutic products (ATP), and (briefly) propose and develop an alternative regulatory framework for ATPs that overcome your limitations.
The length of the assignment should be 3-5 single spaced pages, 2.54cm margins, calibri 10 point font. The assignment will be worth 20% of your final grade.
Section 1:
Summary overview of the existing Food and Drug Regulatory framework for new drugs (10 points)
Provide an overview of the evidentiary requirements to demonstrate safety, efficacy, and quality of a new drug as prescribed in the current Division 8 of the Food and Drug Regulations
Section 2:
Limitations for market access to ATPs within the existing Regulatory Framework (15 points)
– Using an example of an ATP from the literature, highlight the limitations to market access for ATPs that exist within the current Division 8 regulatory framework
– Discussion of existing Health Canada policies associated with accelerated access to medicines (e.g. priority review, conditional NOC) should be provided. Discussion should focus on how these policies do, or do not, address the limitations you have identified.
Section 3:
Brief proposal for an alternative regulatory framework for ATPs. (20 points)
– Drawing on the limitations identified in section 1, propose a new regulatory framework (process and requirements) that you believe would facilitate access to ATPs.
– The proposed framework should strike the appropriate risk/benefit balance for the ATP, discussion of how this balance was considered needs to be provided.
References (5 points)
– References should be appended and are not included in the page limit.
– Reference style is the student’s choice, however in text citation should use a numbering system, either in parentheses or superscript.
– A minimum of 10 references are required.
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