DELIVERING QUALITY-ASSURED MEDICAL PRODUCTS FOR ALL - 2019-2023 WHO's five-year plan to help build
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DELIVERING
QUALITY-ASSURED
MEDICAL PRODUCTS
FOR ALL
2019–2023
WHO’s five-year plan to help build
effective and efficient regulatory systems
WHO Action Plan V10.indd 1 01/07/2019 09:31
WHO Action Plan V10.indd 2 01/07/2019 09:31
DELIVERING
QUALITY-ASSURED
MEDICAL PRODUCTS
FOR ALL
2019–2023
WHO’s five-year plan to help build
effective and efficient regulatory systems
WHO Action Plan V10.indd 3 01/07/2019 09:31
© World Health Organization 2019. All rights reserved.
The document may not be reviewed,
abstracted, quoted, reproduced,
transmitted, distributed, translated or
adapted, in part or in whole, in any form
or by any means without the permission
of the World Health Organization.
Design and layout: Sophie Hollies
Printed by the WHO Document Production Services, Geneva, Switzerland
WHO Action Plan V10.indd 4 01/07/2019 09:31
Table of Contents
Foreword v
Abbreviations vi
Executive summary 1
Introduction 5
Major regulatory challenges and responses 9
Strategic priorities and goals 18
• An essential support in the drive towards UHC 19
• Key principles: collaboration and reliance 19
• Strategic Priority 1: Strengthen country and regional
regulatory systems in line with the drive towards UHC 20
• Strategic Priority 2: Increase regulatory preparedness
for public health emergencies 24
• Strategic Priority 3: Strengthen and expand WHO
requalification and product risk assessment processes 26
• Strategic Priority 4: Increase the scope and impact of
WHO’s regulatory support activities 28
An ambitious agenda 30
Annex A: Strategic priorities and goals 32
Annex B: Prequalification timeline and Key Performancec
Indicators (KPIs) 35
WHO Action Plan V10.indd 5 01/07/2019 09:31Foreword Abbreviations Executive Introduction Challenges Strategic An Ambitious Annex A Annex B
Summary & Responses Priorities Agenda
Foreword
People who work in health care Our record in this area speaks for differing regulatory standards and
expect the products they use to work itself. There are many achievements requirements.
as described on the box – in fact, to to point to, but the one that stands
actually be what is described on the out for me is a national success story. Rather than simply wringing our
box. The fundamental issue is trust: just With WHO’s robust guidance based hands about this challenge, WHO is
as patients need to be able to trust in on assessment made by our Global leveraging globalization in a positive
our expertise, health workers need to be Benchmarking Tool, the United Republic way. Partnering with regional and
able to trust that products they prescribe of Tanzania has become the first country national networks all over the world, we
actually do what they are meant to do: in Africa to achieve a well-functioning promote a collaborative reliance model
prevent illness and improve people’s regulatory system for medical products. for regulatory authorities. Collaboration
health. I congratulate Tanzania and our helps such authorities to cut costs and
That, in essence, is what we aim for Tanzanian colleagues, and look forward reduce the time it takes to get sorely
in this five-year plan, in a context of to many more countries’ commitment to needed medical products to patients;
increasing globalization, technological achieving this status over the next five reliance allows the expertise and
advance, changing disease patterns years. experience of trusted national regulators
and demographics, and the disturbing to be shared and their benefits amplified.
prevalence of substandard and falsified Another source of pride is the quiet but
products. steady work of the WHO Prequalification This is the ethos and approach of our
Programme. Over the years, it has five-year plan. With its four strategic
Good regulatory systems, providing contributed to treating millions of people priorities for regulatory support, it is
oversight of health products throughout with quality, cost-effective medicines, ambitious but feasible.
their lifecycle from the laboratory to the including HIV treatments, as well as to I have great confidence in the enthusiasm
health facility, are the linchpin of quality protecting millions of children worldwide and abilities of my colleagues at WHO,
prevention, diagnosis and treatment. from vaccines-preventable deseases the energy and receptiveness of the
They are an essential part of WHO’s through safe, effective and quality national regulatory authorities we work
drive towards universal health coverage vaccines. The same goes for our core with, and the diverse ways in which our
(UHC) and a key contribution to reaching function of setting standards for medical international partners support us. With
the “triple billion” target (1 billion more products, which continues to ensure that their cooperation and a clear plan to
people benefitting from universal health manufacturers and regulators have clear work from, I look forward to the next
coverage, 1 billion more people better norms to adhere to and a global point of five years.
