Please use the case study below to answer the following
Objective of this Assignment: To prepare a response to a Request for Proposal (RFP) from a foreign drug company who wants to file a New Drug Submission to license their new drug for commercial sale in Canada. Instructions: You will compose a response to a Request for Proposal (RFP) from a foreign drug company who wants to file a New Drug Submission to obtain authorization to sell a new drug in Canada. The company also wants to obtain some information on timelines and fees to market this new drug the US. Their new drug product is a novel biologic with a new active substance administered to subjects intravenously which is intended to be approved to treat a life-threatening disease known as “Fabry disease”. As a Regulatory Affairs Associate and using your Regulatory Subject Matter Expertise, you will respond to their inquiries by addressing the questions below and relying on the instructions provided in table 1 and table 2 on pages 2 and 3. How long does the New Drug Submission (NDS) review process take and what is the typical process/steps? What kind of information do we need to supply in the NDS Modules? How much does a NDS cost in Canada? Is there is an opportunity for submission fee reduction and if so, what are the eligibility requirements? How much does a New Drug Application (NDA) cost in the US? Is there is any opportunity for submission fee reduction and if so, what are the eligibility requirements? Is it possible to accelerate the approval timelines for the review of our NDS in Canada? If so, what are the options and eligibility requirements for the accelerated review processes? Is it possible to accelerate the approval timelines for the review of the NDA in the US? If so, what are the options and eligibility requirements for the accelerated review processes? Our drug substance and drug product are manufactured in Germany and the drug is approved for commercial sale there. What licence is required in order to import this drug in Canada and what is the application process to obtain the licence? If Health Canada assigns this novel biologic to group 2 under the Lot Release Program, what is the timeline and process to follow prior to releasing any lots for sale? Post-approval, they want to make the following changes to production process of drug in Canada: Change #1: Change in scale of the manufacturing process at the purification stage Change #2: Add a brand new manufacturing facility for the production of drug product Change #3: Update the drug product shelf-life from 3 years to 5 years When working on question 8 above, address the following questions for each of the changes: What classification is the change according to Health Canada Post-NOC guidance document? How long does it take Health Canada to review the submission types for the change and how much does it cost to file the change to Health Canada? What kind data should be included in the submission to support the change? Assignment format This term project should be submitted as one electronic file in the following tabulated format, in 2 parts: Part A: An RFP to the pre-market application Part B: An RFP to the post-market applications. You may adapt the table and headings to your choosing, but be sure to answer all the questions from your potential new client above. Table 1: Part A: Pre-market Application in Canada Questions Instructional Text: For question 1: Overview of Pre-market review process in Canada and Length of submission review. Content of a New Drug Submission in Canada (Modules 1-5). Using the appropriate guidance documents, describe the NDS review process in Canada and all the timelines of the application (screening, review, clarifax request etc.). Your response should cover all the steps from pre-submission meeting to issuance of the final decision. Furthermore, using the appropriate guidance document(s) and ICH guidance documents briefly describe the content of each Module and explain their purpose in regards to the information that they each provide to the reviewers at Health Canada. NMT 2 pages For questions 2 and 3: Cost of NDS and NDA Using the appropriate guidance documents, present the fees for the NDS Application in Canada and the NDA in the US for this novel biologic (Present as a side-by-side comparison). NMT 1/2 page For questions 2 and 3: Mechanisms to waive or reduce submission fees Using the appropriate guidance documents, describe the eligibility and process to waive or reduce fees for submissions in Canada and the US (Present as a side-by-side comparison). NMT 1 page For questions 4 and 5: Accelerated review timelines: Applicability and process Using the appropriate guidance(s), describe the options and eligibility requirements, as well as the application process/steps to reduce the submission review timelines for this novel biologic in Canada and in the US. 2 processes/options should be presented for each Jurisdiction (Present as a side-by-side comparison). NMT 11/2 page For question 6: Licensing requirements Indicate the type of licence that is required to import the drug in Canada, the application process and the documents/information that should be submitted as part of the application. For question 6: Lot Release Program Using the appropriate guidance document, describe the Lot Release process of a Group 2 biologic product. Table 2: Part B: Post-market Application in Canada N.B. Repeat Table 2 for each Post-market variation (changes 1, 2, 3) and use the Post-Notice of Compliance (NOC) Changes – Quality Guidance to address questions 8a and 8c. Questions Instructional Text For question 8a: Classify the Post-Market Variation Using the appropriate guidance documents, classify the level of change. For question 8b: Cost of Variation Application and Length of Review Using the appropriate guidance document, describe the cost of the submission and length of review in Canada. For question 8c: Data to support the Post-market variation Using the appropriate guidance document(s), list the data that should be submitted to support the post-market variation; and list any associated conditions, if applicable. N.B. It is important to list the supporting data as presented in the guidance document (same wording) with the proper numbering (#8) (e.g., 8. (1.2.5) GMP and EL information).
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