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Prepare A Document Outlining The Systems For Registration Of A Generic Medicinal Product: Regulatory Affairs Essay

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.
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