Mission

The AHC was established in order to contribute to trade facilitation and economic integration in the APEC region. AHC s mission for that includes

1 Facilitate regulatory convergence in the region and beyond

2 Enhance quality safety and ef�cacy of medical products

3 Promote collaboration and information sharing among APEC members

4 Support access to the best practices and international guidelines

AHC Director

Is responsible for overseeing AHC s activities

and events and leading coordination among

LSIF RHSC AHC Secretariat and AHC Advisory

Board. The AHC Director is performed by Director

General of the NIFDS the MFDS.

AHC Advisory Board

Is responsible for providing technical input

and professional expertise on the strategic

direction of AHC s activities, and assistance

for development of training module and inviting

appropriate experts.

AHC Secretariat

Is responsible for administrative works and

serves as a focal contact point of AHC. The AHC

Secretariat is currently supported by the Korea

Pharmaceutical and Bio-Pharma Manufacturers

Association(KPBMA)

Organization

APEC BusinessAdvisory Council

MinisterialMeeting

Sectoral MinisterialMeeting

APEC Harmonization Center

National Institute of Food and Drug Safety EvaluationMinistry of Food and Drug Safety 187 Osongsaengmyeong 2-ro Osong-eup Heungdeok-gu Cheongju-si Chungcheongbuk-do 28159 Republic of KoreaTel. +82 43 719 2874~6 / e-mail. apec-ahc@korea.krSecretariat Tel. +82 2 6301 2158 or 2162~3 / e-mail. ahckorea@kpbma.or.kr

APECHarmonization

Center

The AHC in partnership with the APEC Regulatory Harmonization Steering Committee(RHSC), is operated under the auspices of the APEC Life Sciences Innovation Forum(LSIF) in order to provide a platform for regulatory priorities among APEC member economies. The AHC is operated and supported by the National Institute of Food and Drug Safety Evaluation(NIFDS), the Ministry of Food and Drug Safety(MFDS), Republic of Korea .

APEC LSIF

APEC RHSC APEC Harmonization Center

APEC Leaders' Meeting

Senior Of�cials Meeting

Senior FinanceOf�cials Meeting

Committee onTrade &

Investment

Budget &Management

Committee

EconomicCommittee

SOM SteeringCommittee on

ECOTECH

edu.apec-ahc.org

Workshop Website

e-Learning Center

Research

01 02

03

04

The AHC has hosted 37 workshops where approximately 9 100 regulators and industry participants were provided with training and discussed regulatory harmonization. AHC s support for participation of 11 travel eligible economies 311 trainees has significantly contributed to the regulatory harmonization of medical products in the region

The APEC Harmonization Center AHC was established in 2009 with the endorsement of the APEC ministerial-level talks and summit as an official and permanent organization specialized in training. The AHC is in pursuit of APEC s trade facilitation and regional economic integration by promoting a higher level of international regulatory harmonization in the region.

APEC Ministers speci�cally endorsed the AHC in the annual Ministerial Joint Statement“Recalling our commitment to promoting regulatory reform and harmonization, we welcomed and endorsed the establishment of the APEC LSIF Harmonization Center in Seoul as a key step forward."

Founded the AHC and organized the �rst AHC s Workshop

Appointed as the representative of APEC to ICH meetings

Renewed the website of the APEC Harmonization Center

Initiated co-development of ICH E2 guideline online training program with ICH

Became a coordinator of APEC Centers of Excellence CoEs

Completed the development of AHC-ICH E2 Guideline training programLaunched AHC e-Learning Center and opened training services

Chaired the �rst APEC RHSC CoE Director s Meeting

Hosted/Co-hosted AHC Workshop and training 37 times

Many training resources are available at AHC s website to ensure an easy access to various training materials and achievements of AHC s efforts for regulatory harmonization. The AHC provides not only workshop video clips and presentation materials but also AHC s research and annual reports.

In 2016 the AHC opened e-Learning Center to support more efficient means of capacity building in a wider area.

