Transcript www.ozanbatigun.com

•
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
• 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
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