Proposal Submission

🌐 Collaboration Proposal Submission
Submit Your Proposal to Collaborate with the Global Harmonization Center (GHC)


The Global Harmonization Center (GHC), established under the Ministry of Food and Drug Safety (MFDS) of the Republic of Korea, serves as a regulatory education center supporting authorities in the field of medicinal product regulation and promoting international cooperation for global regulatory convergence.

Building on the experience of the former APEC Harmonization Center (AHC), GHC now operates independently from the APEC governance structure, with a focus on MFDS-led, practice-oriented training and cooperation..

Organizations or individuals interested in collaborating with GHC—whether through international partnerships, training program development, or the organization of seminars and workshops—are invited to submit a proposal using the online form below.

All proposals will be reviewed internally, and selected applicants will be contacted individually.

📌 Areas of Potential Collaboration
- Development of training programs and recommendation of instructors
- Co-hosting of domestic and international workshops
- Proposals for cooperation with international regulatory agencies
- Other suggestions aligned with GHC’s objectives

📄 How to Submit
Click the [Submit Proposal] button below to access the online form.
Complete the required fields and click [Submit] to send your proposal.

Contact: ghcteam@korea.kr
     SOP Financial Guidance
Submit Proposal
No Title Name Secret Date State
2024 Application
8 [SAMPLE] Regulatory Convergence APEC Harmonization Center 2024.01.01 Virtual
7 Navigating Digital Health Product Development in Southeast Asia Amid Evolving FDA Regulations Leena Suntornsuk 2024.01.01 In-person
6 Navigating Digital Health Product Development in Southeast Asia Amid Evolving FDA Regulations Leena Suntornsuk Secret 2024.01.01 In-person
5 Promoting the adoption of rigorous regulatory pathways for Biosimilars Michael Schmitz 2024.01.01 In-person
4 Confronting an Epidemic of Drug Shortages: Incentivizing quality for supply chain resilience Michael Schmitz 2024.01.01 In-person
3 Disruption in the supply of pharmaceutical raw materials and inferior quality medicines during the pandemic Lessons learnt and measures moving forward P T Thomas 2024.01.01 In-person
2 Disruption in the supply of pharmaceutical raw materials and inferior quality medicines during the pandemic Lessons learnt and measures moving forward P T Thomas 2024.01.01 In-person
1 Introduction to Supply Chain Integrity of medical products Andy Lee 2024.01.01 In-person
No Title Name Secret Date State
2023 Application
7 Virtual workshop on Multi-Regional Clinical Trials MRCT Roman Ivanov 2023.01.30 Virtual
6 Virtual workshop on Biotherapeutics Dr Roman Ivanov 2023.01.29 Virtual
5 Virtual Workshop on regulatory requirements for advanced therapy medicinal products Dr Roman Ivanov 2023.01.29 Virtual
4 Virtual Workshop On Post Approval Change Management Protocols PACMP Ms Nik Shamsiah Nik Salleh 2023.01.27 Virtual
3 Virtual Workshop On Vaccine Delivery Technology Dr Azizah Abdul Ghani 2023.01.27 Virtual
2 Training of Trainers for MyUBAT users Siti Fauziah Abu 2023.01.27 Virtual
1 [SAMPLE] Regulatory Convergence APEC Harmonization Center 2023.01.10 Virtual
No Title Name Secret Date State
2022 Application
5 The APEC Rare Disease Network proposes a joint AHC-RDN Workshop on Accelerating Regulatory Convergence for Orphan Medical Products Topic areas could include but are not limited to: Regulatory definitions of RD, OMP, and unmet medical need; Pre-licensing support including scientific and regulatory advice; Expeditedaccelerated development, registration, and approval pathways, including reliance; Innovative clinical trial designs, methods, and ethics approvals for small patient populations; Use of real-world evidence in the review of OMPs and in post-authorization activities; Local clinical trial waivers and use of international clinical trial data for OMPs to address small populations; Exemptions of requirements for local manufacturing, sampling, import testing, and local GMP certificates; Tax credits andor fee waivers for development activities related to RDs and OMPs; and, Establishment of a specific and enforceable market exclusivity period for OMPs Matthew Bellgard 2021.12.02 In-person
