Jeewon Joung

Ministry of Food and Drug Safety Republic of Korea

APEC RHSC Biotherapeutic Roadmap Activity

- How to Work Together with Global Initiatives -

I. APEC Biotherapeutic Products

Roadmap

II. APEC Biotherapeutics Workshop

III. How to work together

IV. Conclusion

Outline

2

• Created in 1989, currently with 21 member economies • Goals

– Promote trade, sustainable economic growth and prosperity of member economies through policy alignment and economic and technical cooperation

Activities - to enhance and sustain regulatory convergence and capacity building efforts • Conduct surveys and research • Provide education • Establish strong networks • Support international cooperation

9 Roadmaps (Champion Economies)

1) MRCTs (Japan) 2) Good Supply Chain Practice (US) 3) GRP, 4) Combination products & 5) Good Submission Practice (Chinese Taipei)

6) Biotherapeutics & 7) PV (S.Korea) 8) GCP inspection (Thailand)

9) Cellular Therapies (Singapore)

Role of APEC RHSC Roadmaps

RHSC Roadmaps

Regulatory Convergence

International Standards

Initiated to create the roadmap in line with LSIF strategic plans for the convergence of approaches to the regulation of biological products in APEC economies (Sep 2011, APEC SOM Meeting)

- Korea was designated “champion nation” to establish the roadmap The Roadmap for Biotherapeutic Products was officially endorsed at RHSC meeting (Feb. 2013)

Scope

Among biological products, this roadmap will only cover the area of recombinant DNA products, monoclonal antibody, and therapeutic vaccines. Vaccines, blood products and cell/gene therapy products are NOT within the scope of this roadmap.

Specific Action Plans and Time Frames

8

2019 ~2020

2015~2016

Step 2

Assessment of

regulatory

environment and

gaps between APEC

members through gap

analysis and

workshop

Step1

2017~2018

Step 3

2013 ~2014

Step 4

Training/workshop

Recommendations for

regulatory

convergence

•Establish concrete

training system

•Build up collaborative

system and information

sharing network

•High regulatory

convergence

Assessment &

training/workshop

•Analyze steps 1, 2

•Review post-

implementation of

international

guidelines

•Revise training plans

and continue trainings

to foster experts

Training &

Workshop

•Develop training

curriculum and

conduct training and

workshop

APEC Biotherapeutics Workshop

– A tool for performance ‘APEC Biotherapeutic Products Roadmap’

– Performance

When Where Participants Main topic

1st Sep 2013

Seoul, Korea 368 participants from 15 countries + WHO (Regulators from 10countries)

• ICH/WHO role in standard setting • Clinical, nonclinical and quality of biotherapeutics

2nd May 2014

Seoul, Korea 279 participants from 22 countries + WHO (Regulators from 14 countries)

• Life cycle management • Immunogenicity • Acceptance of foreign clinical data

Analysis of regulatory status in APEC

• Survey conducted to understand the areas of gaps and opportunities for regulatory convergence; 10 out of 21 economies responded (2014.2~5)

• Most responded countries have already either partially or fully implemented the ICH guidelines (9 out of 10)

Eg. Thai FDA has recently implemented Q5E

• Regulatory gap between harmonized and non-harmonized countries may be wide

Prioritization of what is needed for non-harmonized countries should be discussed

Opportunities for Convergence

• Convergence between guidelines – Convergence with guidelines can lead to convergence of

regulation in APEC economies

– Much overlap between WHO and ICH Guidelines WHO guidelines for biotherapeutics and biosimilars were recognized as core guidelines for convergence

• Identified opportunities for convergence in 2014; – Post-approval changes

– Immunogenicity assessment for biotherapeutics and biosimilars

– Acceptance of foreign clinical data (Applicability of ICH E5 to biotherapeutics and MRCT)

Training may be required in these topics for non-harmonized countries

Recommendations to RHSC • Create a mechanism for high level engagement with

policymakers

• Next AHC workshop should delve into the issues around

– immunogenicity of biotherapeutics and biosimilars

– Applicability of ICH E5 to biotherapeutics

– Post approval changes (2015)

• Work to incorporate modules in the ‘Center of Excellence (CoE)’ pertaining to CMC questions in life cycle management and post approval changes

• Excellent initiatives in ICH, APEC RHSC, WHO, ICDRA; Each has its own strength and should be leveraged

2015 Plan: Step 2, Training/Workshop

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Working Group • Assessment of step 1 and drawing of future strategies •Design of training program - analyzing other training programs such as case studies from WHO as teaching tools - pilot training programs with written, audio, video and presentation formats Training • Small-topic-based training sessions/workshops • Experts from NRAs, industries, academia will be the faculty

