Module 3 Presentations

14/05/2024

Regulator’s and Company Interests

 Quality  Safety  Efficacy

Needed to apply for MA/NDA/BLA

 Regulators want safe and efficacious products on the market but not at any cost to patient health  Companies need to be realistic about new drugs and kill projects early

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Typical Timeline and Cost for Medicine Development

CMC Development

Post approval changes: • New formulation(s)

• Improved DS synthesis • New indications etc

From ABPI November 2019 6

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