protected from health emergencies, and reference. This is particularly important
1 billion more people enjoying better in an increasingly globalised world,
health and well-being) set by WHO’s where medical products are sourced
13th General Programme of Work. from different countries with sometimes
Dr Mariângela SIMÃO
Assistant Director-General
Access to Medicines, Vaccines
and Pharmaceuticals
Geneva, 2019
V Regulatory Action Plan 2019-2023
WHO Action Plan V10.indd 6 01/07/2019 09:31Abbreviations
ADRs Adverse Drug Reactions IDP Institutional Development Plan
AEFI Adverse Events Following Immunization IGAD Intergovernmental Authority on
Development
AEIVD Adverse Events related to IVDs
IMDRF International Medical Device Regulators
AEMD Adverse Events related to Medical
Forum
Devices
IPRP International Pharmaceutical Regulators
AMRH African Medicines Regulatory
Programme
Harmonization
IVDs In vitro diagnostics
APEC Asia-Pacific Economic Cooperation
KPI Key Performance Indicator
API Active Pharmaceutical Ingredient
LMICs Low- and Middle-Income Countries
ASEAN Association of Southeast Asian Nations
ML3 Maturity Level 3
AVAREF African Vaccine Regulatory Forum
MSM Member State Mechanism
CARICOM Caribbean Community
NRAs National Regulatory Authorities
CIP Coalition of Interested Partners
PHEs Public Health Emergencies
CPP Certification of Pharmaceutical Products
PIC/S Pharmaceutical Inspection Convention
CRP Collaborative Registration Procedure
and Pharmaceutical Inspection Co-
EAC East African Community operation Scheme
ECOWAS Economic Community of West African PIDM Programme for International Drug
States Monitoring
EDL Essential Diagnostics List PPCs Preferred Product Characteristics
EML Essential Medicines List PQ Prequalification
ERP Expert Review Panel PSPQ Programmatic Suitability for
Prequalification
EUAL Emergency Use Assessment and Listing
(replaced by EUL) SADC Southern African Development
Community
EUL Emergency Use Listing
SBPs Similar Biotherapeutic Products
FPP Finished Pharmaceutical Product
SEARN South East Asia Regulatory Network
GBT Global Benchmarking Tool
SF Substandard and Falsified
GMP Good Manufacturing Practices
SMART Specific, Measurable, Achievable,
GPW13 WHO 13th General Programme of Work
Relevant, Time-Bound
GSMS Global Surveillance and Monitoring
TPPs Target Product Profiles
System
SRAs Stringent Regulatory Authorities
GVSI Global Vaccine Safety Initiative
UHC Universal Health Coverage
HICs High-income Countries
UNICEF United Nations Children’s Fund
ICDRA International Conference of Drug
Regulatory Authorities VCPs Vector Control Products
ICH International Council for Harmonisation WHOPES WHO Pesticide Evaluation Scheme
of Technical Requirements for
WLAs WHO Listed Authorities
Pharmaceuticals for Human Use
ICMRA International Coalition of Medicines
Regulatory Authorities
2019-2023 Regulatory Action Plan vi
WHO Action Plan V10.indd 7 01/07/2019 09:31Executive
Summary
WHO/Shutterstock
WHO’s 2019–2023 Plan to help build effective and efficient
regulatory systems is designed to help national regulators
to deliver regulation that protects the public while enabling
timely access to quality products and encouraging innovation.
Closely aligned with WHO’s 13th General Programme of
Work (GPW13), this Plan prioritizes regulatory initiatives to
help our Member States increase access to universal health
coverage (UHC), support health emergency responses,
and promote healthier populations. Building on its current
activities, annual work plans with specific deliverables and
key performance indicators (KPIs) will be prepared based on
four strategic priorities.
