AHWP Technical Committee

1
AHWP Technical Committee Meeting (TC-8)
Kuala Lumpur, Malaysia 5 March 2008
2
Asian Harmonization Working Party
Agenda of Meeting
Technical Committee

• Welcome and Introduction
• Update on TC and AHWP-GHTF Meeting
• STG (Nomenclature) Update
• Tea Break and Photo Session
• WG01 CSTD Update
• WG01a IVDD Update
• WG02 SADSNCAR Update
• WG06 Regulatory Training Update
• AHWP TC Way Forward
• Any Other Business

3
Asian Harmonization Working Party
TC Core Team (as of March 08)
Technical Committee

• Mr. Albert POON - Chair
• Mr. Alfred KWEK - Co-chair
• Ms. Daphne YEH - Co-chair
• Members nominated/ recruited (NRWG01RP)
• WGs (3 active 3 being formed)
• STG (nomenclature)

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Asian Harmonization Working Party
Recent Meetings and Participants
Technical Committee
44 delegates attended TC6 Meeting (25-27 April
2007 in Hong Kong, China)
58 delegates attended TC7 Meeting (24 October
2007 in Chengdu, China)
44 delegates attended TC8 WG Meeting (3 March
2008 in Kuala Lumpur, Malaysia)
40 attended TC Report-to-AHWP Meeting (4 March
2008 in Kuala Lumpur, Malaysia)
Today (5 March 2008) TC8 Main Meeting
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Asian Harmonization Working Party
TC Task Meetings and Activities
Technical Committee

• 6-7 Sept 2001 TC1 in KL, Malaysia
• 2002 TC assisted AHWP Survey on Pre-market
  Requirements STED
• 12-13 Dec 2002 TC2 in Bangkok
• 29-30 Apr 2004 TC3 in Chinese Taipei (WG01)
• 8 Dec 2004 WG01 1st Meeting, Langkawi

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Asian Harmonization Working Party
TC Task Meetings and Activities
Technical Committee

• 17 Jun 2005 WG01 2nd Meeting, Bangkok
• (TC4 with election of office bearers)
• 14 Sept 2006 TC5 Meeting in Seoul, Korea
• 25-27 April 2007 TC6 Meeting in Hong Kong
• 24 Oct 2007 TC7 Meeting in Chengdu, China
• 3-5 March 2008 TC8 Meeting in Kuala Lumpur,
  Malaysia

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Asian Harmonization Working Party
Achievements Update
Technical Committee

• Training Workshops
• 2002 AHWP Survey on Pre-market requirements and
  STED
• WG01 Comparative Study on MD requirements in Asia
  (STED Matrix)
• Common Submission Dossier Template (CSDT)
• Formation of WGs
• PMS, SADS and NCAR Training
• Proposal for Regulatory Training
• Review on Nomenclature Systems

8
Asian Harmonization Working Party
Update on TC Structure
Technical Committee
TC Office Bearers (3)
OB
Resource Persons WG01 Members 105 embedded
in WGs and STG(N)
WGs RP
NR
Nominated Rep of Member Economies (20-30)
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Asian Harmonization Working Party
Work Groups and TC Structure
Technical Committee
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Asian Harmonization Working Party
TC Work Groups
Technical Committee

• WG01 Pre-market Submission and CSDT (2413
  Members now)
• Chair Alfred Kwek, HSA Singapore
• Co-Chair Daphne Yeh, Philips Chinese Taipei
• IVDD Chair Dr.Abdul Rahman Al Gifari, Saudi
  Arabia
• Co-Chair Jeffery Chern, ITRI, Chinese
  Taipei
• WG02 Post Market Surveillance and SADS (28
  members now)
• Chair Mark Lau, DOH Hong Kong
• Co-Chair Miang Tanakasemsub, BL Hong Kong

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Asian Harmonization Working Party
TC Work Groups
Technical Committee

• WG03 Quality Management System (to be
  developed) (4)
• WG04 Quality System Audits (to be developed)
  (3)
• WG05 Clinical Evidence Requirements (to be
  developed) (6)

• WG06 Capacity Building and Regulatory Training
  
• (20 members now)
• Chair Albert POON, EMSD Hong Kong
• Co-Chair Jack WONG, BSI Hong Kong

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Asian Harmonization Working Party
TC Work Groups
Technical Committee

• STG Special Task Group on Nomenclature (newly
  formed)
• ( 7 members now)

Chair YAN Liang, SFDA, China Co-Chair Jennifer
Mak, MDCO, DH, Hong Kong
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Asian Harmonization Working Party
Milestone Enhancement on TC structure

• Nomination of representatives (NR) from member
  economies are on-going and would be kept updated
  to the TC webpage.
• Anticipated to complete update of TC membership
  by end of year.
• Recruitment of resource persons (RP) also
  on-going by invitation or by voluntary service

Technical Committee

• 4. Formalization of Work Group structure with
  AHWP. (Done)
• 5. Recruitment for WG members on-going.
• WG03 05 to be developed in time as required
• STG(N) formed with endorsement from AHWP

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Asian Harmonization Working Party
Items of Interest from AHWP GHTF Joint Meeting
Technical Committee
Held in afternoon of March 4, 2008 Communication
/ Participation between GHTF SG and AHWP TC
WG APEC Proposal for Medical Device
Delegation GMDN and Nomenclature issue Training
and Training Support CSDT Brief Update SAD System
Update
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Asian Harmonization Working Party
TC8 Agenda Continued
Technical Committee
STG (Nomenclature) Update
Tea Break and Photo Session
WG01 CSTD Update WG01a IVDD Update WG02
SADSNCAR Update WG06 Regulatory Training Update
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Asian Harmonization Working Party
TC Way Forward - Projects And Plans
Technical Committee

• Reviewing the issue on CSDT for common submission
  purpose vs harmonization (WG01)
• Incorporating IVDD extension from CSDT
• Continuing the good progress on WG02 (SADS and
  NCAR)
• Quality System Requirements such as QSR and ISO
  13485 (WG03 04) to be addressed

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Asian Harmonization Working Party
TC Way Forward - Projects And Plans
Technical Committee

• Clinical Evidence Requirements to be addressed
  (WG05)
• Formalizing framework for regulatory training and
  launch web-based course in 2008 (WG06)
• Reviewing nomenclature system for AHWP member
  economies
• Assisting AHWP in review of ToR/Constitution and
  longer term secretariat support.

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Asian Harmonization Working Party
TC Objectives
Technical Committee

• To execute, at TC and WG levels, the aims and
  objectives of AHWP and to assist AHWP member
  economies to develop their respective regulatory
  systems and requirements on harmonization
  approach.
• To work in line with SGs of GHTF, APEC and
  various competent authorities towards goal of
  harmonization where necessary.
• 3. To assist the region in knowledge sharing,
  and dissemination capacity building and
  development of regulatory professionals and their
  recognition in the region.

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Asian Harmonization Working Party
Any Other Business
Technical Committee

• TCs Appeal for
• Member Economies to update nomination of
  representatives to TC
• Volunteering Resource Persons to join TC and WGs
• Thank You