The role of the ICH and application of CTD drug registrations You are required to prepare a document outlining the systems for the 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)