1
1 Action plan 2019-2023
WHO Action Plan V10.indd 1 01/07/2019 09:31Foreword Abbreviations Executive Introduction Challenges Strategic An Ambitious Annex A Annex B
Summary & Responses Priorities Agenda
Executive Summary
Strategic Priority 1: Strengthen country and regional
regulatory systems in line with the drive towards UHC
Many countries lack adequate maturity commensurate with a stable, features such as regulatory provisions
investment of resources (financial well-functioning regulatory environment for reliance, a fast-tracking registration
and expertise) in regulatory systems, for medicines, medical products and process, and an effective and adapted
resulting in weak regulation of vaccines. Of these, seven countries pharmacovigilance system.
medicines, vaccines, biotherapeutics, will achieve this by incorporating the
blood and blood products, in vitro concept of “reliance” on work done by Strategic Priority 3: Strengthen and
diagnostics (IVDs) and medical devices. other advanced regulators and through expand WHO prequalification and
People in these countries thus face WHO’s collaborative registration product risk-assessment processes
an unnecessary barrier to accessing procedure (CRP). Reliance will be
ck
the essential medicines and medical applied over the entire product life- Many populations in the poorest
products they need to lead healthy cycle, including testing, vigilance and countries now have increased access
lives. Solutions to this barrier have to post-market surveillance. Furthermore, to life-saving vaccines, quality-assured
be tailored to the diverse needs of at least 30 additional countries will have medicines for HIV, TB, malaria and
countries: a country that imports all of introduced a risk-based approach for women’s health, reliable IVDs for HIV
its essential medicines and diagnostics regulating medical devices, including and malaria, and effective vector control
will have different regulatory needs than IVDs, as reflected in the WHO Global products (VCPs). Procurement agencies
a country with significant manufacturing Model Regulatory Framework for and governments have come to rely on
capacity and export potential. medical devices. recommendations included in WHO
Prequalification Lists regarding ensured
Solutions should also incorporate Strategic priority 2: Increase quality products. It is therefore critical to
internationally-recognized, science- regulatory preparedness for public ensure that WHO continues to operate
based and harmonized standards, along
health emergencies an efficient and effective Prequalification
with increased collaboration among
Programme.
regulators to strengthen regulatory
Responding to a public health
decision-making. As well, solutions have
emergency – for example, an emerging In five years, WHO will have expanded
to address well-documented regulatory
infectious disease – requires decision- the scope of prequalification to cover
challenges such as the ubiquity of
making in a context that is different products important for additional
substandard and falsified (SF) medical
than “business as usual.” Being prepared priority diseases. At the same time,
products, underreporting of adverse
with the necessary plans and tools, and new routes to prequalification listing will
reactions to medicines and other health
being rehearsed, is just as essential for be developed to ensure optimal use of
technologies, and the limited global
regulators as for other stakeholders the processes, e.g. expanding reliance
capacity to regulate medical devices.
in an emergency situation. WHO has on advanced regulators identified
WHO uses standardized tools to
considerable experience in helping as WHO-Listed Authorities (WLAs).
objectively assess regulatory needs,
regulators improve and test their New listings will be introduced using
and has the necessary experience to
systems’ preparedness so that they are risk-based approaches such as Expert
help countries improve their regulatory
sufficiently robust and responsive in a Review Panels (ERPs) and Model Quality
systems, working in collaboration with
public health emergency. However too Assurance Systems, in order to support
a variety of partners. Based on defined
many countries remain inadequately time-limited procurement and existing
criteria in the Global Benchmarking Tool
prepared. risk-based approaches. Training on
(GBT), this Plan aims for 50 countries to
regulation through reliance will also be
have improved their regulatory systems
In five years, WHO expects that at enhanced. As it did in June 2018 with
by 2023 as a result of technical assistance
least 10 additional LMICs will have the launch of a pilot for prequalification
provided by WHO. Current data
improved their regulatory infrastructure of selected biotherapeutic products – a
estimates that a total of 24 additional
to address the specific challenges of
countries will reach a level of system
public health emergencies, adopting
2019-2023 Regulatory Action Plan 2
WHO Action Plan V10.indd 2 01/07/2019 09:31Foreword Abbreviations Executive Introduction Challenges Strategic An Ambitious Annex A Annex B
Summary & Responses Priorities Agenda
An ambitious agenda
step towards making some of the most WHO is already heavily invested and active in many of the relevant
expensive cancer treatments more
widely available in low and middle- areas, and it is important to note that all core activities will be
income countries – WHO will expand maintained. For example, the Prequalification Programme enables
the types of products that are eligible approximately US$ 3.5 billion per year in donor procurement of quality,
for prequalification. Products in the
WHO’s Essential Medicines List (EML, safe and efficacious products, roughly half of which accounted for by
including vaccines) or the Essential vaccines. The impact of prequalification goes considerably beyond
Diagnostics List (EDL) will be taken into the donor-funded market, as countries also rely on listing of products
consideration.
by the Programme to guide national self-procurement decisions.
