AHC Mission

The AHC was established to provide a sustained way of advancing APEC's trade facilitation and regional economic integration :

1 By facilitating regulatory convergence in the region and beyond2 By enhancing quality, safety and ef�cacy of medicinal products3 By promoting collaborative actions and information sharing4 By supporting access to the best practices and international

guidelines

AHC DirectorIs responsible for overseeing activities and events and leading coordination among LSIF, RHSC, AHC Secretariat, and AHC Advisory Board. The Director of AHC is performed by Director General of the National Institute of Food and Drug Safety Evaluation(NIFDS), the Ministry of Food and Drug Safety(MFDS), Korea.

AHC Advisory BoardIs responsible for providing technical input and professional expertise on the strategic direction of AHC events for developing training modules and securing appropriate trainers to be used as resources for strengthening the AHC and its speci�c projects.

AHC SecretariatIs responsible for administrative point of contact and organization of the AHC's day-to-day activities. The Secretary General is an overseer of the Secretariat's activities including international cooperation, and assists the AHC Director. Duties of AHC Secretariat are performed by the Korea Pharmaceutical Manufacturers Association(KPMA).

AHC Mission&Organization

AHC Organization

APEC BusinessAdvisory Council

MinisterialMeeting

Sectoral MinisterialMeeting

APEC Leaders' Meeting

Senior Of�cials' Meeting

Senior FinanceOf�cials' Meeting

Committee onTrade &

Investment

Budget &Management

Committee

EconomicCommittee

SOM SteeringCommittee on

ECOTECH

APEC Harmonization Center

National Institute of Food and Drug Safety Evaluation,

Ministry of Food and Drug Safety, 187 Osongsaengmyeong 2-ro, Osong-eup, Cheongju-si, Chungcheongbuk-do, 28159, Republic of KoreaTel. +82-43-719-2874~9 / e-mail. apec-ahc@korea.kr

AEPC Harmonization Center Secretariat

Korea Pharmaceutical Manufacturers Association161 Hyoryeong-ro, Seocho-gu, Seoul, 06666, Republic of KoreaTel. +82-2-6301-2158, 2162~3 / e-mail. ahckorea@kpma.or.kr

Activities and Challenges

A P E C H A R M O N I Z A T I O N C E N T E R

A P E CHarmonization C e n t e r

The AHC, in partnership with APEC Regulatory Harmonization Steering Committee(RHSC), is operated under aegis of APEC Life Sciences Innovation Forum(LSIF) in order to provide 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), Korea.

APEC LSIF

APECHarmonization Center

AHC Director(NIFDS, MFDS)

AHC(NIFDS, MFDS)

AHCAdvisory Board

AHC Secretariat(KPMA)

edu.apec-ahc.org

AHC Workshop AHC Website

AHC e-Learning Center

AHC Research

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The AHC has hosted 28 workshops, where approximately 8,000 regulators and industry participants were provided with training and discussed ways to achieve regulatory harmonization. By supporting participation of 11 APEC travel eligible economies (215 trainees) for training, the AHC has contributed to the regulatory harmonization in the APEC region.

The APEC Harmonization Center(AHC) was established in 2009 after the endorsement of the APEC ministerial-level talks and summit as an of�cial 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 APEC region.

Ministers and officials at the LSIF recommended APEC Leaders to endorse the "capacity building for the harmonization of standards and regulatory practices for medical products and services according to international best practices where the need is most pressing and obstacles are the greatest"

Korea proposed the establishment of the AHC at the LSIF meeting in Peru.

APEC Ministers specifically 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."

The AHC was established in the MFDS.

To ensure easy access to various training materials and achievements of regulatory harmonization that the AHC is working on, related data are available at the AHC website. The AHC provides not only workshop video clips and presentation materials, but also AHC research reports and annual reports.

In 2016, the AHC opened e-Learning Center to ensure capacity building of regulators and expansion of regulatory harmonization training opportunities in the APEC region.

The AHC has proposed a joint development of ICH guideline training program to the International Council on Harmonization (ICH) and is jointly developing online training program under the agreement with the ICH. After conducting pilot training program for ICH pharmacovigilance guidelines(ICH E2 series), the AHC is now planning to expand the program to a number of topics in the future.

The AHC conducts various research projects in order to pioneer areas in need of regulatory harmonization and to seek measures. On the basis of the research on pharmaceutical regulatory framework of APEC economies, the AHC plans to publish regulatory requirements of each economy, through its website which will be continuously updated in the form of report. Moreover, a survey on ICH guideline implementation status in each APEC economy and its priority training areas was conducted by the AHC and the result reports are also available at the website. The AHC will continue its efforts to achieve regulatory harmonization through research activity.

1 06. 2009 Inauguration of the AHC & Multi-Regional Clinical Trial Workshop2 09. 2009 Biotherapeutics Workshop: Biosimilar3 11. 2009 Pharmaceutical GMP Validation Workshop4 05. 2010 Globalization of the Pharmaceutical Supply Chain Workshop5 09. 2010 Multi-Regional Clinical Trial Workshop6 11. 2010 Clinical Evidence on Medical Devices Workshop7 04. 2011 Asia Regulatory Conference8 07. 2011 Medical Devices Workshop: Implementation of GHTF Documents9 10. 2011 AHC-ICH Of�cial Integrated Implementation Training Workshop for ICH Q8 & Q1010 11. 2011 Multi-Regional Clinical Trial Workshop11 04. 2012 Biotherapeutics Workshop: Biosimilar12 08. 2012 AHC and RHSC Awareness Workshop13 10. 2012 Pharmacovigilance Workshop14 11. 2012 APEC-AHC-AHWP Joint Workshop on Medical Device Combination Products15 05. 2013 Medical Products Safety and Public Awareness and Establishing SPOCS Workshop16 09. 2013 Biotherapeutics Workshop17 11. 2013 Pharmacovigilance Workshop18 12. 2013 AHC and RHSC Awareness Workshop19 05. 2014 Multi-Regional Clinical Trials and Good Clinical Practice Inspection Workshop20 05. 2014 Biotherapeutics Workshop: Progress to Convergence21 07. 2014 AHC-HSA Cell and Tissue based Therapeutic Product Workshop22 11. 2014 AHC-AHWP Joint Workshop (Medical Devices)

23 01. 2015 Training Program on Medical Product and Supply Chain Integrity 24 07. 2015 Biotherapeutics Workshop25 08. 2015 Training Program on Medical Product and Supply Chain Integrity 26 09. 2015 Pharmacovigilance Workshop and Training27 11. 2015 AHC-NIFDS Generic Drug Workshop28 02. 2016 Training Program on Medical Product Integrity and Supply Chain Security

AHC ActivitiesAHC History In cooperation with the international organizations including LISF, RHSC, WHO, IFPMA, ICH, and IGDRP, the AHC is working to enhance capacity building in the health industry and harmonize with international regulations by providing various training for APEC regulators and industries in the medical product area.

www.apec-ahc.org

09. 2005

08. 2008

11. 2008

06. 2009

AHC History