who pharmaceutical activities: regulation of … summit of heads of medicines regulatory agencies...
TRANSCRIPT
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
2
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
3
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).
WHO/EMP/RHT 27 October 2017, Kyoto
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
5
“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
WHO/EMP/RHT 27 October 2017, Kyoto
6
•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
WHO/EMP/RHT 27 October 2017, Kyoto
7
• 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
8
“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/
“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
10
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
WHO/EMP/RHT 27 October 2017, Kyoto
11
• 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
WHO/EMP/RHT 27 October 2017, Kyoto
12
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
WHO/EMP/RHT 27 October 2017, Kyoto
13
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
WHO/EMP/RHT 27 October 2017, Kyoto
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
WHO/EMP/RHT 27 October 2017, Kyoto
15
• 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,
WHO/EMP/RHT 27 October 2017, Kyoto
16
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
WHO/EMP/RHT 27 October 2017, Kyoto
17WHO/EMP/RHT 27 October 2017, Kyoto
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)
18WHO/EMP/RHT 27 October 2017, Kyoto
• 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
19
“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”
WHO/EMP/RHT 27 October 2017, Kyoto
Principles of GRP
Legality Impartiality Consistency
Proportionality Flexibility Effectiveness
Efficiency Clarity Transparency
21
• 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
WHO/EMP/RHT 27 October 2017, Kyoto
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
24
• 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
WHO/EMP/RHT 27 October 2017, Kyoto
25
• 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?
WHO/EMP/RHT 27 October 2017, Kyoto