Kazuishi Sekino
Review Director
Office of New Drug I
Pharmaceuticals & Medical Devices Agency
Fostering Further Collaboration
between PMDA and Applicants with
Efficient “Project Management” in
Drug Development
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2. The Elements of Project and Priority
3. Progress Management of Approval Review Process
4. Progress Management of Scientific Advice process
Outline of Presentation
Review Time for New Drugs (median)
The PMDA’s Second Mid-term Plan
<https://www.pmda.go.jp/files/000206389.pdf>
(Total review time = Regulatory review time + Applicant’s time)
(Numbers of
approved products)
(Months)
FY2014
The PMDA’s Third
Mid-term Plan
EU
US
Japan
Canada
Switzerland
Australia
Regulatory Affairs Professional Society
2015/1/14
Six regulatory Authorities’ Approval Time of New Drugs in
2004-2013
FY2014
FY2015
FY2016
FY2017
FY2018
Target
percentile
60%
60%
70%
70%
80%
The PMDA’s Third Mid-term Plan
（
FY2014 to FY2018
）
The plan for prompt realization of “zero” review lag for new drugs
Review Time for New Drugs (
Priority Review
)
Total review time
(Regulatory review time + Applicant’s time)
；
9 months
（
6 months + 3 months
）
Review Time for New Drugs (
Standard Review
)
Total review time
(Regulatory review time + Applicant’s time)
；
12 months
（
9 months + 3 months
）
<http://www.pmda.go.jp/guide/jyohokokai/kohyo/file/1-7keikaku3.pdf>
Outline of Presentation
2. The Elements of Project and Priority
3. Project Management for Process of Approval Review
4. Project Management for Process of Scientific Advice
1. Current Situation of Approval Review
The Three Elements of Project and Priority
Project
「プロジェクトマネジメント 理論編（第
2版）」総合法令出版 一部改変
Time
(start and end
time, the
necessary time)
Scope,
Quality
(different each
time)
Resource
(reviewers)
Time
Resource
Quality
Scope,
Top Priority
(Mandatory Goal)
Second Priority
(Goal to Strive)
Outline of Presentation
2. The Elements of Project and Priority
3. Project Management for Process of Approval Review
4. Project Management for Process of Scientific Advice
1. Current Situation of Approval Review
Flow of Review for New Drugs (in the past)
PMDA’s
Evaluation
PMDA’s
Opinion
PAFSC
Approval
by MHLW
NDA
Filling
Pre-Submission
Meeting
PMDA
MHLW
List of
Questions
to Applicant
PMDA’s
Evaluation
External
Expert
Discussion
Submission
Initial
Meeting
Assessment
Report
Standard
Review
1.9-2.5months months0.2-0.7 4.7-8.3 months 1.2-1.9 months 0.7-1.9 months
Standard Review: Total 12 months
Priority Review: Total 9 months
<Administrative Notice of MHLW, March 30, 2012>
MHLW:Ministry of Health, Labour and WelfareNDA:New Drug Application
PMDA:Pharmaceuticals and Medical Devices Agency
Flow of Review for New Drugs (at present)
PMDA’s
Evaluation
Opinion
PMDA’s
PAFSC
Approval
by MHLW
NDA
Filling
Pre-Submission
Meeting
PMDA
MHLW
List of
Questions
to Applicant
PMDA’s
Evaluation
External
Expert
Discussion
Submission
Initial
Meeting
Assessment
Report
Standard
Review
Priority
Review
2.4 months months0.6 1.9 months months0.35.7 months 1.5 months 0.9 months
4.4 months 1.3 months 0.8 months
Standard Review: 12 months
Priority Review: 9 months
<Administrative Notice of MHLW, January 30, 2015>
MHLW:Ministry of Health, Labour and WelfareNDA:New Drug Application
PMDA:Pharmaceuticals and Medical Devices Agency
Outline of Presentation
2. The Elements of Project and Priority
3. Project Management for Process of Approval Review
4. Project Management for Process of Scientific Advice
Flow of Scientific Advice for New Drug Development
PMDA’s
Evaluation
Minutes
Scheduling
Pre-Submission
Meeting
List of
Questions
to Applicant
PMDA’s
Evaluation
Intention
to Apply
1 week (2-5 weeks) 1 week
2 months (8-11 weeks)
Preparing
Document
Submission of
Document
List of Questions
Response to
PMDA’s
Opinion
to Applicant
Face to
Face
Meeting
Response to
PMDA’s Opinion
1 week 1 month (1 week) (1 week)5 weeks
Applicant’s
Action
Number of Scientific Advice for New Drugs
(Review Category 1; Gastrointestinal Drugs etc.)
<https://www.pmda.go.jp/0017.html>
Example of the GANNT chart (I)
Global Phase III trial
Japa
n
US
& EU
Phase II trial
Phase I
trial
Phase II trial
Phase I
trial
2013 2014 2015 2016 2017 2018 2019 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4QScientific Advice
Applicant’s
Decision Making
FDA, EMA
PMDA
Top-Line Results
Delay of
enrollment of
Japanese patients?
Reflection of
PMDA’s opinion
to protocol?
PMDA
FDA, EMA
Best
timing?
【
Hypothetical situation
】
EMA:European Medicines Agency
FDA:US Food and Drug Administrationl
Example of the GANNT chart (II)
Global Phase III trial
Japa
n
US
& EU
Phase I
trial
Phase IIa trial
Phase I
trial
2014 2015 2016 2017 2018 2019 2020 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4QFDA, EMA
PMDA
Global Phase II
trial
Reflection of
PMDA’s opinion
to protocol?
Best
timing?
FDA, EMA, PMDA
Best road
map?
【
Hypothetical situation
】
Scientific Advice
Applicant’s
Decision Making
Top-Line Results
EMA:European Medicines Agency
FDA:US Food and Drug Administrationl
Items for the Project Management
Examples of items for the project
management
–
The target product profile
–
The strategic development plan (and current
status)
–
The GANNT chart (development history and
project scheduling, including discussion to
regulatory agencies)
etc.
Project
Time
(starting and
ending time, the
required time)
Scope,
Quality
(different each
time)
Resource
(reviewers)
Effective utilization of pre-submission meeting
(sharing the information between applicant
and PMDA)
PMDA:Pharmaceuticals and Medical Devices Agency 「プロジェクトマネジメント 理論編（第2版）」総合法令出版 一部改変
Welfare of patients!
Thank you for your attention.
