Managing Changing Regulatory Paradigms

Transcription

1 Managing Changing Regulatory Paradigms Assoc Prof John Lim Chief Executive Officer Health Sciences Authority, Singapore 8 Feb 2014 Copyright of the Health Sciences Authority 1

2 Congratulations to PMDA! Copyright of the Health Sciences Authority 2

3 Scope Overview of HSA Responses to Changing Regulatory Trends Copyright of the Health Sciences Authority 3

4 HSA Organisational Chart Professional Board HSA Academy HSA Board Chief Executive Officer Staff Strength 974 Professional Quality & WSH Risk Management & Internal Audit Corporate Services Blood Services Group Health Products Regulation Group Applied Sciences Group Corporate Communications Emergency Planning Facilities Management Finance Human Capital Mgmt Information Management Legal & Prosecution Organisation Development & Excellence Quality Management Strategy & Business Transformation Blood Supply Management Blood Resources Patient Services Clinical Services Pre-market Vigilance, Compliance & Enforcement Audit & Licensing Staff strength 293 (as of 31 Dec 2013), Forensic Medicine Forensic Science Analytical Science Copyright of the Health Sciences Authority 4

5 5 Copyright of the Health Sciences Authority 5

6 Health Products Regulation Group Pre-marketing Div : Vigilance, Compliance & Enforcement Div : Audit & Licensing Div Ensures that drugs, innovative therapeutics, medical devices and health-related products in Singapore are wisely regulated to meet appropriate standards of safety, quality and efficacy Copyright of the Health Sciences Authority 6

7 HPRG s Key Functional Areas HPRG Group Director s Office Pre-Marketing Vigilance, Compliance & Enforcement Audit & Licensing Clinical Trials Therapeutic Products Medical Device Complementary Health Products Advanced Therapy Products Scientific Advisory Office Enforcement Vigilance Compliance Tobacco Regulation Audit Licensing & Certification Copyright of the Health Sciences Authority 7

8 Regulatory Trends and Challenges Rapid Scientific Advancements Crisis and emergency preparedness Complex Supply Chain Changing Landscape Regulatory Trends & Challenges Stakeholders expectations Copyright of the Health Sciences Authority 8

9 Defining the Regulatory Approach CONVERGE and Collaborate MODERNISE Legislation CALIBRATE Risk Controls EXPLORE New Paradigms Regulatory Approach HARNESS Power of Technology LEVERAGE on Reference Agencies Copyright of the Health Sciences Authority 9

10 Modernise Legislation Legislative Restructuring Health Products Act (2007) To consolidate medicines control laws Modular approach more responsive & flexible to deal with different degrees of risk Covers regulation of health products, dealers obligations and more appropriate penalties Proactive stakeholder consultations 2007 Health Products Act 2008 Cosmetics and beyond Cell & Tissue Therapies/Complementary Health Pdts 2007 Medical Devices 2015 Therapeutic Products Copyright of the Health Sciences Authority 10

11 Calibrate Risk Controls The Regulatory Pendulum Overregulation Underregulation Smart Regulation test of reasonableness Copyright of the Health Sciences Authority 11

12 Calibrate Risk Controls Intrinsic & Extrinsic Risks Intrinsic risks Inherent risks of the product based on declared composition & intended use, e.g. ingredients, mode of administration, adverse effects Known from disclosure by applicants or on current scientific knowledge, although uncertainties still exist Pre-market control & post-approval conditions Extrinsic risks Risks not attributable to declared composition & intended use, e.g. adulteration, contamination, unsubstantiated claims Usually unknown but may be predicted from trends/experience or minimised through process controls Post-approval surveillance, audit, vigilance & enforcement Copyright of the Health Sciences Authority 12

13 Calibrate Risk Controls Risk Matrix for Medicines Rigorous High (H) Drugs More rigorous requirements for product registration & dealer licensing Pre-market Tools Intrinsic Risks (I) Quasi Drugs Cell & Tissue Therapy Complementary Health Products Active sampling & testing, compliance checks on advertisements & promotional materials Less Rigorous Low (L) Low (L) Cosmetics Extrinsic Risks (E) High (H) Passive/ Reactive Post-market Tools Active/ Proactive Copyright of the Health Sciences Authority 13