4 In partnership with AHC, AdvaMed as RHSC Medical Device Industry Coalition Co-Coordinator proposes convening an “APEC LSIF RHSC Workshop on Global Regulatory Convergence for Medical Devices”, which: 1 builds on recommendations from Days 3 and 4 of the “APEC LSIF RHSC Roundtable Dialogue on Post-Pandemic Regulatory Innovation & Convergence for Medical Devices” 3-4 November 2021 which examined the regulatory flexibilities and extraordinary measures applied for medical devices during the pandemic by APEC medical device regulatory authorities; 2 helps implement new and reaffirmed commitments by the APEC High‐Level Meeting on Health and Economy Joint Statement 24 August 2021 which acknowledged the value of regulatory convergence and reliance for medical product review and approval procedures in ensuring the safety and availability of medical products and other health technologies, including those essential to the COVID-19 response; and 3 helps implement new and reaffirmed commitments by the APEC Ministers Responsible for Trade in their Joint Statement 5 June 2021 to create an enabling, inclusive and non-discriminatory digital economy that fosters the application of new technologies The “APEC LSIF RHSC Workshop on Global Regulatory Convergence for Medical Devices” could focus on opportunities for convergence including but not limited to: 1 Implementing agile premarket pathways; 2 Developing international guidelines on a common emergency use pathway; 3 Adopting policies that enable alternative sources of evidence in medical device regulatory review and approval; 4 Facilitating the adoption of state-of-the-art digital technologies, such as those enabling remote inspections and audits, electronic document submissions, e-labeling, and virtualhybrid meetings between regulators and sponsors; 5 Enabling public-private partnerships Janet Trunzo Secret 2021.11.30 Virtual
3 In partnership with AHC, PhRMA as RHSC Research-Based Industry Coalition Co-Coordinator, proposes jointly convening the “2nd APEC Roundtable Dialogue on Post-Pandemic Regulatory Innovation & Convergence for Vaccines and Therapeutics”, which: 1 builds on the 1st Virtual APEC Roundtable Dialogue on Post-Pandemic Regulatory Innovation & Convergence on Vaccines and Therapeutics in November 2021; 2 helps implement commitments by the LSIF in its Statement on COVID-19 12 June 2020 to continue advancing regulatory convergence and building skilled human capacity needed to effectively and efficiently respond to future pandemics; and, 3 helps implement commitments by the APEC Ministers Responsible for Trade in its Statement on COVID-19 5 May 2020 to intensify efforts to make global supply chains more resilient and less vulnerable to shocks 4 helps implement commitments set forth by the 2021 APEC Ministerial Meeting 9 November 2021 to accelerate access to safe and effective vaccines, diagnostics, and therapeutics for COVID-19 The 2nd APEC Roundtable Dialogue on Post-Pandemic Regulatory Innovation & Convergence for Vaccines and Therapeutics could focus on key regulatory flexibilities identified in the November 2021 dialogue including but not limited to: 1 Multiple pathways in performing clinical trials, including decentralized and hybrid trials; 2 Removing local trial requirements and permitting operational flexibilities in the vaccine and therapeutics approval process by allowing waivers to trial location restrictions; 3 Enabling rolling submissions or other expedited regulatory actions in both the development and filing; 4 Permitting remote inspections; 5 Allowing multiple sites on a single license and using regulatory tools to manage post approval changes 6 Providing labelling flexibilities, including e-labelling and QR codes with no redressing and allowing for seamless language translation; and 7 Removing requirements for certificates of pharmaceutical product CPP The 2nd APEC Roundtable Dialogue on Post-Pandemic Regulatory Innovation & Convergence would focus on fostering a discussion of how certain regulatory flexibilities imposed during the COVID-19 pandemic by APEC regulatory authorities can be maintained and harmonized Janet Vessotskie 2021.11.25 Virtual
