WHO Pharmaceutical Activities: Regulation of … Summit of Heads of Medicines Regulatory Agencies Symposium WHO Pharmaceutical Activities: Regulation of Medicines and other Health

12th Summit of Heads of Medicines Regulatory Agencies Symposium

WHO Pharmaceutical Activities: Regulation of Medicines and other Health Technologies

Emer Cooke, Head, Regulation of Medicines and other Health Technologies

27 October 2017 Kyoto, Japan

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1. Health for all 2. Health emergencies

3. Women, children and adolescents

4. The health impacts of climate and environmental change

5. A transformed WHO

Director General’s

5 priorities

WHO/EMP/RHT 27 October 2017, Kyoto

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VISION: A world where every child, man and woman

has access to the quality essential medicines,

vaccines and other health products they need to lead

a healthy and productive life.

Programme of Essential Medicines and Health Products

MISSION: To support the WHO Member States to

improve and sustain access to quality medicines

and health products to achieve Access 2030 goals

and universal health coverage (UHC).


4WHO/EMP/RHT 27 October 2017, Kyoto

New Cluster “Drug Access, Vaccines and Pharmaceuticals”

Assistant Director General: Dr. Mariângela Batista Galvão Simão

Department of Essential Medicines and Health Products (EMP)

Director: Sue Hill

Technologies Standards and Norms (TSN)

Regulatory Systems Strengthening (RSS)

Prequalification Programme (PQT)

Safety and Vigilance (SAV)

Regulation of Medicines and other Health Technologies

(RHT)

Head: Emer Cooke

Innovation, Access and Use

• Innovation/research & Development• Intellectual property, •Evidence-based selection of Model List of Essential Medicines

•Pricing, Health technology assessment (HTA)

•Procurement and supply chain management

• Improved use of medicines and health products

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“Towards Access 2030”

To Increase Access to Essential,

High-Quality, Safe, Effective and

Affordable Medical Products

Guardian

Strengthening regulatory capacity and practices to

ensure the quality, safety and efficacy of products and improve the efficiency of

regulatory system to secure health gains

Facilitator

Supporting needs-based innovation and reinforcing

health product selection, use, procurement and supply

systems to increase access

Two strategic roles of EMP

http://www.who.int/medicines/publications/towards_access2030/en/

RHT


http://www.who.int/medicines/publications/towards_access2030/en/

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•Focus on increasing access – e.g pricing, preventing shortages

•Evidence-based selection of Model List of Essential Medicines (EML)

•Pricing, Health technology assessment (HTA) “Fair Pricing Forum”

•Procurement and supply chain management

•Contributing to the prevention of Antimicrobial Resistance

Facilitator role – some examples


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• Mapping of existing in vitro diagnostics

• Development of a model list of Essential in-vitro diagnostics

• Review of the antibiotic chapters in the Essential Medicines List

o ACCESS: to be available at all times as treatments for a wide range of common infections.

o WATCH: as first- or second-choice treatments for a small number of infections.

o RESERVE: considered last-resort options, and used only in the most severe circumstances

when all other alternatives have failed, such as for life-threatening infections due to

multidrug-resistant bacteria.

• Stewardship policies to support this

• Regulatory support needed

Global Action Plan on AMR: Objective 4: Optimize the Use of Antimicrobial Agents

HMRA Summit –

AMR: 24 October

2017

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“Develop the economic

case for sustainable

investment that takes

account of the needs of all

countries, and increase

investment in new

medicines, diagnostic

tools, vaccines, and

other interventions”

Global Action Plan on AMR: Objective 5:

WHO priority pathogens list

for R&D of new antibiotics

HMRA Summit – AMR: 24 October 2017

Priority 3: MEDIUM• Streptococcus pneumoniae

• Haemophilus influenzae

• Shigella spp.

Priority 2: HIGH• Enterococcus faecium

• Staphylococcus aureus

• Helicobacter pylori

• Campylobacter spp.

• Salmonellae

• Neisseria gonorrhoeae

Priority 1: CRITICAL• Acinetobacter baumannii

• Pseudomonas aeruginosa

• Enterobacteriaceae

http://www.who.int/mediacentre/news/releases/2017/ba

cteria-antibiotics-needed/en/

http://www.who.int/mediacentre/news/releases/2017/bacteria-antibiotics-needed/en/

“Guardian role” across RHT’s main activities

Norms

Standards

Regulatory Sys Strengthening

Prequalification

Safety &

Vigilance

Establish/maintain international standards Promote unified standards, as well as a global nomenclature

Strengthen NRAs for capacity building/efficiencies, promote harmonization, reliance, best practices & integrate framework for new products

Assure safe, effective & quality health products for public health challenges

Respond to and minimize health risks from medical products by improving product safety & vigilance and expanding information systems C

ros

s C

utt

ing

Ch

all

en

ge

s

•AMR

•Benchmarking

tools

•Data integrity

•Emergency

preparedness

•Environmental

issues

•Local

production

•NCDs

•Paediatric

medicines

•Shortages

•Substandard

& Falsified

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Created in response to procurement agencies and WHO Member States needs to ensure that products supplied through these agencies are consistently safe and effective under conditions of use in resource limited countries

Prequalification Team (PQT):

Technical assistance to manufacturers, NRAs and other stakeholders

Inspections of manufacturing sites

Facilitation of National regulatory approval for Dx, Rx, VCP & Vx

Laboratory evaluation & testing of Dx, Rx, VCP & Vx

Laboratory prequalificationof Rx quality control laboratories

&

Diagnostics

(Dx)

in-vitro diagnostics &

male circumcision

devices

Medicines

(Rx)

finished pharmaceutical

products & active

pharmaceutical ingredients

Vaccines

(Vx)

vaccines, immunization

devices & cold chain

equipment

Vector Control

Products (VCP)

finished products & active

ingredients


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• All product streams involve screening, assessment, inspection,

laboratory testing (to a greater or lesser degree)

• Abridged procedures for all product streams

• Current focus on Malaria, TB, HIV, Reproductive Health and

Neglected Tropical diseases

• Can model be used for non-communicable disease treatments?

