This document discusses Asia-Pacific Economic Cooperation (APEC) and its role in regulatory harmonization for pharmaceuticals. It contains the following key points: 1. APEC aims to facilitate economic growth, cooperation, trade and investment in the Asia-Pacific region, with 21 member economies. It established goals in 1994 to achieve free trade by 2010/2020. 2. APEC addresses regulatory harmonization through the Life Sciences Innovation Forum and Regulatory Harmonization Steering Committee, with a vision for maximum convergence by 2020. 3. Areas of focus include appropriate use of the Certificate of Pharmaceutical Product, PIC/S membership, management of multiple sites, and risk-based evaluation. The

1. Presented By…..
Mr. Tarif Hussian
M.Pharm. (DRA)
Guided By…..
DR. Arun Nanda
Professor of Pharmaceutics
DEPARTMENT OF PHARMACEUTICAL SCIENCES
Maharshi Dayanand University, Rohtak

2. CONTENTS
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 Introduction
 Bogor Goals
 APEC's Pillar
 India And APEC
 APEC & Pharma
 Life Sciences Innovation Forum
(LSIF)
Regulatory Harmonization
Steering Committee (RHSC)
Areas Of Appropriate Regulatory
Practice
 ASIA PACIFIC 2020 ROADMAP

3. INTRODUCTION
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 Asia-Pacific Economic Cooperation, or APEC, is the
premier forum for facilitating economic growth,
cooperation, trade and investment in the Asia-Pacific
region.
 APEC was established in 1989 in Canberra, Australia
 Headquarters: Singapore
 Executive Director : Dr Rebecca Fatima Sta Maria
 APEC Summit 2018 : Papua New Guinea

4. MEMBER ECONOMIES
 Australia
 Brunei
 Canada
 Indonesia
 Japan
 South Korea
 Malaysia
 New Zealand
 Philippines
 Singapore
 Thailand
 United states
 Taiwan
 Hong Kong
 China
 Mexico
 Papua New Guinea
 Chile
 Peru
 Russian
 Vietnam
NOTE - India is observer of APEC
since 2011 and has applied for
membership.
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6. BOGOR GOALS
 The Bogor Goals are a set of targeted goals for
realizing free and open trade in the Asia-Pacific
region agreed by member economies of APEC in
1994 in Bogor, Indonesia.
 The Bogor Goals set 2010 for developed members
and 2020 for developing members to achieve Free
Trade and investment.
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7. APEC's Pillar
APEC's First Pillar: Trade and
Investment Liberalization
APEC's Second Pillar: Trade
Facilitation
APEC's Third Pillar: Economic and
Technical Cooperation
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8. INDIA and APEC
 APEC’s activities cover a wide variety of disciplines.
 It would provide India with an opportunity to socialize with the
developed economies of the Asia-Pacific region.
 It is one of the missing link in ‘India’s Act East Policy’.
 APEC will provide India a perfect platform to integrate in global
economies.
 With APEC membership, India’s chance to get into FTAAP and TPP
brightens.
FTAAP: FREE TRADE AREA OF THE ASIA-PACIFIC OR TPP : Trans-Pacific Partnership
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9. APEC & PHARMA
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 Harmonizing Regulatory Practices Across APEC: Good Clinical
Research Inspection Global pharma necessitates harmonized
regulation.
 Multinational drug companies conduct clinical research and
trials in many countries and market the resulting products
around the world. And in each country the companies face a
different regulatory environment.

10. Life Sciences Innovation Forum (LSIF)
(2002)
 To address the challenges such as infectious and
chronic disease and ageing populations.
 The LSIF brings together scientific, health, trade,
economic and financial considerations.
 Promote innovation in the life-sciences sector.
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11. Regulatory Harmonization Steering Committee (RHSC)
2008
 Created under the authority of the LSIF
 Promote a strategic and coordinated approach to
medical product regulatory harmonization/convergence
and capacity building efforts within the APEC region.
 Promote Multi-Regional Clinical Trials (MRCT).
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12. (APEC RHSC Vision 2020)
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➢ In 2010, the RHSC established under APEC’s Life Sciences
Innovation Forum (LSIF) advocated for regulatory
convergence in pharmaceuticals for improved public health
and economic development.
➢ Regulatory Convergence : Regulations for greater regulatory
cooperation and does not necessarily require the regulations
to be “harmonized’’.
➢ Ultimate AIM for APEC economies to achieve the maximum
level of regulatory convergence feasible by 2020.

13. BUILDING A BETTER HARMONIZATION MODEL
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Development Organizations
(Standards, Guidance, Tools)
Key Enabler:
LSIF + RHSC + APEC Harmonization Center
* Life Sciences Innovation Forum
ICH, IMDRF/
GHTF,ISO etc
* Regulatory Harmonization Steering Committee
Key role played by WHO

14. AREAS OF APPROPRIATE REGULATORY
PRACTICE
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 CPP (Certificate of Pharmaceutical product)
 PIC/S(The Pharmaceutical Inspection Co-operation
Scheme) membership
 Management of Multiple Sites.
 Risk-based evaluation based on information.

15. APPROPRIATE USE OF THE CPP
(CERTIFICATE OF PHARMACEUTICAL PRODUCT)
➢ CPP was developed by the WHO as a tool to
support product registration among national
regulatory authorities.
➢ Requirement for the CPP has been removed
from both its pre- and post-marketing control
requirements.
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16. Appropriate use of PIC/S membership
 APEC economies that are PIC/S members could
utilize the PIC/S network and common high
standards to make significant positive moves
towards greater convergence in GMP compliance
assessment and conduct of inspections.
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17. Healthy Asia Pacific 2020 Roadmap
FOCUSES ON KEY AREAS
 Prevention and control of non-communicable diseases, including mental illnesses,
disabilities, violence and injuries.
 Strengthening health systems to support universal health coverage.
 Improving health emergency.
 Global Medical Product Quality and Supply Chain Integrity.
ADDITIONAL ACTIONS
 Invest in the health of our population at all stages of life
 Promote the global health value chain using a health systems approach.
 Enhance regional cooperation on human security
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18.  One-site-one-license process is commonly
deployed among the APEC economies which are
CPP- Dependent.
Note - This approach is quite the opposite of that
practiced by ICH members.
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19. ENHANCING SME (SMALL AND MEDIUM ENTERPRISES) BUSINESS
ETHICS IN THE HEALTHCARE INDUSTRY
 SMEs most impacted by corruption
 APEC project on SME business ethics
 Beginning in 2011, the Asia Pacific Economic Cooperation (APEC) multi-year
initiative on Business Ethics for SMEs has helped small and medium
enterprises in the biopharmaceutical and medical device industries develop
codes of ethics to self-regulate their business practices.
 Today, as a result of the APEC initiative, codes of ethics have been adopted
and are undergoing implementation by around 60 biopharmaceutical and
medical device industry associations and their member companies from 19
economies across the Asia-Pacific, representing more than 14,000 firms.
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