2 In partnership with AHC, AdvaMed as RHSC Medical Device Industry Coalition Co-Coordinator and the International Digital Health Coalition “IDHC” propose convening an “APEC LSIF RHSC Roundtable Dialogue on Accelerating Digital Health Regulatory Convergence in the Asia-Pacific” The IDHC is a global coalition of medical device and technology companies that share the common goal of increasing patient access to safe, effective, and high-quality digital health innovations IDHC’s mission is to collaborate with public and private sector stakeholders to advance digital health policy and regulatory solutions that benefit patients and healthcare professionals across the world The proposed roundtable dialogue would: 1 help implement new and reaffirmed commitments by APEC Ministers of Health in the 11th APEC High-Level Meeting on Health and Economy Joint Statement 24 August 2021 to “strengthen digital infrastructure” and continue advancing “regulatory convergence and reliance for medical product review and approval procedures in ensuring the safety and availability of medical products and other health technologies”; and, 2 help implement new and reaffirmed commitments by the APEC Ministers Responsible for Trade in its Joint Statement June 2021 to deliver “to deliver pragmatic and effective solutions on trade and health”, and “enhance the resilience of supply chains” The “APEC LSIF RHSC Roundtable Dialogue on Accelerating Digital Health Regulatory Convergence in the Asia-Pacific” could focus on practices including but not limited to: 1 Evaluating various policy and regulatory levers for developing risk-based, fit-for-purpose frameworks that support digital health technologies’ unique and iterative aspects, while also ensuring safety and effectiveness; 2 Developing a harmonized, risk-based, fit-for-purpose regulatory architecture for the qualification and classification of software as a medical device SaMD products and software in a medical device SiMD, including for artificial intelligence-based software and software with multiple functions; 3 Developing a harmonized, risk-based, fit-for-purpose regulatory architecture that incorporates innovative approaches to premarket review and change management for SaMD products; and 4 Maintaining a state-of-the-art cybersecurity regime that incorporates globally convergent best practices as risks in the cyber landscape evolve; Nicholas Diamond Secret 2021.11.23 Virtual
1 [Sample] Regulatory Convergence APEC Harmonization Center 2021.11.15 Virtual
No Title Name Secret Date State
2021 Application
7 AHC-SCH Medical Device Workshop APEC Harmonization Center Secret 2020.10.31 Virtual
6 AHC-NIDS Medical Device Vigilance Workshop APEC Harmonization Center Secret 2020.10.31 Virtual
5 AHC-KoNECT MRCT-GCP Workshop APEC Harmonization Center Secret 2020.10.31 Virtual
4 Reliance based Regulatory Decision APEC Harmonization Center Secret 2020.10.31 Virtual
3 RHSC Biopharm and Adv Thx Roundtable Dialogue on Post-Pandemic Regulatory Innovation & Convergence In partnership with AHC, PhRMA as RHSC Research-Based Industry Coalition Co-Coordinator proposes convening an “APEC LSIF RHSC Roundtable Dialogue on Post-Pandemic Regulatory Innovation & Convergence for Biopharmaceuticals and Advanced Therapies”, which: 1 builds on discussions from “Session 3: Accelerating Regulatory Convergence in the Asia Pacific in the Next Decade” of the “APEC LSIF Policy Dialogue on Developing a New Strategic Plan for Life Sciences Innovation in the Asia Pacific” 1617 September 2020 on examining whether permanent changes are necessary to regulatory systems informed by the COVID-19 pandemic; 2 helps implement new and reaffirmed commitments by the LSIF in its Statement on COVID-19 12 June 2020 to continue advancing regulatory convergence and building skilled human capacity needed to effectively and efficiently respond to future pandemics; and, 3 helps implement new and reaffirmed commitments by the APEC Ministers Responsible for Trade in its Statement on COVID-19 5 May 2020 to intensify efforts