14 Calibrate Risk Controls Risk Matrix for Devices Rigorous High Class C & D More rigorous requirements for product registration and dealer licensing Pre-market Tools Intrinsic Risks Class A non-sterile Class B Class A sterile In view of the nascent nature of medical device regulations locally, the extent of extrinsic risks for medical devices are still under review & monitoring Less Rigorous Low Low Extrinsic Risks High Passive/ Reactive Post-market Tools Active/ Proactive Copyright of the Health Sciences Authority 14

15 Leverage on Ref Agencies Confidence Based Pathways (Drugs) 3 confidence-based pathways allow companies to opt for route potentially offering shortest time to market for medicines Full (from 1998) No prior approval by any drug regulatory agency Full quality, nonclinical, & clinical Total: 270 working days Abridged (from 1987) Approved by one drug regulatory agency Quality, clinical & abridged early phase clinical studies and nonclinical Total: 180 working days Verification (from 2003) Approved by two reference agencies* Reference agency assessment report Total: 60 working days Reference agencies : TGA, FDA, EMA, Health Canada, MHRA Copyright of the Health Sciences Authority 15

16 Leverage on Ref Agencies Confidence Based Pathways (Devices) Reference agencies * European Union, Health Canada, Japan MHLW, US FDA, Australia TGA Full Evaluation No prior approval by any of medical device reference agencies* Full quality, preclinical & clinical document Total: 160 to 310 working days depending on risk class of medical devices Abridged Evaluation Approval by at least one medical device reference agency* Quality, pre-clinical & clinical summary reports Total: 100 to 220 working days depending on risk class of medical devices Expedited Registration (For Class B) Review of label claims, quality and pre-clinical summary documents Total: 60 working days Immediate Registration (For Class B) Verification of * European Union, Health Canada, Japan certificates/documents MHLW, US FDA, Australia TGA Immediate registration upon successful submission Copyright of the Health Sciences Authority 16

17 Harness Power of Technology Electronic AE Reporting Online AE reporting AE reports from hospital EMRx (Critical Medical Information Store) Copyright of the Health Sciences Authority 17

18 Harness Power of Technology Global AE Report Ranking Copyright of the Health Sciences Authority 18

19 Harness Power of Technology Electronic Health Records Maximizing IT tools & electronic health records for signal detection, data mining & communication Exploring e-reporting of adverse events from private practitioners & community hospitals Leveraging on current projects for compulsory online notification of infectious diseases: CLEO (private practitioners) & CHIC (community hospitals) Secondary data analysis of EHR for active surveillance Copyright of the Health Sciences Authority 19

20 Explore New Paradigms Pharmacogenomic Studies Association between HLA- B*1502 and Carbamazepineinduced Steven-Johnson Syndrome & Toxic Epidermal Necrolysis Copyright of the Health Sciences Authority 20

21 Explore New Paradigms New Standard of Care Copyright of the Health Sciences Authority 21

22 Explore New Paradigms Adaptive Licensing Adaptive licensing (AL) approaches are based on stepwise learning under conditions of acknowledged uncertainty, with iterative phases of data gathering and regulatory evaluation. Traditional binary regulatory decisions Accelerated Approval/Condition al Market Authorization Future state: flexible patient-centered, continuous learning, controlled rollout, & use optimization Adaptive approaches to development, market access, utilization and monitoring Copyright of the Health Sciences Authority 22

23 Converge and collaborate Growing need for collaboration With globalisation and rapid advancements in technology and novel products Growing need to ensure that regulatory expertise is at the cutting edge Growing realization that no single regulatory authority has a monopoly on good science or can function in isolation Growing importance to foster closer regulatory cooperation with local and international partners to support long term efficient global approach to authorization and supervision of health products Copyright of the Health Sciences Authority 23

24 Converge and collaborate International Partnerships Beijing Red Cross Blood Center Health Canada Netherlands Medicines Evaluation Board Copyright of the Health Sciences Authority 24

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