Regional Update ASEAN PPWG

Transcription

1 Regional Update ASEAN PPWG by Yuppadee JAVROONGRIT, Ph.D. Co-Chair of ACCSQ/PPWG, ASEAN ThaiFDA, Thailand The ICH-Global Cooperation Group Meeting The Hilton San Diego Bay Front Hotel, San Diego, CA, USA 13 November

2 ASEAN PPWG & ICH Q7 not directly adopted the ICH-Q7 ASEAN has adopted International GMP Std : i.e. - PIC/s Code of GMP - WHO-latest version Code of GMP Therefore, ASEAN comply to PIC/s GMP of API Training :- - topic: Starting Material & Packaging Material ( ) - under ASEAN-Australia-NewZealand FTA Economic Coop. Work Programme (AANZFTA ECWP) 2

3 Outcome (1) related to the ICH/GCG The 19 th PPWG Meeting 2-6 July 2012 Bangkok, Thailand 3

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5 Outcome (1-1) participants ~350 from 9 countries (Regulators + Industries) official opening by Honourable H.E.DeputyMinister Dr.Surawit KONSOMBOON, MOPH, Thailand back to back activities : - Seminar on QbD Forum and the Biosimilar Regulation - PPWG Heads of Delegations (HoDs) Meeting ; - 1 st Meeting of the Joint Sectoral Committee (JSC) of the ASEAN Sectoral MRA on GMP Inspection of Manufacturers of Medicinal Products ; - Technical Working Group (TWG) Meetings on ACTR/ACTD- Quality Guidelines, BA/BE Guidelines, Safety and Efficacy Guidelines, Variation guideline and Biologics harmonization; and - 14 th Implementation Working Group (IWG) Meeting 5

6 Outcome (1-2) The B/B Seminar (1) The QbD Forum: - ICH Q8/Q9/Q10/Q11) - Speakers ; o o o o o Chi-wan CHEN, Ph.D. (Executive Director, Global CMC, Pfizer Inc., USA) Moheb NASR, Ph.D. (Vice President, CMC Regulatory Strategy, GSK,USA) Eric AHUJA, Ph.D. (Sr. Director, Commercialization and Supply Analytical Global Science Technology and Commercialization, Merck and Co, Inc., USA) Mr.Steven MENDIVIL (Executive Director, International Quality, External Affairs, Amgen, USA) Tim WATSON, Ph.D. (Research Fellow, Global CMC, Pfizer Inc, USA) 6

7 Outcome (1-3) The B/B Seminar (2) Biosimilar Regulation : - The Biosimilar Regulation: Rationale and Regulatory Requirements - Speaker ; o Dr.Thomas SCHREITMUELLER (Member of IFPMA Biotherapeutic Working Group, Head Regulatory Policy and Strategy Biologics, F.Hoffmann-La Roche Ltd. Basel, SWITZERLAND) Many thanks PhRMA & IFPMA, all Speakers for all Supports Dr.CHEN and Dr.SCHREITMUELLER for great Coordination!!! 7

8 Outcome (1-4) Important Outcome (1) Updating the Safety & Efficacy Technical gls. : - agreed to the revised criteria used to adopt ICH Safety Gls. for ASEAN and to re-visit gls. previously adopted at the 9 th PPWG Meeting - agreed in principle to adopt ICH Efficacy Technical Gls. which were previously adopted (revised) and new gls E2C(R1), E2F, E14, E15 and E16 as reference gls. for ASEAN & agreed to endorse the revised criteria used for adoption of ICH Efficacy gls. for ASEAN 8

9 Outcome (1-5) Important Outcome (2) Next PPWG Meetings : - Special HOD PPWG Meeting Brunei Darussalam -20 th PPWG Meeting Indonesia 9

10 Outcome (1-6) and ICH-GCG (1) GCG Update to the 19 th PPWG by PPWG Co-Chair presented Topics : - The GCG Meetings on Jun.12-Fukuoka Meeting o Topics o Rpt. - Opportunity on Training o The Training (using Form-GCG53F) o Self-learning (on ICH 15 Past Training Materials -Attachment) o The Webinar (at step 2 & 4 of the Technical guideline(s)) 10

11 Outcome (1-7) and ICH-GCG (2) - Recommendation to 19 th PPWG o To note the GCG Update presented by Co-Chair o To note the Opportunity on Training from ICH-GCG ( o To consider benefit of the Opportunity on Training request/join the Training proceed the self-learning participate the Webinar 11

12 Outcome (1-8) and ICH-GCG (3) the 19 th PPWG...(1) noted update of ICH-GCG recommended ASEAN Member States to note and consider participation in the Training/ Self-learning/ Webinars o Training : Member wishing to request for trainings provided by the ICH-GCG requested to submit their request to the Chair and Co-Chair of PPWG at least three months in advance using the ICH-GCG Form. all requests for training will be acknowledged by the Chair of PPWG and the Co-chair will coordinate with the ICH-GCG. 12

13 Outcome (1-9) and ICH-GCG (4) the 19 th PPWG...(2) o Self -Learning : The Meeting noted that currently 15 training materials have been uploaded in the ICH website ( encouraged Member States to participate in the self-learning from the pool of training materials available in the website 13

14 Outcome (1-10) and ICH-GCG (5) the 19 th PPWG...(3) o Webinar : The Meeting requested Member States who are interested to participate should notify the Co-Chair of the PPWG upon informing of the event upon coordination by the Co-Chair of the PPWG, the ICH secretariat will communicate further; i.e. confirm the dates and time, instructions for participation, and provide Webinar materials 14

15 Outcome (2) related to the ICH/GCG ASEAN PPWG - Activities 15

16 Outcome (2-1) attending the ICH-GCG Webinar : - more participation of the ASEAN Countries - mix of Participants: Academic, Industry, and DRA - in 2 Webinarso o E14 & E14 Q&A Q11 Many thanks to ICH/ICH-GCG Secretariat on the opportunity, warm welcome and great support!!! 16

17 Recommendation to the GCG to note progress of the ASEAN PPWG related to the ICH/ICH-GCG to note PPWG procedure on requesting Training(s) from ICH/ICH-GCG to continue Support ASEAN PPWG : participating the future Webinar(s) - for future Requests on the Training(s) 17

18 Thank You 18