Strategic Priority 4: Increase the
scope and impact of WHO’s Though ambitious, the 2019-2023 Plan is feasible, consolidating
regulatory support activities and optimizing the WHO’s regulatory support work from 2013 to
WHO headquarters will provide 2018. That Member States recognize the importance of addressing
leadership in planning, coordination the challenges for regulators is reflected in World Health Assembly
of delivery, and generating/pooling of Resolution 67.20, which calls for global political support to
resources across the Organization’s
regulatory support activities. WHO strengthen regulatory authorities and regulatory processes around
will develop annual action plans, and the world. Such high-level support for strengthening regulatory
will implement and publish specific, systems represents a major opportunity to advance a clear agenda,
measurable, achievable, relevant,
time-bound (SMART) indicators to and to implement the plans presented in the following pages.
permit monitoring of progress towards
objectives and goals. Relevant key
performance indicators will be defined
to measure the impact of the action
plan. Priority will also be given to
collaborative and integrated approaches
in regulatory support activities across
WHO (Headquarters, Regional Offices
and Country Offices), coupled with
greater alignment with WHO disease
programmes. There will also be more
effective coordination with external
partners. Impact measurement will
become a core activity, with metrics
applied across activities and processes
and greater use of mechanisms to
enhance accountability to stakeholders.
In five years, WHO will have reinforced
how it monitors and reports on its impact
on regulation and access to medicines
and health products.
3 Regulatory Action Plan 2019-2023
WHO Action Plan V10.indd 3 01/07/2019 09:31IMPROVING ACCESS TO
IMPORTANT MEDICAL PRODUCTS
In 2017, The Lancet’s Commission on Essential Medicines reported on global
progress towards improving access to the most important medical products.
“
The report stated,
The Commission believes
that achieving sustainable
development requires
concerted efforts to improve
the quality and safety
of essential medicines,
though building appropriate
regulatory system a part of
”
health systems.
Wirtz et al, Essential Medicines for Universal
Health coverage. Lancet. 2016;388
It went on to list five crucial areas of opportunity
for improving the quality and safety of essential
medicines:
Expand international regulatory
convergence and harmonisation
Broaden the WHO/UN Prequalification
Programme
Establish good procurement practices
at all levels
Promote surveillance of product quality
and safety
Leverage political attention and
commitment to advance accountability.
4
2019-2023 Regulatory Action Plan 4
WHO Action Plan V10.indd 4 01/07/2019 09:31Introduction
5
5 Regulatory Action Plan 2019-2023
WHO Action Plan V10.indd 5 01/07/2019 09:31Foreword Abbreviations Executive Introduction Challenges Strategic An Ambitious Annex A Annex B
Summary & Responses Priorities Agenda
Regulation is sometimes perceived US$3.5 billion worth of urgently • ensuring, through the
as a barrier to access. However, the needed, safe, and effective quality- Prequalification Programme, that
degree to which regulation facilitates assured products accessible to people quality-assured products suitable
the flow of quality goods and services every year, including roughly US$1.5 for public health challenges are
depends on how well it is designed and billion worth of vaccines for routine available for developing markets
implemented. immunization programmes.6,7,8,9 Initially via both donor-funded and pooled-
created to quality-assure vaccines procurement initiatives.
A 2016 study estimated that the overall bought by the United Nations Children's
time required for registration of new, Fund (UNICEF), the prequalification During the 2013–2018 period,
innovative medicines and vaccines in process has since been applied to WHO consolidated the four existing
low- and middle-income countries is medicines, IVDs, certain medical devices prequalification programmes under
typically four to seven years after a and immunization-related equipment, one management and optimised the
marketing authorization dossier has and devices for high-burden diseases in procedures used by each programme. 11
been submitted.1 This compares with LMICs. Through these efforts, WHO
one to two years, on average, in high prequalification now operates much
income countries (HICs).2,3,4,5 Reasons Although WHO is not a regulatory more consistently, and the ‘WHO
for the longer registration times in LMICs authority, its Prequalification Programme time’ required for a prequalification
include bottlenecks caused by multi- has been recognized as a trusted symbol assessment is now comparable to that
stage approval processes, inadequate for safety, quality and efficacy. It has taken by regulators in high-income
funding, and different standards and helped to bring down prices of medicines countries. WHO has also helped NRAs
requirements applied by national and vaccines by providing an avenue for use the tools and procedures of the
regulatory authorities (NRAs), all of LMIC manufacturers to compete in the Prequalification Programme to inform
which impose additional or duplicative donor-funded market. Prequalification their own decision-making. This has
work on manufacturers’ applications. has enabled donors to trust the products enabled much more efficient national
Furthermore, although they are not well that are procured with their funds, and registration of essential medicines and
understood by policy-makers, health- has permitted countries to rely on the has provided another avenue for national
care workers and even by regulators, products coming into their jurisdiction. regulators to build their own national
national requirements for repeated capacities. Based on such successes,
official batch release testing often are a Prequalification has also guided WHO is working with its stakeholders to
major obstacle to market access. innovation and early-stage development build further on the strong foundation
of products that are especially relevant achieved to date.
