fostering further collaboration between pmda and applicants with efficient “project ... ·...

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

Pharmaceuticals and Medical Devices Agency, Japan

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2© 2015 DIA, Inc. All rights reserved. 12th Annual Meeting DIA JAPAN 2015 | November 15-17 | Tokyo Big Sight | Ariake

2. The Elements of Project and Priority

3. Progress Management of Approval Review Process

4. Progress Management of Scientific Advice process

Outline of Presentation

© 2015 DIA, Inc. All rights reserved. 12th Annual Meeting DIA JAPAN 2015 | November 15-17 | Tokyo Big Sight | Ariake 3

1. Current Situation of Approval Review

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

PMDA: Pharmaceuticals and Medical Devices Agency


EU US Canada Switzerland AustraliaJapan

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>





3. Project Management for Process of Approval Review

4. Project Management for Process of Scientific Advice


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 ResourceScope,Quality

Top Priority(Mandatory Goal)

Second Priority(Goal to Strive)

Allowance

Flow of Review for New Drugs (in the past)

© 2015 DIA, Inc. All rights reserved. 12th Annual Meeting DIA JAPAN 2015 | November 15-17 | Tokyo Big Sight | Ariake

PMDA’s Evaluation

PMDA’sOpinion

PAFSCApprovalby MHLW

NDAFilling

Pre-SubmissionMeeting

PMDA MHLW

List ofQuestions

to Applicant

PMDA’s Evaluation

ExternalExpert

Discussion

Submission

10

InitialMeeting

AssessmentReport

StandardReview

1.9-2.5months

0.2-0.7months 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 ApplicationPMDA: Pharmaceuticals and Medical Devices AgencyPAFSC: Pharmaceutical Affairs and Food Safety Council

Pre-submission Meeting for Approval Review


Flow of Review for New Drugs (at present)


PMDA’s Evaluation

PMDA’sOpinion

PAFSCApprovalby MHLW

NDAFilling


PMDA MHLW

List ofQuestions

to Applicant

PMDA’s Evaluation

ExternalExpert

Discussion

Submission

12

InitialMeeting

AssessmentReport

Standard Review

Priority Review

2.4months

0.6months

1.9months

0.3months

5.7 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 ApplicationPMDA: Pharmaceuticals and Medical Devices AgencyPAFSC: Pharmaceutical Affairs and Food Safety Council

Flow of Scientific Advice for New Drug Development


PMDA’s Evaluation

MinutesScheduling


List ofQuestions

to Applicant

PMDA’s Evaluation

Intention

to Apply

14

1 week (2-5 weeks) 1 week

2 months (8-11 weeks)

PreparingDocument

Submission of

Document

Response to

List of Questions

PMDA’sOpinion

to Applicant

Face toFace

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>

(N)

Example of the GANNT chart (I)


Global Phase III trial

Japan

US &

EU

Phase II trialPhase I

trial

Phase II trialPhase 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 4Q

Scientific 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 AgencyFDA: US Food and Drug AdministrationlPMDA: Pharmaceuticals and Medical Devices Agency

Example of the GANNT chart (II)


Global Phase III trial

Japan

US &

EU

Phase I trial

Phase IIa trialPhase 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 4Q

FDA, 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 AgencyFDA: US Food and Drug AdministrationlPMDA: Pharmaceuticals and Medical Devices Agency

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)


「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.

E-mail: [email protected]

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