• What would need to change?

• What impact does prequalification have on time to registration

in countries?

Prequalification updates and challenges


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Collaborative Registration Procedure (CRP): solving the time to registration in countries

Procedure in

development

Ongoing

discussions with

NRAs

Diagnostics

WHO PQ shares the reports that served as the basis for the

prequalification decision, so that NRAs do not conduct assessment

and inspections

National registration based on PQT evaluation

New Procedure based on registration in other countries endorsed

Started in 2012

As of December

2016:

30 countries

participating

183 registrations in

20 countries for 73

different products

Medicines

Procedure

published in 2007,

harmonized for

medicines and

vaccines as of 2014

In 2015:

Adopted by expert

committee (ECBS)

Vaccines

Principles


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As at 12 May 2017

* AFTER Including regulatory time and applicant time

81.0

93.0 73.0 74.5

93.0

79.0

0.010.020.030.040.050.060.070.080.090.0

100.0

Days*

Median time to registration via CRP:Before and After CRPBefore CRP – 2 months to 10 years

Days


The 5th CRP Annual Meeting

Accra, Ghana, 25 - 26 November 2017

Side meeting on CRP of Oral Cholera vaccine

with participation of all current involved

authorities


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• Requires basic functionality of National

Regulatory Authorities

• Investment in regulatory systems strengthening

essential

• Increased focus on pharmacovigilance and post-

marketing surveillance competences

Impressive results from CRPalready seen

But to build collaborative procedures,


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Norms and

standards

Medical devices

including

Diagnostics

ICDRA

International

and regional

collaboration

Networks

WHO

PQ program

World Health Assembly Resolution 67.20What WHO should do

Capacity building

in developing

countries

Regulation of

complex

biological

Health system

strengthening



World Health Assembly Resolution 67.20 requests WHO to

support Member States upon their request in the area of

regulatory system strengthening, including, as appropriate,

by continuing to:

Evaluate national regulatory systems

Apply WHO evaluation tools

Generate and analyze evidence of regulatory system performance

Facilitate the formulation and implementation of Institutional Development Plans (IDPs)

Provide technical support to national regulatory authorities and governments

Regulatory Systems Strengthening (RSS)


• More effective use of overall resources

• Better outcomes and impact through coordinated action at regional

and/or country level

• Wealth of expertise available across the member organizations

• Greater capacity and sustainability

• Sharing and adoption of best practices

How can we get help to achieve this goal?Coalition of Interested Partners (CIP)

Build a framework to achieve better coordination, efficiency

and outcomes in regulatory strengthening activities in the

same target Member States or regions to achieve better public

health outcomes

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“Good Regulatory Practices (GRP) are internationally recognised processes,

systems, tools and methods for improving the quality of regulations.

WHO guidelines under development

Responds to requests from Member States for guidance on how to develop legal

frameworks

Foundational document that applies internationally accepted principles of GRP to

the regulation of medical products

Relevant to all regulators, irrespective of resources and system

(centralized/decentralized/network)

Promoting Good Regulatory Practices- including “Reliance concepts”


Principles of GRP

Legality Impartiality Consistency

Proportionality Flexibility Effectiveness

Efficiency Clarity Transparency

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• Lack of coordinated emergency regulatory processes

o Link regulatory processes with overall national preparedness

planning for public health emergencies

• Weakness of drug regulatory systems and lack of capacity

o Strengthen regulatory collaboration and capacity

• Limited capacity and experience in stakeholder communication

o Need for guidance in communicating with the media and public

• Poor engagement of product developers with affected regulators

• Weakness in regulation of supply chains

o Need to minimize entry of substandard and falsified products in

supply chains

Crisis Management -Dealing with Public Health Emergencies:Some of the gaps in regulatory preparedness


Substandard and Falsified Medicines: How to better Protect Public Health?

Member State Mechanism

Political support

Promote access to affordable,

safe, efficacious, and quality

medical products

Effective Member States’

collaboration and coordination

Socio-economic study

POLITICAL RESPONSE

Global Surveillance and Monitoring System

Immediate technical and

operational support

National Regulatory Authority

(NRA) capacity building and policy

guidance

Improve current knowledge for in

depth landscape, SWOT analyses,

etc

OPERATIONAL RESPONSE

Preventing Substandard and Falsified Medical Products: Prevent – Detect –Respond

WHO/EMP/RHT| 12th Summit HMRA, Kyoto, Japan 23

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• WHO is committed to contribute to access to safe, effective and quality

medical products for every patient

• This can only be achieved with the help of stakeholders and member

states

• WHO encourages collaboration at regional and global level between

member states for efficient use of resources

• Needs to adapt to a changing world – countries at the centre – adapting

to new technologies

• Pre-market safety assessment and post market surveillance are equally

important, specifically substandard and falsified product require full

attention of every stakeholder and authority

• ICMRA members have key roles to play

Key messages


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• Source of regulatory and

scientific expertise

• Contribution to technical

activities

• Sparring partner – sounding

board

• Honest and constructive

feedback

• Mapping international activities

to inform new developments at

WHO

How can ICMRA help achieve the WHO Vision?


requiresan integrated

approachWith all stakeholders

Access to quality

medicines and other

health technologies

Documents

WHO Pharmaceutical Activities: Regulation of … Summit of Heads of Medicines Regulatory Agencies Symposium WHO Pharmaceutical Activities: Regulation of Medicines and other Health