The AHC and the International Council for Harmonisation ICH developed ICH guideline E2 Pharmacovigilance training programs together. Following that the AHC also developed ICH QbD guideline

ICH Q8 Q9 and Q10 training programs and Biotherapeutics online course which started to be provided since 2017. The AHC will continue to expand training programs based on priorities in the APEC region.

The AHC conducts various research projects in order to identify areas where regulatory harmonization is needed and take actions in response to the needs. For example the AHC has published reports on drug approval system of 21 APEC member economies since 2015 available on AHC website . A survey on ICH guideline implementation among APEC member economies was conducted in 2014 and the survey report was published and is also available on the website www.apec-ahc.org .

1 06. 2009 Inauguration of the AHC and Multi-Regional Clinical Trial Workshop

2 09. 2009 Biotherapeutics Workshop Biosimilar

3 11. 2009 Pharmaceutical GMP Validation Workshop

4 05. 2010 Globalization of the Pharmaceutical Supply Chain Workshop

5 09. 2010 Multi-Regional Clinical Trial Workshop

6 11. 2010 Clinical Evidence on Medical Devices Workshop

7 04. 2011 Asia Regulatory Conference

8 07. 2011 Medical Devices Workshop Implementation of GHTF Documents

9 10. 2011 AHC-ICH Of�cial Integrated Implementation Training Workshop for ICH Q8 Q9 and Q10

10 11. 2011 Multi-Regional Clinical Trial Workshop

11 04. 2012 Biotherapeutics Workshop Biosimilar

12 08. 2012 AHC and RHSC Awareness Workshop

13 10. 2012 Pharmacovigilance Workshop

14 11. 2012 APEC-AHWP Joint Workshop on Medical Device Combination Products

15 05. 2013 Medical Products Safety and Public Awareness and Establishing SPOCs Workshop

16 09. 2013 Biotherapeutics Workshop

17 11. 2013 Pharmacovigilance Workshop

18 12. 2013 AHC and RHSC Awareness Workshop

19 05. 2014 Multi-Regional Clinical Trials and Good Clinical Practice Inspection Workshop

20 05. 2014 Biotherapeutics Workshop Progress to Convergence

21 07. 2014 AHC-HSA Cell and Tissue based Therapeutic Product Workshop

22 11. 2014 AHC-AHWP Joint Workshop Medical Devices

23 01. 2015 Training Program on Medical Product and Supply Chain Integrity

24 07. 2015 Biotherapeutics Workshop

25 08. 2015 Training Program on Medical Product and Supply Chain Integrity

26 09. 2015 Pharmacovigilance Workshop and Training

27 11. 2015 AHC Generic Drugs Workshop

28 02. 2016 Training Program on Medical Product Integrity and Supply Chain Security

29 09. 2016 Pharmacovigilance and Medical Device Vigilance Workshop

30 09. 2016 Biotherapeutics CoE Pilot Training Northeastern University

31 11. 2016 Biotherapeutics CoE Pilot Training Seoul National University

32 11. 2016 Good Registration Management CoE Pilot Training RAPS/TFDA

33 03. 2017 CoE Pilot Program for Product Quality and Supply Chain USPC

34 06. 2017 CoE for GDPs and Product Security Pilot Program UTHSC

35 07. 2017 CoE Workshop on Advanced Therapies Duke-NUS

36 09. 2017 Pharmacovigilance and Medical Device Vigilance Workshop

37 11. 2017 AHC Biopharmaceutical Pre-CoE Training

AHC Activities In cooperation with the international organizations including LSIF RHSC WHO ICH and IPRP* the AHC is focusing on capacity building and regulatory harmonization based on international guidelines

www.apec-ahc.org

11. 2008

06. 2009

02. 2016

06. 2012

08. 2016

12. 2013

05. 2015

08. 2017

~12. 2017

History

* World Health Organization WHO International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ICH International Pharmaceutical Regulators Programme IPRP