2015~2016

Step 2

Training &

Workshop

•Develop training

curriculum and

conduct training and

workshop

14

How to work together

for Regulatory Convergence

• Different starting point and legislation

• Different needs and expertise for authorization in developing countries vs. developed countries

• Interpretation without common language and principles

• Differences in the decision making for marketing authorization on the same clinical data presented to each regulatory authority

Regulatory challenges for biotherapeutics

Challenges for regulatory authorities

• Growing complexity in medicinal products (new chemical entities and innovative products)

• Gaps/vulnerabilities in global regulatory oversight providing opportunities for the tampering and counterfeiting

• Pressures to control and reduce regulatory public expenditures

• Pressure to harmonize and align regulatory practices and activities

• Growing number of international regulatory initiatives, lacking integration and strategic oversight

– Overlapping tasks and exhaustion of resources

MFDS Participation in global initiatives for biological products

International Coalition of Medical Regulatory Authorities (ICMRA)

International Pharmaceutical

Regulators Forum (IPRF)

International Conference on Harmonization

(ICH)

APEC Life Science

Innovative Forum

ICH expert committee

IPRF Working Group

APEC RHSC

Q3C, Q3D, Q7 q&a

S1, S10

E2C, E6, E17, E18

M1, M4E(R2), M7

Biosimilar (Chair)

GCP inspection

Cell therapy

Gene Therapy

GMP Inspection

Safety information

APEC AHC

WHO Collaboration

Mapping existing international initiatives ECBS

ICDRA

Collaborating Center

WPRO Regional alliance steering committee

DCVRN

GMP – coordination of international inspections

International Generic Drug Regulation Pilot

• Development of distinctive roles for each international bodies (or stakeholders) to avoid duplication of work and make best efficient way of collaboration

‒ Identification of possible linkage with existing international bodies is needed

E.g. APEC-WHO back-to back meeting (2014.5)

• Purpose of international collaboration should aim for efficient and timely global development and access to biotherapeutics including biosimilars

• A strong initiative is needed for strategic direction and productive collaboration

Direction for collaboration

WHO ICMRA ICH IPRF APEC

Purpose Standardization of biological products

Global strategic direction from regulatory heads

Harmonization by common regulatory standards

Cooperation and convergence at technical/operational level

Promote convergence and best practices

Roles Development of international guidelines Implementation workshop

Identification of strategic areas of shared need or opportunity

Development of regional guidelines

Regulatory information sharing, Support implementation of global guidelines

Training, Capacity building

Level of task

Strategic Operational

Strategic Operational Operational Operational

No of members

194 20 (incl. WHO)

10 (SC incl. WHO) 14 (GCG)

18 (incl. WHO)

21

Major global initiatives in biotherapeutics

• Objectives: To provide strategic advocacy for a range of areas and actions common to medicinal products regulators and to identify areas for potential synergy

• Background: Established interim in 2013 with 20 member countries including WHO (Chair: Health Canada,

Vice chair: PMDA, HRPA)

• Projects Underway

ICMRA

Projects

Developing Governance and Terms of Reference

Mapping existing initiatives/enablers

Communication strategy concerning the ICMRA

GMP – coordination of international inspections

Generic drug initiative – building on current international pilot

Rapid sharing of information and confidentiality commitment within the ICMRA

Capacity building initiative

Cooperation among global initiatives

ICMRA

ICH

APEC

IPRF

Strategic direction

WHO

Technical Operation

ICMRA -Global strategic direction

Proposed scheme for collaboration in the area of biosimilars

IPRF Biosimilar Working Group - Development of scientific reflection paper and common product assessment

information -

APEC Harmonization

Center - Implementation and training of guidelines -

WHO - Establishment of

international

standards -

MFDS - Interaction

Core -

• Regulatory convergence should be used as a tool to increase global access to biotherapeutics of high quality, safety, and efficacy and to foster global development of innovative product

• Priority should focus on

‒ Need for better understanding of ‘convergence’

‒ Understanding gaps and different environment

‒ Linkages for efficient communication

‒ Collective use of resources

‒ Sharing of information and knowledge

• APEC Biotherapeutic Products Roadmap will play a key role in

‒ Strengthening mutual reliance and synergies

‒ Achieving better use of work products

‒ Sharing of best practices

Conclusions

Thank you

Jeewon Joung Tel +82 43 719 3504 E-mail jeewon@korea.kr