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