to make global supply chains more resilient and less vulnerable to shocks The APEC LSIF RHSC Roundtable Dialogue on Post-Pandemic Regulatory Innovation & Convergence could focus on practices including but not limited to: 1 Evaluating how clinical trials are designed and conducted, including use of decentralized clinical trials, use of remote monitoring of clinical trials, and collection of real-world evidence in trials; 2 Application of real-world evidence RWE in regulatory review and approval processes; 3 Modernizing inspections and audits, including through risk-based approaches for determining inspection frequency and through virtual inspections and audits; 4 Streamlining document submissions, including through electronic submissions; 5 Virtualhybrid meetings between regulators and sponsors, but not depending solely on written responses; 6 New regulations around telemedicine, virtual visits, and remote monitoring; 7 Availability of post-licensing patient materials online; 8 Remote access to electronic medical records; and, 9 Changes to regulatory authority structure to support pooling reserve resources for future crises Janet Vessotskie Secret 2020.10.31 In-person
2 2nd RHSC Workshop on Facilitated Regulatory Pathways In partnership with AHC, PhRMA as RHSC Research-Based Industry Coalition Co-Coordinator and the APEC Rare Disease Network jointly propose convening the “2nd APEC LSIF RHSC Workshop on Facilitated Regulatory Pathways” FRPs, which: 1 builds on the 1st APEC Virtual Workshop on FRPs in December 2020; 2 builds on the work completed in cooperation with the Centre for Innovation in Regulatory Science CIRS to provide an objective and observational “compendium”, or landscape, of the various FRPs currently in use by APEC regulatory authorities as of December 2020; 3 recognizes FRPs continue to be an important component to the efforts the LSIF is making to accelerate regulatory convergence through RHSCAHC and to address barriers to treatment for people living with a rare disease through RDN; 4 recognizes the recent attention on FRPs as a vehicle for accelerating the development, review, and authorization of COVID-19 vaccines and treatments; 5 responds to continued interest and activity by APEC regulatory authorities in the development and use of FRPs; 6 and implements relevant provisions in the RHSC Vision 2030 and Strategic Framework, expected to be endorsed in 2021 The 2nd APEC LSIF RHSC Workshop on Facilitated Regulatory Pathways would focus on the acceptance criteria, review criteria, decision criteria, and post-authorization activities for both primary facilitated pathways also known as expedited development pathways and secondary facilitated pathways also known as reliance mechanisms, with an emphasis on innovative medicines including advanced therapies eg, gene therapies Janet Vessotskie Secret 2020.10.31 In-person
1 RHSC Med Device Roundtable Dialogue on Post-Pandemic Regulatory Innovation & Convergence In partnership with AHC, AdvaMed as RHSC Medical Device Industry Coalition Co-Coordinator proposes convening an “APEC LSIF RHSC Roundtable Dialogue on Post-Pandemic Regulatory Innovation & Convergence for Medical Devices”, which: 1 builds on discussions from “Session 3: Accelerating Regulatory Convergence in the Asia Pacific in the Next Decade” of the “APEC LSIF Policy Dialogue on Developing a New Strategic Plan for Life Sciences Innovation in the Asia Pacific” 1617 September 2020 on examining whether permanent changes are necessary to regulatory systems informed by the COVID-19 pandemic; 2 helps implement new and reaffirmed commitments by the LSIF in its Statement on COVID-19 12 June 2020 to continue advancing regulatory convergence and building skilled human capacity needed to effectively and efficiently respond to future pandemics; and, 3 helps implement new and reaffirmed commitments by the APEC Ministers Responsible for Trade in its Statement on COVID-19 5 May 2020 to intensify efforts to make global supply chains more resilient and less vulnerable to shocks The “APEC LSIF RHSC Roundtable Dialogue on Post-Pandemic Regulatory Innovation & Convergence for Medical Devices” could focus on practices including