1

Strategies for Regulatory Convergence including Asian Region

Cheng-Ning Wu Taiwan Food and Drug Administration (TFDA)

October 11, 2018 Tokyo

6th Joint Conference of Taiwan and Japan on Medical Products Regulation

2

Content

• Overview of TFDA’s major international activities in:

– AHWP (Work Group 2 – Pre-market: IVD)

– APEC (LSIF-RHSC)

• including general introduction, participation outcomes, future work plans and strategies

• in relation to the above organizations

3

Bahrain

AHWP (1/2)

Kazakhstan Mongolia

Totally, 31 Member Economies In Asia, Africa, Middle-East, Latin America

United Arab Emirates

Oman

Zimbabwe Kenya

4

AHWP (2/2)

Asian Harmonization Working Party (AHWP) is established as

a non-profit organization.

Its goals are to study and recommend ways to harmonize

medical device regulations in the Asian and other regions and

to work in coordination with the Global Harmonization Task

Force, APEC and other related international organizations

aiming at establishing harmonized requirements, procedures

and standards.

The Working Party is a group of experts from the medical

device regulatory authorities and the medical device industry.

Membership is open to those representatives from the Asian

and other regions that support the above stated goals.

5

Participation in AHWP

AHWP TC WG2 – Pre-market: IVDD

TFDA holds the WG2 Chair position for 3 consecutive

terms (starting from 2012 till present)

TFDA organizes 4~5 face-to-face and teleconference

working meetings per year to discuss and conduct

WG2 work plan

6

Outcomes in AHWP (1/2)

AHWP guidance/reference documents developed and endorsed by AHWP

In 2012-2014 :

– AHWP/WG1a/F001:2013 AHWP Regulatory Framework for IVD

Medical Devices

– AHWP/WG1a/F002:2013 Essential Principles of Safety and

Performance of IVD Medical Devices

– AHWP/WG1a/F004:2013 Comparison between the GHTF Summary

Technical Documentation (STED) formats for Medical Devices and

In Vitro Diagnostic Medical Devices and the Common Submission

Dossier Template (CSDT) format

– AHWP/WG2-WG8/F002:2014 Role of Standards in the Assessment

of Medical Devices

– AHWP/WG2/F001:2014 Comparison between CSDT and STED

IVDDs

7

Outcomes in AHWP (2/2)

AHWP guidance/reference documents developed and endorsed by AHWP

In 2015-2017 :

– AHWP/WG2-WG1/F001:2016 Definition of the Terms “Medical

Device” and “In Vitro Diagnostic (IVD) Medical Device”

– AHWP/WG2/F003:2016 Submission Dossier for Demonstrating

Conformity to the Essential Principles of Safety and Performance of

In Vitro Diagnostic Medical Devices

– AHWP/WG2/F002:2016 Principles of Conformity Assessment for In

Vitro Diagnostic (IVD) Medical Devices

– AHWP/WG2/F001:2016 Principles of In Vitro Diagnostic (IVD)

Medical Devices Classification

– AHWP/WG2/WD001:2017 Guidance for Additional Considerations

to Support Conformity Assessment of Companion In Vitro

Diagnostic Medical Devices

8

Future Strategy & Work Plan in AHWP

Strategy

Work plan – Develop AHWP guidance documents

Labelling for in vitro diagnostic medical devices (IVDs)

Change management for medical devices (including IVDs)

Approval of reagent for instrument family

– Collaborate with international organizations Recommendations provided to WHO IVD PQ program guidance

Representation to participate in ISO/TC 212/WG3 technical meetings

(2018-2020)

Develop AHWP guidance documents

Provide recommendations to implement regulatory framework

Participate in international organization collaborations

Expand contributions in AHWP to the globe

9

APEC (1/3)

21 member economies

Source: http://www.egeda.ewg.apec.org/egeda/about

10

17 fora

APEC (2/3)

Leaders Meeting

APEC Business Advisor Council

Ministerial Meeting Sectoral Ministerial

Meetings

Senior Officials Meeting (SOM)

Committee on Trade and Investment (CTI)

Budget and Management

Committee (BMC)

Economic Committee

(EC)

SOM Steering Committee on ECOTECH (SCE)

Life Sciences and Innovation Forum

(LSIF)

APEC Secretariat

Policy Level Working Level

APEC Structure:

Regulatory Harmonization Steering Committee(RHSC)

11

APEC (3/3)

As of August 2018, the current list of “Priority Work Areas” (PWAs) approved by APEC LSIF-RHSC is as follows:

Multi-regional Clinical Trials (MRCT), merged with Good

Clinical Practices (GCP) Inspection

Medical Product Quality and Supply Chain Integrity

Biotherapeutics (Biotechnological Products)

Good Registration Management (Good Review Practices

(GRevP), merged with Good Submission Practices)

Pharmacovigilance

Advanced Therapies

Medical Devices

12

Participation in APEC LSIF-RHSC

Roles in RHSC

• GRM roadmap co-champion

• GRM CoE hosting institution

13

Current Outcomes & Future Strategy in RHSC

14

Future Work Plan in RHSC (1/2)

On 2018/9/3, RHSC circulated a draft on Medical Device PWA roadmap:

Lead Economies

– USA

– Japan

– Korea

Structure

– Co-Champions

– Sub-Champions

– Centers of Excellence (CoE)

Convergence Target

– Premarket

– Quality Management System (QMS)

– Postmarket

15

Future Work Plan in RHSC (2/2)

Look into the possibility of becoming a sub-

champion/CoE under Medical Device PWA

Work with co-champions (U.S. FDA, Japan PMDA, and

Korea MFDS) for endorsement of potential topic

Collaborate with interested partners to carry out

capacity training for APEC member economies

Help to advance RHSC’s vision of achieving regulatory

convergence for medical products by 2020

TFDA plans to support RHSC’s Medical Device PWA:

16

Thank You

16