Fundamentals of Pharmaceutical and Biologics Regulations: A Global Perspective
Second Edition
6 Regulatory Affairs Professionals Society
share the longest Phase 1 transition, at 2.7 years. Oncology is the
only therapeutic area with an average regulatory review of less than
1 year the 0.8-year duration is almost half as short as the cumula-
tive total for all non-oncology indications (1.4 years). Urology
drug candidates see the longest Phase 2 duration (5.0 years). Ex-
cluding urology, the remaining therapeutic areas lie close to the
average duration of 3.6 years. Ophthalmology is the fastest disease
area for Phase 2 research (2.9 years). When looking at Phase 3
timelines, cardiovascular has the longest Phase 3 duration (4.2
years). The large patient populations in cardiovascular trials and
the long-term evaluation of cardiovascular outcomes contribute to
longer timelines than seen in other prevalent disease areas, such as
psychiatry (2.8 years), which typically assesses short-term sympto-
matic improvement using rating-scale questionnaires.
The medicinal product development continuum is a lengthy
and costly proposition with no guarantee of success. However, un-
derstanding the steps and developing a clear product development
plan, including CMC, will help minimize delays and risks and in-
crease the probability of success. To that end, a high-level sum-
mary of each step in the development continuum is provided
below, with more specific details for each step provided later in
this book.
Phase transition durations by disease area
Phase Transition Durations from Phase I
Allergy 1.5 3.8 2.9 1.1 9.2
Metabolic 2.0 3.2 3.1 1.2 9.5
Infectious disease 2.0 3.5 3.1 1.2 9.7
Ophthalmology 2.1 2.9 3.4 1.3 9.8
Autoimmune 2.1 3.6 3.2
Oncology 2.7 3.7 3.1 0.8 10.3
Respiratory 2.1 3.5 3.3 1.5 10.4
Psychiatry 2.3 3.4 2.8 1.8 10.4
Others 1.9 3.5 3.2 1.8 10.5
All indications 2.3 3.6 3.3 1.3 10.5
Endocrine 1.8 3.4 3.7 1.8 10.7
Hematology 2.2 3.4 3.6 1.5 10.7
Gastroenterology 1.6 3.9 3.9 1.4 10.8
Neurology 2.1 3.7 3.7
Cardiovascular 2.4 3.8 4.2 1.2 11.5
Urology 2.7 5.0 2.9 1.6 12.2
0 3 6 9 12
Duration of Phase Transition (Years)
Phase I to II Phase II to III Phase III to NDA/BLA NDA/BLA to Approval
Source: Biomedtracker® and Pharmapremia® 2020.
Figure 1-3. Phase Transition Duration From Phase 1 Through NDA/BLA Authorization
1.1 10.0
1.6 11.1
Second Edition
6 Regulatory Affairs Professionals Society
share the longest Phase 1 transition, at 2.7 years. Oncology is the
only therapeutic area with an average regulatory review of less than
1 year the 0.8-year duration is almost half as short as the cumula-
tive total for all non-oncology indications (1.4 years). Urology
drug candidates see the longest Phase 2 duration (5.0 years). Ex-
cluding urology, the remaining therapeutic areas lie close to the
average duration of 3.6 years. Ophthalmology is the fastest disease
area for Phase 2 research (2.9 years). When looking at Phase 3
timelines, cardiovascular has the longest Phase 3 duration (4.2
years). The large patient populations in cardiovascular trials and
the long-term evaluation of cardiovascular outcomes contribute to
longer timelines than seen in other prevalent disease areas, such as
psychiatry (2.8 years), which typically assesses short-term sympto-
matic improvement using rating-scale questionnaires.
The medicinal product development continuum is a lengthy
and costly proposition with no guarantee of success. However, un-
derstanding the steps and developing a clear product development
plan, including CMC, will help minimize delays and risks and in-
crease the probability of success. To that end, a high-level sum-
mary of each step in the development continuum is provided
below, with more specific details for each step provided later in
this book.
Phase transition durations by disease area
Phase Transition Durations from Phase I
Allergy 1.5 3.8 2.9 1.1 9.2
Metabolic 2.0 3.2 3.1 1.2 9.5
Infectious disease 2.0 3.5 3.1 1.2 9.7
Ophthalmology 2.1 2.9 3.4 1.3 9.8
Autoimmune 2.1 3.6 3.2
Oncology 2.7 3.7 3.1 0.8 10.3
Respiratory 2.1 3.5 3.3 1.5 10.4
Psychiatry 2.3 3.4 2.8 1.8 10.4
Others 1.9 3.5 3.2 1.8 10.5
All indications 2.3 3.6 3.3 1.3 10.5
Endocrine 1.8 3.4 3.7 1.8 10.7
Hematology 2.2 3.4 3.6 1.5 10.7
Gastroenterology 1.6 3.9 3.9 1.4 10.8
Neurology 2.1 3.7 3.7
Cardiovascular 2.4 3.8 4.2 1.2 11.5
Urology 2.7 5.0 2.9 1.6 12.2
0 3 6 9 12
Duration of Phase Transition (Years)
Phase I to II Phase II to III Phase III to NDA/BLA NDA/BLA to Approval
Source: Biomedtracker® and Pharmapremia® 2020.
Figure 1-3. Phase Transition Duration From Phase 1 Through NDA/BLA Authorization
1.1 10.0
1.6 11.1