Registration of a generic Medicinal Product in the US
You are required to prepare a document outlining the systems for registration of a generic medicinal product in the US.
To this end you are required to carry out:
- A detailed review of the FDA
- functions and activities of the core FDA review centre you will be dealing with
- Overview of the NDA process and rationale as to why you would pick a 505(b)(2) pathway or a 505(j) ANDA pathway
- An Overview of what regulatory pathway you would follow if this was an innovative medicinal product.
In your answer please include the following details:
- The classification of the device and the appropriate regulation used in determining the classification for both the EU and US
- The rationale for classification applied for both the EU and the US.
- Identification of appropriate submission type for both the EU and US.
- Outline of post-market requirements for the chosen submission type for both the EU and US.