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Regulatory Perspective on ICH

Toshi TOMINAGA, Ph.D.Associate Executive Director

Pharmaceuticals and Medical Devices Agency (PMDA)

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Guideline Formulation and Regulators

ICH Harmonization Process

Implementation

Assembly Adoption of ICH Guideline

Regulatory Consultation and Discussion

Endorsement by the Assembly

Consensus on draft Technical Document

Selection of New Topic for Harmonization

Step 1

Step 2

Step 3

Step 4

Step 5

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Regulators & Industry Members Regulators only

Pre

Step1

Proposal by Members/Observer

Agreement by Assembly to initiate

Rapporteur from Reg. or Ind. member

When there is no consensus,

Regulators can adopt Concept Paper

Regulatory Chair to WG

Step 1 WG consensus on draft tech. doc.

Step 22a (whole Assembly endorse

technical document )

2b (Regulatory Assembly members

endorse Draft Guideline)

Rapporteur from Reg. member

Step 3 Consensus in WG Public Consultation by Regulators

Step 4Final Document adopted by Regulatory

Assembly members

Step 5 Implementation by Regulatory members

Regulators’ Role in Harmonization Process

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1. Eligibility for a Regulatory Member

– Implementation of Q1, Q7, E6 (Tier 1)

2. Implementation of ICH GLs (Rules of Procedure for Assembly 1.1.3 )

1. All ICH Regulators should implement all ICH Guidelines.

2. Priority on Tier 2 GLs (E2A, E2B, E2D, M4, M1) and then others (Tier 3)

3. In nation/region’s implementation, no requirements should be added or

omitted from ICH Gls.

4. Assembly monitors and discusses Regulatory Members’ Gl implementation.

Implementation of Guidelines

Step 5:

Implementation

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Japan’s Clinical Trials and ICH Guidelines

722

500

406

381

463424

422

382

406

534

499 508524

560

632

689

556601

601

657

38

82113

134

123

137 173181

227

0

100

200

300

400

500

600

700

800

Year CT Notification MRCT

ICH-GCP enforced

E5 expanded Acceptance of

Foreign Clinical Data

Japan’s Modernization of Clinical Trials- Numbers of trials and MRCT -

Total

MRCT

CT Notification

1996 1998 2000 2002 2004 2006 2008 2010 2012 2014 2015

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MRCT and US/Japan Development Lag for Drugs Approved in Japan (2007-2012)

localLocal

&

Foreign

Bridging

MRCT

T. Ueno et al.

Clin. Pharmacol. Ther. 95 533-541 (2014)

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15.4

11.9

9.2

6.5

6.17.2

8.8 8.7 8.8

22.0

19.2

14.7

11.5

10.3

11.3 11.9

11.3

11.6

0

5

10

15

20

25

2008 2009 2010 2011 2012 2013 2014 2015 2016

Priority Review Standard Review

(Months)

Review Time (Median) for New Drugs Drug Lag against U.S.

Review Time and Drug Lag in Japan

0

0.5

1

1.5

2

2.5

3

3.5

2007 2008 2009 2010 2011 2012 2013 2014 2015

Development Lag Review Lag

(Months)

42

36

30

24

18

12

6

0

12

E6 (GCP)

E5

(Bridging)

E17 (MRCT)

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Rapporteurs for WGs (EWG/IWGs active as of Mar. 2017)

Member WG with its Rapporteur

MHLW/PMDA E2B, E11, E17, M2*, M8, M10, S3A 7

FDA E18, S9, Q3C, Q3D, M2*, M7 6

EC/EMA S5, E9, M2*, M9, Q11 5

JPMA 0

PhRMA Q12, S1, S11, E14/S7B 4

EFPIA M1 1

Health Canada 0

Swissmedic 0

Total 23

“Rapporteur” leads the scientific discussion in WGs. * ”Co-Rapporteurs” are nominated for M2 WG.

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Use of ICH Guidelines in ASEAN

ACTR: ASEAN Common Technical Requirements

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PMDA Asia Training Center’s Programs

MRCT/GCP Inspection WorkshopAPEC Pilot CoE Program, Jan. 23-26, 2017

Pharmacovigilance WorkshopAPEC Pilot CoE Program, Feb. 6-9, 2017

32 participants from 14 EconomiesMalaysia, Philippines, Chinese Taipei, Indonesia, Peru,

Brazil, Myanmar, Sri Lanka, Tanzania, Thailand,

China, Mexico, Nepal, Papua New Guinea

28 participants from 15 EconomiesChile, China, India, Indonesia, Korea, Malaysia, Myanmar, Nepal, Peru, Philippine, Poland, Singapore, Taiwan, Thailand

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Results of the Surveys on Trainees

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Toshi TOMINAGA, Ph.D.

Associate Executive Director

Pharmaceuticals and Medical Devices Agency (PMDA)

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