Recent APEC Developments in Promoting Regulatory

Harmonization and Capacity Building

Pre-ICDRA Conference28-29 November, 2010

Singapore

Context• Much effort underway at international, regional

and economy level to strengthen capacity and efficiency of NRAs in carrying out ability to protect and promote public health

• Goal: most effective use of limited resources

• Question: are such efforts effective as they could be?

• Question: what role is APEC playing in trying to advance such efforts ?

Cooperative Efforts:Some Considerations

• Must be clear on what one trying to achieve and how best to achieve

• Should be reflected in goals and strategies

• Coordination of effort increasingly important in achieving desired outcomes

A More Effective Approach

• Cooperative regulatory efforts should, whenever possible, be directed towards multilateral networks and fora as a means of maximizing investment and impact: “doing things once –collectively”

• Where this is not possible or appropriate, the efforts of regulatory bodies and international organizations should nonetheless be complementary to extent possible with goal of promoting synergies and avoiding duplication of effort

Prerequisites

• Strategic discussions among interested parties (including WHO)

• Taking stock of what’s going on or planned: “connecting all the dots”

Overview of APEC • Asia-Pacific Economic Cooperation (APEC) created

in 1989• Currently comprised of 21 member economies• Goals: Promote trade, sustainable economic growth

and prosperity of member economies through policy alignment and economic and technical cooperation

• Unique forum , operating on basis of– Non-binding commitments, open dialogue and equal respect

for views of all participants– Decisions by consensus; commitments undertaken on

voluntary basis– Individual and collective action

Source: APEC

Life Sciences Innovation Forum• APEC Leaders endorsed establishing LSIF,

October 2002, Los Cabos, Mexico• Recognized interest in promoting public and

economic health improvement through life sciences innovation

• Annual forum to serve to promote policy environment to foster growth of life sciences innovation

• Tripartite: government, industry and academia

LSIF an enabler of harmonization• Unique in that LSIF doesn’t produce harmonized

guidances; rather, promotes use of existing international guidelines

• Ability to access APEC funds to advance projects

• Voluntary basis for engagement: ensures participation of those economies interested and committed to cooperation

• Linkages to international harmonization initiatives

• Tripartite structure / complementary roles: government, industry, academia

Training: a Key Focus

APEC LSIF has to date sponsored a successful series of workshops on anti-counterfeiting, clinical trial evaluation and inspection and on promoting a better understanding of international guidances related to the development, registration and surveillance of pharmaceuticals and medical devices

However…Despite progress made, recognition that

LSIF had not been used to its full potential in promoting a more strategic and effective

approach within the APEC region as a driver of regulatory harmonization and

cooperation

Outcomes of Strategic DiscussionsLima, Peru 2008

Series of recommendations, including two of strategic importance:

– Support for the establishment of the APEC Harmonization Center (AHC)

– Creation of a Regulatory Harmonization Steering Committee (RHSC)

Seoul, June 15-18, 2009: laying the foundation

• Inauguration of the AHC• Formation and first meeting of RHSC• Workshop on MRCTs which attracted

over 600 participants, including officials, experts and interested parties from 15 economies

APEC Harmonization Center (AHC)

• APEC-wide resource to enhance and sustain harmonized and capacity building efforts by:– conducting research and surveys– providing educational programs– publishing and web posting– establishing networks and exchanges among

participants and other international institutions

• Operate under the authority of LSIF, with direction from RHSC and an international advisory board

RHSC Mandate and GoalsTo promote a more strategic, effective and

sustainable approach to harmonization by:– Proactively identifying and prioritizing projects

seen to be of greatest value– In partnership with AHC, establish or

strengthen linkages with harmonization initiatives, training organizations and other key players in efforts to promote complementaryactions and most effective use of resources

– Products within remit of SC: medical products, notably drugs and devices

RHSC Members

• Regulators from Canada, China, Chinese Taipei, Japan, Republic of Korea, Peru, Thailand and USA with official observers from Mexico and Singapore

• Industry representatives from drug and medical device sectors

• Director of APEC Harmonization Center

Progress to Date

• Overall Strategic Action Plan developed• Operating procedures and multi-year

planning cycle adopted• Permanent secretariat established• Harmonization targets and roadmaps to

achieve goals for drugs and devices under development

Progress to Date

• Series of successful workshops and projects which generated recommendations for further action by RHSC in advancing harmonization efforts in relation to good review practices, supply chain and multi-regional clinical trials

• Training strategy and website under development• Logo selected to promote branding and awareness

Training• Develop training strategy and overall plan• Approach

– Workshop as diagnostics– Act upon recommendations from workshop– Use regional approach vs. individual country– Capture information for future use and by those

unable to attend in person

RHSC Workplan for 2010-2011• MRCT

– MRCT/Tripartite Symposium (Drugs): Sept. 13-15, 2010– Device clinical trials: November 13-15, 2010

