regulatory paradigms for change: a singapore …9emergence of new products development &...

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Regulatory Paradigms for Change: A Singapore Perspective

Dr John LimDr John LimChief Executive OfficerChief Executive Officer

HEALTH SCIENCES AUTHORITYHEALTH SCIENCES AUTHORITY

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ScopeIntroduction To Singapore

Overview Of HSA

Regulators’ Challenges

Regulatory Paradigms For Change

Conclusion

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Singapore- An Introduction

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SINGAPORE

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Singapore

Ethnic Groups

8.3%1.7%

76.2%13.8%

Total land area: 697.1 sq kmPopulation– 4.5 million– ethnic groups

OTHERS

MALAYS

INDIANS

CHINESE

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Overview of HSA

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HSA Functions & Roles

Drugs & Devices• Product Risk Assessment• Quality Systems Audit• Clinical Trials Regulation• Licensing• Vigilance & Surveillance• Enforcement

• Bloodbanking &Transfusion Services

• Haemovigilance

• Health Products • Quality Analysis• Chemical Metrology

Options for new & greater synergies across Groups

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Health Products ControlMedicinal products Chinese Proprietary MedicinesMedical DevicesCosmetic Products

OthersSmoking and Tobacco Products

Health Products Regulation Group

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Key Functional Areas of Health Products Regulation

Health Products Regulation Group

Product Evaluation & Registration

Manufacturing & Quality Audit

Clinical Trials

Pharmacovigilance

Enforcement & Prosecution

Strategy & Policy Devt

Innovative TherapeuticsPharmaceuticals

Medical DevicesChinese Proprietary Medicines

Pre-market Post-market

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Regulators’Challenges

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Key Challenges (1)Globally…

Increasing pressure on regulators & industry Public & political expectationsShifting of risk appetite

Resource constraints

Scope of issues extending beyond routine drug approval paradigm

Counterfeits and illegal drugs

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Key Challenges (2)Globally…

Emerging diseasesAvian flu

New types of health productsGene therapy, nanotechnology

World is now a smaller placeAdvance in transportation & communications

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Key Challenges (3)In Singapore…

Relative smallness of agencyNeed to apply innovative approaches

Biomedical Sciences Initiative in SingaporeBeing an enabling regulator

Talent attraction and retentionOpportunities from HSA’s unique structure and for research and collaborative development

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Evolving Role of the RegulatorRapid development in translational research

Need to enhance research & clinical trials infrastructureEmergence of new products

Development & enhancement of regulatory frameworks forMedical devicesBiologics & Biotech productsHuman Cell & Tissue TherapyComplementary medicines

Implementation of Health Products ActStrengthen Post-marketing Compliance Surveillance & Safety Monitoring

Towards a networked Regulator to enhance public health & safety

Basic Translational Clinical Service Delivery

Biomedical ResearchBench Bed

A*STAR MOH & HSAGAP

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HSARegulatory Paradigms For Change

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Determining Regulatory Balance

Regulator

ProtectPublic

Enable &Facilitate

Relevant, Responsive & Ready

Regulatory Paradigm (1)

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Communicating Regulatory Balance

No health product is 100% safe“Registered” does not = risk-free product

Constant balance needed: Role, Policy & Resources

Product People

Practice

Safety Need for Effective Communication & Trusted Spokespersons

Regulatory Paradigm (2)

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Regulatory Philosophy (1)Judicious adapting of good international regulatory principles & practices to meet Singapore’s unique situation, without:

Over-regulatingSimplistically adopting systems of reference agencies Blindly approving products already approved elsewhere

Wise use of regulatory tools & risk-based regulation

Tap on expertise of external experts and researchers

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Regulatory Philosophy (2)Engage in research to advance regulatory knowledge

Rationalise risk management framework with clarifications of roles of risk managers at various levels

Life-cycle approach to health products regulation (concept under development)

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Regulatory Philosophy (3)Foster strategic partnerships internationally and regionally

Information sharing and collaborations through MOUs &MRAsLeverage on expertise and work of more advanced agenciesWork-sharing with like-minded agencies

Proactive communications strategy – Inspiring trust

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Legislative RestructuringHealth Products Act

To consolidate medicines control laws

Modular approach – more responsive & flexible to deal with different degrees of risk

Tighter control for higher-risk productsLighter control for lower-risk products

More efficient process to adjust legislation

Covers regulation of health products, dealers’obligations and more appropriate penalties

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Non-Clinical Clinical Manufacturing MarketingApplication Marketing

Phases ofProduct

Development

PrescriptionDrugs &Devices

OTC Drugs& Devices

Complemen-tary

HealthProducts

CosmeticProducts

Pre-Marketing Post-Marketing

RelativeRisk

Higher

Lower

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New Drug Evaluation – Risk-based Approach

Product approved by one drug regulatory agency

Verification based on fullassessment report by reference regulatory agency.Internal evaluation only.

Full

Abridged

Verification Product approved by two reference agencies

No prior approval by any country

Pre-submissionconsultation

Full quality, non-clinical, & clinical data.Requires internal & external evaluation.

Full quality data and Phase II & III clinical data.Requires internal & external evaluation.

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Inspiring Trust

Trust needs time to build upLong-term communication strategy neededProactively engage stakeholders

Ongoing education and information sharing

Effective spokespersonThis Trust will serve the Regulator well in times of crisis

Proactive Communications Strategy

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Conclusion

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ConclusionChallenges and role of Regulators evolving

Regulatory paradigms must stay relevant

Legislative Restructuring when needed

Risk-based approach to regulation

Need to enhance communication strategies and skills

Global partnership is a key success factor

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Thank You!visit us again: www.hsa.gov.sg