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NDA Development Plan

NDA Development Plan. Text for New Drug Development. http://www.wellcome.ac.uk/bigpicture/drug/runflash2.html. NDA Registration Plan. Mean EU approval time is approx 12 months Mean US ANDA approval time 10 months. Generic Development Plan.

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NDA Development Plan

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  1. NDA Development Plan

  2. Text for New Drug Development • http://www.wellcome.ac.uk/bigpicture/drug/runflash2.html

  3. NDA Registration Plan • Mean EU approval time is approx 12 months • Mean US ANDA approval time 10 months

  4. Generic Development Plan • A 10-stage development process to ensure rapid development and subsequent registration of generic applications • Timescale: 18 to 36 months • 1: Find out as much as you can about the brand that contain Active of choice and/or combination. • 2: Gather as many examples of the branded OTC products or RX products containing active of choice from as many markets as possible and test them • 3: Identify possible active ingredient manufacturers (AIM) - ensuring US and EU DMFs (Cert’s of Suitability) • 4: Audit AIMs and identify appropriate source • 5: Identify differences between existing product(s) and proposed • product(s). Identify critical formulation parameters which influence above • differences • 6: Develop formulation (initiate validation of methods) • Pre-screen toxicological and clinical performance if necessary –e.g., • new delivery route • 7: Develop/fine tune manufacturing process • 8: Manufacture pivotal batches for stability/ toxicological data and clinical data • 9: Clinical/bioequivalence studies, if necessary. Stability studies • 10: Gather data and submit dossier

  5. Generic Registration Plan • Submission via DCP will usually take approx 15 months for Approval in all target EU countries • Mean US ANDA approval time 18 months • Mean Approval time in other International countries/regions 12 -48 months

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