• Good Review Practices and the exchange and use of regulatory information– Drugs: November 3-6, 2010– Devices: 2011

• GHTF Implementation: 2011• Pharmaceutical quality:

– supply chain May 12-13, 2010; 2nd planned 2011– ICH QbD workshop

• Pharmacovigilance• Stem cells (prospective harmonization): Spring 2011• 6th Pan-Asian Regulatory Conference (IFPMA/DIA/AHC),

April 2011

Elements of a strategic approach to harmonization efforts

• Steering committee composed of committed individuals from regulatory authorities, industry and academia with common vision and ability to execute

• Establish harmonization goals and a plan or “roadmap” to achieve these goals

• All activities should support goals and form part of the roadmap

• Approach takes advantage of existing international guidelines and best practices, the AHC and other key players to promote complementary, coordinated actions and most effective use of overall resources

Long term goals

Strategies / “roadmaps”

Individual projects form part of roadmap and contribute to goalsMove away from Ad Hoc/Individual Proposals 

An Example: Multi-regional Clinical Trials

• June 09 and Sept. 10 workshops in Seoul served as a “diagnostic” of challenges, issues, opportunities

• Led to a series of recommendations on addressing challenges to MRCT

• Recommendations to be considered by RHSC in developing project proposals leading to concrete, directed actions as part of proposed MRCT roadmap

Recommendations• Research on ethnic factors through China– Japan –

Korea Tripartite Initiative• Targeted training• Points to consider document or possibly expanded

ICH guidance?• Standardized reporting templates• Repository of regulatory requirements• Policy discussions• Etc.

…all to be prioritized and acted upon through RHSC as new follow on projects as part of a roadmap on promoting MRCTs

2010 MRCT Seoul Workshop

2010 Multi-Regional Clinical Trials Seoul Workshop-Highlighting Korea, China and Japan Tripartite Symposium

SEPTEMBER 13‐15, 2010

• SEP 13-15, 2010 (3 Full-day)

• 2010 Multi-Regional Clinical Trials Seoul Workshop

- highlighting Korea-China-Japan Tripartite Symposium

• 410 participants from 14 economies

- More than 30 experts invited as Chairs, Speakers & Panelists

• Program

: Day 1: Study Design & Operational Aspects

Day 2: Korea-China-Japan Tripartite Symposium

Day 3: Case Study on Oncology & Panel Discussion

Second Example: Good Review Practices

• Two workshops hosted by Chinese Taipei (June (devices), November (drugs) 2010

• Recommendations from workshops will help with design of two year project on good regulatory practices

GRP: a definitionGood Review Practices are review standards (such as standard operating procedures and templates) and related initiatives (such as reviewer manuals and training programs) designed to ensure the timeliness, predictability, consistency and high quality of reviews and review reports

GxP and QMS

GAPGMPGDPGCPGPhVP..etc

Industry Regulators

Good Regulatory Practices

• Good Review Practices

Common Objectives: Consistent, high quality product

QMS

QMS

Role of GRP in promoting regulatory cooperation

• Implementation of good review practices, combined with adoption of common, science based standards and guidelines that define regulatory expectations for establishing the safety, efficacy and quality of medicinal products, are essential in building trust and confidence in regulatory systems

• Provides solid basis for exchange and optimal use of regulatory information which in turn promotes regulatory efficiencies and best practices

Considerations

• Implementation of Good Review Practices doesn’t mean decisions of different regulatory authorities will be the same…but can facilitate reaching decisions in a timely, predictable and consistent manner

• Question: is it meaningful to talk about ‘harmonization’?

Recommendations• Develop common framework and plan for

promoting GRP and science-based review/decision-making:– Working definitions/concepts– Regulatory “toolbox” – Scorecards, performance indicators

• Training: – Competency-based professional

development/certification – To include training of regulatory authorities and

industry on product development, GRP and science-based review

– Annual curriculum: sustaining role for AHC

Next Steps• Finalize and submit 2 year APEC GRP project

proposal from Chinese Taipei • Several complementary components:

– Training program: foundational and advanced courses for drugs and devices (subsequently migrate to AHC?)

– GRP framework/toolkit– Framework/approaches for the use and exchange of

regulatory information

• Target audience to include individuals responsible for GRP and in position to affect change

• Time frame for activities: 2011 -12

Building a Better Harmonization Model

ICH WGsGCG

Development(Stds, Guidances)

Reg Forum

+ NRAs: Australia, Brazil, China, Chinese Taipei, India, Korea, Russia, Singapore

Key Enabler:Interface

APEC Economiesand beyond

APEC Harmonization Center + RHSC

Summary• Exciting new developments within APEC that

have implications beyond the region in advancing regulatory harmonization in a more strategic, sustainable and effective manner

• Directed towards concrete, complementary actions• Key role as an enabler: building a better global

harmonization model• Developments to be posted on AHC website in

near future (www.apec-ahc.org)