Medical product regulation is often to LMICs. For example, it played a
thought to be solely concerned with the key role in bringing paediatric TB WHO is uniquely placed to help shape
quality, safety and efficacy of products products to market in Sub-Saharan responses to emerging regulatory
– the so-called guardian role. However, Africa and in the deployment of HIV- challenges at global, regional and
while this role is fundamental, well- 1 viral load IVDs adapted for use national levels. Prominent among these
functioning regulation also enables with dried blood spot specimens.10 challenges is the transition away from
quality-assured products to reach the WHO, in coordination with Member donor-funded procurement towards
people who need them more quickly. The States and key stakeholders, works in more locally funded supply of medical
2016 study cited above, for example, four main areas to support regulators products. To successfully negotiate this
notes that regional collaboration in 2010 worldwide: transition, it will be necessary to support
among NRAs in Sub-Saharan Africa (with country and regional accountability and
technical support from WHO) permitted • establishing and promulgating the ownership of regulation.
rapid approvals of a meningitis vaccine norms and standards on which
in several countries and resulted in a effective product regulation is based WHO’s regulatory work initially focused
huge drop in meningitis cases that has • strengthening the regulatory on activities dealing with norms and
been well documented. systems of Member States, including standards and on the Prequalification
regulatory preparedness for public Programme. While continuing and, in
Of course, product quality is in itself an health emergencies some cases, expanding its work in these
enabler of access. This, in essence, is • implementing and encouraging vitally important product-specific areas,
the point of the WHO Prequalification improved safety monitoring and WHO is sharpening its focus on the
Programme, which makes approximately vigilance regulatory systems of Member States,
helping to build national and regional
2019-2023 Regulatory Action Plan 6
WHO Action Plan V10.indd 6 01/07/2019 09:31capacity and to increase regulatory
effectiveness and efficiency. This will be
done by encouraging greater regulatory What are medical
collaboration, increasing regulatory
efficiency through reliance mechanisms, products?
and applying harmonised standards
that are internationally-recognized and Medical products include
science-based. WHO is also putting
greater emphasis on safety and vigilance medicines, vaccines, in
and on combatting the threat of
substandard and falsified (SF) products. vitro diagnostics, medical
To support these efforts, WHO has devices (including
developed this Plan for the period
2019–2023, designed to generate immunization devices),
greater impact at country level. The Plan
is closely aligned with the WHO 13th cold-chain equipment,
General Programme of Work (GPW13),
which sets out the broad strategic goals vector control products,
for the Organization in the coming five
years and prioritizes three objectives: blood and blood
increased health coverage increased
health emergency response and products, antivenoms,
increased population health.12
monoclonals and other
Ensuring quality, safety and efficacy
is prioritized by WHO as one of two biotherapeutic products.
interlinked strategic areas necessary
to support access to medical
products (the other is innovation).
The Plan is also aligned with WHO’s
“Towards Access 2030” framework,
which makes strengthening regulatory
capacity and practices a primary goal
and the recently concluded access
roadmap.15
While ensuring the quality of medical
products procured at the international,
regional and national levels remains an
overarching principle, the 2019–2023
Plan shifts the focus towards supporting
countries and regions, and towards
promoting regulation informed by the
principles of regulatory collaboration and
reliance.16 Although ambitious, the Plan
is feasible given the appropriate support,
and will enable Member States to tackle
many of the regulatory challenges they
will face in the next five years.
