challenges of biomedical advancementmodular approach – more responsive & flexible to deal with...
TRANSCRIPT
Copyright HSA 2010 1
Challenges Of Biomedical Advancement Evolving Role Of The Regulator
1 December 2010
Dr John LimChief Executive Officer
Health Sciences AuthoritySingapore
About HSA
Copyright HSA 2010 3
A Statutory Board of the Ministry of Health
The Singapore Public Service
Copyright HSA 2010
•Clinical Trials •Therapeutic Products • Complementary Health Products • Audit & Licensing• Vigilance & Compliance • Enforcement & Prosecution
• Blood Banking &Transfusion Services
• Hemovigilance
• Forensic Medicine • Forensic Science • llicit Drugs & Toxicology • Pharmaceutical Testing• Food Safety Testing• Chemical Metrology
Options for new & greater synergies across Groups
Functions & Roles of Health Sciences AuthorityFunctions & Roles of Health Sciences Authority
4
Challenges Of Regulators
Copyright HSA 2010
1. Crisis - Whole Of Govt Effort1. Crisis - Whole Of Govt Effort
6
MOH(Ops, CC,
etc)
HSA
Ministries and
Agencies
CommHCPs
HC Institut-
ions
HPB
Pandemic Readiness & Response Plan
Vaccines selection & approval
Secure vaccine stocks
Vaccination Programme
Postmarketing Surveillance
HCP & Public Education & Comms
H1N1
Copyright HSA 2010
2. Public Safety, Expectations & Access2. Public Safety, Expectations & Access
Copyright HSA 2010
Building Biomedical R&D Capabilities
Before 2000
Institute of Molecular & Cell Biology (IMCB)
200320012000
Genome Institute of
Singapore (GIS)Bioprocessing Technology
Institute (BTI)*
Institute of Bioengineering & Nanotechnology
(IBN)
BioinformaticsInstitute (BII)
Phase 1 (2000‐2005)
Singapore Stem Cell Consortium
(SSCC)
2005
Singapore Bioimaging Consortium
(SBIC)
2006 2007
Institute of Medical
Biology (IMB)^Singapore Institute for Clinical
Sciences (SICS)
Singapore Immunology
Network (SIgN)
Experimental Therapeutics Centre (ETC)
Phase 2 (2006‐2010)
3. Building Biomedical R&D Capabilities3. Building Biomedical R&D Capabilities
Copyright HSA 2009 9
Evolving Role Of The RegulatorEvolving Role Of The Regulator
Rapid development in translational researchNeed to enhance research & clinical trials infrastructureEmergence of new diseases & products
Basic Translational Clinical Service Delivery
Biomedical ResearchBench Bed
A*STAR MOH & HSAGAP
Regulators - What Do We Need To Do?
Copyright HSA 2010 11
Key Questions for RegulatorsKey Questions for Regulators
How can a regulator, with limited resources, innovate to meet expectations?
How can a regulator ensure high internal efficiency and effectiveness?
How can a regulator meet the challenges of a highly globalised industry?
How can a regulator meet the challenges of a fast-paced biomedical sector?
11
Copyright HSA 2010
Pre-Market Evaluation Routes for New Drugs
* Reference regulatory agencies refer to US FDA, Health Canada, UK MHRA, Australian TGA, EMEA
Pre-submissionconsultation
Full evaluation & Regulatory Decision
Product approved by one drug regulatory agency
Evaluation & Regulatory Decision based on assessment report by benchmark regulatory agency
Full Evaluation
Abridged Evaluation
Verification
Abridged evaluation & Regulatory Decision
Product approved by reference regulatory agencies*
Product yet to beapproved by any regulatory agency
a. Innovation – HSA’s 3-route Systema. Innovation – HSA’s 3-route System
12
Risk-Based Approach
Copyright HSA 2010 13
b. Ensuring Efficiency & Effectivenessb. Ensuring Efficiency & Effectiveness
Appropriate legislative framework necessary for regulatory effectiveness
New Health Products Act■ Modular approach – more responsive & flexible to deal with different
degrees of risk
■ Covers regulation of health products, dealers’ obligations and more appropriate penalties
■ Opportunity to review process, licensing requirements & enforcement penalties
Review of internal processes and structureBusiness Process Re-engineering■ Opportunity to review , re-direct & refresh
13
Copyright HSA 2010 14
c. Meeting Challenges Of A Highly Globalised Industry
c. Meeting Challenges Of A Highly Globalised Industry
Aim To Be A Networked Regulator
Key member of regulatory communityRegional collaborations, eg ASEAN initiativesMOUs – sharing of confidential information, technical exchanges, training Consortium for work-sharing, e.g. joint GMP inspections, parallel reviews
Initiatives to engage key stakeholdersCollaboration with INTERPOL in anti-counterfeiting1st EDB – Asian Healthcare ForumCollaboration with MIT-NEWDIGS
14
Copyright HSA 2010 15
d. Meeting Challenges Of A Fast-paced Biomedical Sector
d. Meeting Challenges Of A Fast-paced Biomedical Sector
A Networked Regulator
Environmental Scanning Anticipating and planning for new science and technology
Risk ManagementRecognising areas of shortcoming and mitigating risks
Developing Thought Leadership In Regulatory Science
HSA AcademyMIT-NEWDIGS Project to improve upon current drug development process
15
Copyright HSA 2010
Process Improvements – Prioritization Approach Traditional
Sharing of Information e.g post-market information
Technical Collaborations
Memoranda of Understanding (bilateral; tripartite)
Mutual Recognition Agreements
Staff Exchanges
Possible Ways Forward
Mapping exercise of key global cooperation initiatives
Micro-consortia
Worksharing
Innovative projects in regulatory science
Platforms of CollaborationPlatforms of Collaboration
Conclusion
Copyright HSA 2010 18
ConclusionConclusionTo manage the various challenges, we need to develop
Better horizon scanning
Emerging diseases and technological developments
Opportunities to improve current processes
Better resource planning
Develop sufficient talent to manage existing/emerging challenges and opportunities
Reviewing/eliminating existing processes that are redundant, or leveraging on IT
Better coordination among stakeholders globally
For better efficiency and effectiveness
Better change management
E.g. significant changes to the current drug development process
18
Copyright HSA 2010
Thank You
19