Level 6 Assignment: Introduction to Regulatory Affairs

Introduction:

 Please select a mini-project of your choice on Moodle.

 A maximum of 20 people can be assigned per project. Project preferences will be on a first come first
serve basis.

 Project should be no less than 2,000 words and no more than 3,500 words (excluding references,
admin pages etc.)

 Each person must complete the project individually. Please note identified inappropriate use of AI will
result in a fail.

 Project is worth 30% overall. Please utilise graphical representations as appropriate.

 Due date for the project is 20th April 2025.

 Projects will need to be submitted via Turnitin (link will be on moodle) along with a presentation (5-
10 slides) – a sample cohort may be requested to present online.

1. Authorization of a Generic Medicinal Product in Europe
You are required to prepare a document outlining the systems for marketing authorisation in Europe of a generic Medicinal product that has already been approved in Germany. To this end you are required to carry out:

Part A) A review of the different types on National Authorisation Procedures (8 Marks)

Part B) Identify a procedure you wish to undertake and explain why you chose that procedure (8 Marks)

Part C) How will you now get approval for your medicinal product in post Brexit UK? (5 Marks)

Part D) If your product was innovative and was for a highly infectious disease would it impact the registration process? Explain your answer and provide an overview of the alternative pathways that might be available to you (5 Marks)

Part E) Presentation (4 Marks)

2. Drug Approval process of an innovative Medicinal Product in US
You are required to prepare a document outlining the drug approval process of an innovative human Medicinal
product in the US (not a biologic product). To this end you are required to carry out:

Part A) Brief description of the drug discovery and approval process for an innovative drug on the US market (8 Marks)

Part B) Overview of the NDA process and rationale as to what specific regulatory pathway you will use to obtain market (8 Marks)

Part C) Prior to deciding on the regulatory pathway for any NDA Submission what questions should be
addressed to indicate the correct pathway? Explain your answer (5 marks)

Part D) If your product was generic would it impact the registration process? Explain your answer and provide
an overview of the alternative pathways that might be available to you (5 Marks)

Part E) Presentation (4 Marks)

3. Registration of a generic Biological Product in US

You are required to prepare a document outlining the systems for marketing approval of a generic biological product in the US. To this end you are required to carry out:

Part A) A detailed review of the FDA – functions and activities of the core FDA review centre you will be
dealing with and the main legislative acts to which you must comply (8 Marks)

Part B) Overview of the BLA process and timeline for a generic biological product approval by the FDA. (8 Marks)

Part C) Provide an overview of what regulatory pathway you would follow if this was An innovative biological product. (5 marks)

Part D) Why are changes in the manufacturing process, equipment or facilities for a Biological Product
viewed so seriously by the FDA? How are changes like this managed? Explain your answer (5 Marks)

Part E) Presentation (4 Marks)

4. Registration of an Innovative Biological Product in EU

You are required to prepare a document outlining the systems for registration of an innovative biological product in the EU. To this end you are required to carry out:

Part A) Explain what an ATMP is and how it can be regulated in the EU (8 Marks)

Part B) Overview of the Centralised procedure (8 Marks)

Part C) Define a Biosimilar product and provide an overview of what regulatory pathway you would follow if this was a biosimilar product. (5 marks)

Part D) A review of the Committee for Medicinal Products for Human Use (CHMP) – functions and activities (5 Marks)

Part E) Presentation (4 Marks)

5. The role of the ICH and application of the CTD drug registrations
You are required to prepare a document outlining the systems for registration of Medicinal products including Biopharmaceuticals, using the CTD approach. To this end you are required to carry out:

Part A) A detailed overview of the ICH – functions and activities and documents they generate (8 Marks)

Part B) Overview of the Common Technical Document and its different sections. (8 Marks)

Part C) Detailed review of how the CTD approach spans across the member regions regulatory approaches i.e.

how can one document fit for INDs, NDAs, IMPDs, centralised approach. What is the base template? (5 Marks)

Part D) What is the ICH MedDRA? What is its use/function? (5 Marks)

Part E) Presentation (4 Marks)

6. Summary of EPAR and Marketing Application Review
The European Public Assessment Report (EPAR) for Icandra is a diabetes medicine that is used together with diet and exercise to control the blood glucose (sugar) in adults with type 2 diabetes. : Icandra (previously Vildagliptin / metformin hydrochloride Novartis) | European Medicines Agency (EMA)

Part A) Summarize the basis for approval in your own words. Include the following elements in your report: Introduction and Summary, indication and mechanism of action. (8 Marks)

Part B) Summarize the Quality Safety and Efficacy data submitted for this product and discuss the overall benefit risk analysis. (8 Marks)

Part C) How is it indicated on a healthcare product that additional monitoring is ongoing? Give 5 examples of why some products will undergo additional monitoring (5 Marks)

Part D) What is an Advanced therapy medicinal product (ATMP)? List two ATMPs on the market in the EU – provide links to their associated EPARs (5 Marks)

Part E) Presentation (4 Marks)

7. Summary of EPAR and Marketing Application Review

The European Public Assessment Report (EPAR) for Drovelis is a combined contraceptive pill that contains two active substances, drospirenone (a progestogen) and estetrol (an oestrogen). Estetrol is a synthetic version of an oestrogen that is naturally present during pregnancy, and drospirenone is a hormone with similar effects to the progesterone produced during the menstrual cycle. Both these substances change the body’s hormonal balance to prevent ovulation.. : Drovelis | European Medicines Agency (EMA)

Part A) Summarize the basis for approval in your own words. Include the following elements in your report:
Introduction and Summary, indication and mechanism of action. (8 Marks)

Part B) Summarize the Quality Safety and Efficacy data submitted for this product and discuss the overall benefit risk analysis. (8 Marks)

Part C) How is it indicated on a healthcare product that additional monitoring is ongoing? Give 5 examples of why some products will undergo additional monitoring (5 Marks)

Part D) What is an Advanced therapy medicinal product (ATMP)? List two ATMPs on the market in the EU – provide links to their associated EPARs (5 Marks)

Part E) Presentation (4 Marks)