Product registration and drug approval process in us
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Product registration and drug approval process in us
- 24. 1.0 Regional Administrative Information 1.1 ToC of Module 1 or overall ToC, including Module 1 2.1 ToC of the CTD (Mod 2,3,4,5) 2.2 Introduction 2.3 Quality Overall Summary 2.4 Nonclinical Overview 2.5 Clinical Overview 2.7 Clinical Summary 2.6 Nonclinical Written and Tabulated Summaries Module 1 Module 3 Module 4 Module 5 2.1 2.2 2.3 2.4 2.5 2.6 2.7 1.0 Quality Nonclinical Study Reports Clinical Study Reports Module 2
- 31. NDA Review Process
- 37. NDA ANDA Applicable for new drug Applicable for generic drug Take longer time ( 12-15 years) Compare to NDA less time taken(1-2 years) More expenditure of money Comparatively less Cost of drugs are more Cost of drugs are less Nonclinical studies and clinical investigations are essential Nonclinical studies and clinical investigations are nonessential except bioavailability and bioequivalence