introduction to inspections - world health organization · –1 bill more people benefitting from...

1 Copenhagen, Denmark 24 – 27 September 2018

Introduction to Inspections

Dr Joey Gouws

PQT Group Lead: Inspections

Regulation of Medicines and other Health Technologies

Index

Introduction

– DG message

PQT: Inspections

– Scope

Experience: National v Global responsibility

– Comparison

Way forward

Copenhagen, Denmark 24 – 27 September 2018

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

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

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

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

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

8

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

9

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

10

Common: Inspection workload

Seek opportunities to better use resources

Manufacturing sites

Copenhagen, Denmark 24 – 27 September 2018

14

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

14

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

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

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

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

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

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

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

23

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