Introduction to Inspections - World Health Organization · –1 bill more people benefitting from...
Transcript of Introduction to Inspections - World Health Organization · –1 bill more people benefitting from...
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1 Copenhagen, Denmark 24 – 27 September 2018
Introduction to Inspections
Dr Joey Gouws
PQT Group Lead: Inspections
Regulation of Medicines and other Health Technologies
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Index
Introduction
– DG message
PQT: Inspections
– Scope
Experience: National v Global responsibility
– Comparison
Way forward
Copenhagen, Denmark 24 – 27 September 2018
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Introduction WHO Director-General: Dr Tedros Adhanom Ghebreyesus
“Triple billion target”
– 1 bill more people benefitting from health
coverage
– 1 billion more people protected from health
emergencies
– 1 billion more people enjoying better health
and well-being
Access to medical products a key component
Copenhagen, Denmark 24 – 27 September 2018
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Introduction WHO Director-General: Dr Tedros Adhanom Ghebreyesus …..cont
“Medical Devices”
– An accurate diagnosis is the first step to
getting effective treatment
– No one should suffer or die because of a
lack of diagnostic services, or because
the right tests were not available."
Access to Devices a key component
Copenhagen, Denmark 24 – 27 September 2018
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Introduction….cont
• WHO estimates that 10.5% of medicines in low- and middle-income countries (LMICs) are substandard or falsified
• This is costing countries approximately US$ 30.5 billion.
NMRA are the institutions that balance these two challenges once a product has been manufactured, managing the local medicine regulatory and quality assurance system.
WHO PQT Programme: Initiative
Copenhagen, Denmark 24 – 27 September 2018
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Regulation of
Medicines
and other
Health
Technologies
Scope of PQT: Inspections
Medicines
• Traditional products
• API
• Vaccines
• Snake antivenom
• Biosimilars
• Clinical trials / BE
studies
• Laboratories
QC
Biological
Vector control
• Sprays
• Mosquito nets
Devices
• IVDs
• Training
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Experience: National versus Global responsibilities
National Global
54 millj people 3 Billj
Vulnerable (poor of the poor)
NRA: Medicines, MD WHO: PQT - LMIC
Medicines, MD, Vector
Local sites & international sites –
constraints on resources
International sites- constraints on
resources
CTD and eCTD
• Variety of products
CTD
• Predefined areas
Common goal:
Ensure quality, safe effective and products of high performance
Copenhagen, Denmark 24 – 27 September 2018
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Common: Aim of Inspections
A clear objective valid for all inspections and audits
1.Protecting patients
2.Assuring the overall state of
control
of manufacturing / distribution process Capability
of production and control procedures Adequacy
of equipment and facilities Suitability
of the quality management system Effectiveness
Copenhagen, Denmark 24 – 27 September 2018
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Common: Manufacturing and Supply of Medicines
Occurs Across Complex Global Supply Chain
Country specific regulatory systems & WHO guidelines
enforcing GMP/GDP
Copenhagen, Denmark 24 – 27 September 2018
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Common: Inspection workload
Seek opportunities to better use resources
Manufacturing sites
Copenhagen, Denmark 24 – 27 September 2018
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Where the world is going and what we should do next?
Need to reflect on objective of our task
– WHO: 184 member states
– PIC/S: 52 active participating
authorities
How better to execute our responsibilities:
– What opportunities exist?
Copenhagen, Denmark 24 – 27 September 2018
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17 Approaches to More Efficient Inspectional
Oversight
Fulfill Inspectorate decision obligations
Trust
4. Reliance
5. Recognition
2. Desk Top Review
1. On-site inspection
3. Cooperation
Kn
ow
led
ge
6. Delegation
Copenhagen, Denmark 24 – 27 September 2018
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Medical Devices: ICDRA 2016 (Cape Town)
Recommendations: – Model regulatory framework for medical devices:
how to take steps for successful implementation
– Create a technical working group on medical devices
– Collaborate with partners • International medical device regulators forum (IMDRF)
• Pan African harmonization working party (PAHWP)
• Asian harmonization working party (AHWP)
– in strengthening medical device regulatory functions
– capacity building for regulators on medical devices
Copenhagen, Denmark 24 – 27 September 2018
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Medical Devices
Essential Device List - 113 products - published 15 May
2018
– 58 tests are listed for detection and diagnosis
of a wide range of common conditions
– 55 tests detection, diagnosis and monitoring
of "priority" diseases
• HIV, TB, malaria, hepatitis B and C, HPV and
syphilis.
– IVD Web portal: launch date 30 Sept 2018
Copenhagen, Denmark 24 – 27 September 2018
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Medical Devices: Way Forward
Collaboration with partners:
– International medical device regulators
forum’s (IMDRF)
– Medical Devices Single Audit
Program (MDSAP)
to minimize the inspection burden on the manufacturers by
enabling the use of MDSAP audits instead of WHO
inspections
Copenhagen, Denmark 24 – 27 September 2018
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Medical Devices: Way Forward …cont
Regulatory System Strengthening (RSS) and unification of
the Global Benchmarking Tool will contribute to:
– the optimal resources mobilization
– greater consistency in standards and
approach
– improved outcomes
– less burdensome interventions for the
regulatory authorities
Copenhagen, Denmark 24 – 27 September 2018
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Medical Devices: Way Forward…cont
Capacity building of regulators
– training to regulators in inspection of medical
devices ( IVDs in particular) – the latest such
training was provided to CFDA and CFDI
inspectors from 20-24 August 2018.
Copenhagen, Denmark 24 – 27 September 2018
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Way forward
– Rise awareness at NRA on tools available
• Collective collaboration by:
Leveraging existing harmonisation procedures
Greater reliance on other inspectorates
Greater dialogue amongst inspectorates
Increase Co-inspections
• Share resources
– Allow industry to continue manufacturing:
• Availability of health products for unmet needs
Copenhagen, Denmark 24 – 27 September 2018
Quality matters, access matters, patients
matter
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Interagency Consultation on LP 08 June 2018 Geneva
Thank you Joey Gouws
PQT: Group Lead Inspections
Regulation of Medicines and other Health Technologies
gouwsj:who.int