but not limited to: 1 Evaluating how medical device clinical trials are designed and conducted, including use of decentralized clinical trials, use of remote monitoring of clinical trials, and collection of real-world evidence in trials; 2 Application of real-world evidence RWE in medical device regulatory review and approval; 3 Modernizing inspections and audits, including through a risk-based approaches for determining inspection frequency, b virtual inspections and audits, and c participation in the Medical Device Single Audit Program MDSAP; 4 Streamlining document submissions, including through electronic submissions; 5 Virtual or hybrid meetings between regulators and sponsors; 6 New regulations around telemedicine, virtual visits, and remote monitoring; 7 Remote access to electronic medical records; and, 8 Changes to medical device regulatory authority structure to support the pooling of resources reserved for future crises Janet Trunzo Secret 2020.10.31 In-person
No Title Name Secret Date
2020 Application
8 Workshop on Harmonizing Regulatory Pathways for Orphan Products Prof Matthew Bellgard Secret 2019.10.31
7 RHSC-AHC Workshop on Regulatory Reliance Camille Jackson Secret 2019.10.31
6 RHSC-AHC Workshop on Expedited Pathways Camille Jackson Secret 2019.10.31
5 Pilot CoE Workshop on Total Product Life Cycle of Medical Device You Kyoung Lee Secret 2019.10.31
4 Pilot CoE Workshop on Ensuring the Quality of Raw Materials in Advanced Therapies in APEC Economies Dr Phillip Nguyen 2019.10.30
3 CoE Pilot - Medical Device Post Market Vigilance Ananda Padmanabhan Muthalagu Secret 2019.10.29
2 Public-Private Dialogue PPD on experiences and good practices in quality control tests for Biotechnological products in APEC economies Mr Luis Enrique MORENO EXEBIO 2019.10.28
1 [Sample] Regulatory Harmonization APEC Harmonization Center 2019.09.26
No Title Name Secret Date
2019 Application
8 PILOT COE WORKSHOP ON SUPPLY CHAIN SECURITY FOR MEDICAL PRODUCTS Professor PTThomas Secret 2018.10.12
7 Biopharmaceuticals Workshop Lee, Yoo-kyoung Secret 2018.10.12
6 Introduction of Medical Device PWA roadmap Hyeonho Kim Secret 2018.10.12
5 APEC - Regulatory Convergence Awareness Workshop APEC Harmonization Center AHC Secret 2018.10.12
4 CoE Pilot training : Supply Chain Intergrity Hyeyoung Choi 2018.10.12
3 CoE Pilot Workshop: Good Registration Management GRM Dr Suchart Chongprasert 2018.10.12
2 APEC Training course on Good Registration Management GRM Lahouari Belgharbi 2018.10.10
1 [Sample] Regulatory Harmonization AHC Secretariat 2018.09.10
No Title Name Secret Date
2018 Application
8 CoE Pilot - Biotherapeutics Workshop James Leong Secret 2017.09.30
7 Medical Device Workshop on Roadmap Overview and Strategic Planning Kim, Hyeonho Secret 2017.09.29
6 APEC LSIF Global Supply Chain Integrity and Security Roadmap Pre-CoE Workshop Eun Hee Kim Secret 2017.09.27
5 [CoE Pilot]Medical Device Vigilance Tai-gwon, Kim Secret 2017.09.26
4 AHC-ICH Workshop in Biopharmaceuticals to Promote Regulatory Harmonization Lee, Yoo-Kyoung Secret 2017.09.21
3 Medical Device Workshop 2018 Jared Auclair Secret 2017.09.16
2 Multi-Regional Clinical Trials MRCTs and Good Clinical Practice GCP Barbara Bierer Secret 2017.08.19
1 [Sample] Regulatory Harmonization AHC Secretariat 2017.05.25
No Title Name Secret Date
2017 Application
9 To Promote Regulatory Convergence for Medical Device Vigilance - Establishing international cooperation for management of adverse events on medical device. Chunil Lim_ncis Secret 2016.10.11
8 Bioparmaceuticals(Biosimilar) Regulatory Harmonization Yoo-Kyoung Lee Secret 2016.09.30
7 Pharmacovigilance (PV) Regulatory Harmonization Kim, Sang Hyun Secret 2016.09.30
6 APEC RHSC CoE Pilot Workshop “Introduction to the Supply Chain Roadmap” Katherine Bond, ScD Secret 2016.09.30
5 Good Registration management regulatory science center of excellence pilot workshop Yu-Hua Huang Secret 2016.09.29
4 Pharmaceutical Supply Chain Security Kennard Brown, J.D., Ph.D. Secret 2016.09.27
3 Pharmaceutical Supply Chain Security Kennard Brown Secret 2016.09.27
2 Advanced Therapeutics Jennifer Harmon Secret 2016.09.23
1 Advanced Therapeutics Jennifer Harmon 2016.09.15