7 Regulatory Action Plan 2019-2023
WHO Action Plan V10.indd 7 01/07/2019 09:31Foreword Abbreviations Executive Introduction Challenges Strategic An Ambitious Annex A Annex B
Summary & Responses Priorities Agenda
References
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Lumpkin M, Hartman D. Speeding access content/uploads/2019/05/CIRS-RD- 11. WHO Prequalification programme:
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middle-income countries: a case for change accessed 06.06.2019) (accompanying figures – publication in
and a framework for optimized product preparation)
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(11):e0166515 Organization Prequalification Programme- 12. A healthier humanity: the WHO
playing an essential role in assuring quality investment case. Geneva: World Health
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Sillo HB A quiet revolution in global public report by the Secretariat. Geneva: World
3. Activities report of the health: The World Health Organization’s Health Organization; 2017 (http://www.
generic drugs program (FY 2018): Prequalification of Medicines Programme J who.int/iris/handle/10665/274799,
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Silver Spring (MD): U.S. Food and Drug 61. doi: 10.1057/jphp.2013.53. Epub 2014
Administration; 2018 (https://www.fda. Jan 16 14. Towards access 2030: WHO
gov/Drugs/ResourcesForYou/Consumers/ essential medicines and health products
BuyingUsingMedicineSafely/GenericDrugs/ 8. Ortega Diego I, Fake A, Stahl M, strategic framework 2016-2030. Geneva:
ucm600678.htm, accessed 12.02.2019) Rägo L. Review of quality deficiencies found World Health Organization; 2017 (http://
in active pharmaceutical ingredient master www.who.int/medicines/ publications/
4. Jawahar. N and Datchayani. B. files submitted to the WHO Prequalification Towards_Access_2030_Final.pdf?ua=1,
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their approval process in US, Europe and Sci. 2014;17(2):169-86. Review
Japan. Journal of Pharmaceutical Sciences 15. Road map for Access to Medicines,
and Research. 2018;Vol.10(3): 523-527 9. External Assessment Report Vaccines and other Health Products, 2019-
(http://jpsr.pharmainfo.in/Documents/ ‘Impact assessment of WHO Prequalification 2023: Comprehensive support for access
Volumes/vol10Issue03/jpsr10031820.pdf , and Systems Supporting Activities’ (in to medicines, vaccines and other health
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ebwha/pdf_files/WHA72/A72_17-en.pdf
5. Rodier C, Bujar M, McAuslane 10. Pannus P, Claus M, Gonzalez MM,
N, Liberti L. R&D Briefing 70: New drug Ford N, Fransen K. Sensitivity and specificity 16. Regulatory collaboration:
approvals in six major authorities 2009- of dried blood spots for HIV-1 viral load collaboration, not competition: developing
2018: Focus on Failicated Regulatory quantification: a laboratory assessment of new reliance models. WHO Drug
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2019-2023 Regulatory Action Plan 8
WHO Action Plan V10.indd 8 01/07/2019 09:31Foreword Abbreviations Executive Introduction Challenges Strategic An Ambitious Annex A Annex B
Summary & Responses Priorities Agenda
Major regulatory
challenges and
responses
WHO/...
9 Regulatory Action Plan 2019-2023
WHO Action Plan V10.indd 9 01/07/2019 09:31Foreword Abbreviations Executive Introduction Challenges Strategic An Ambitious Annex A Annex B
Summary & Responses Priorities Agenda
Major regulatory challenges
and responses
The main regulatory challenges can be broken down into three broad groups. The first is ongoing challenges
such as limited resources, and policies and approaches that hamper many NRAs from working optimally. The
second is emerging issues linked to increasingly complex medical products (e.g. biotherapeutic products),
and rising demand for regulatory responses to conditions arising in health emergencies. The third group of
challenges is related to the speed and span of advancement in technologies and innovation. All groups of
challenges affect national regulatory systems and processes, including crucial measures that support product
safety, vigilance (for all medical products, including pharmacovigilance), and supply chain integrity. On a
broader scale, they threaten countries’ abilities to achieve the Sustainable Development Goals (SDGs), and
place serious obstacles in the way of the drive to reach universal health coverage.
Challenge: Limited capacity to carry out all
core regulatory functions
WHAT IS
Capacity issues facing many NRAs loom large among the
ongoing regulatory challenges facing Member States.
PHARMACOVIGILANCE?
According to WHO surveys based on independent, peer-
reviewed audits, in 2018 only 30% of NRAs had the capacity to Pharmacovigilance is the
effectively and efficiently regulate products on their markets.17 science and activities relating
In general, there was greater capacity to regulate
medicines and vaccines than to regulate other products.18 to the detection, assessment,
understanding and prevention of
Capacity limitations affect a range of basic regulatory adverse effects or any other drug-
functions such as assessment of new products and the
task of managing variations to already approved products.
related problem. Its aims are to
Lack of capacity to assess new and innovative products enhance patient care and patient
slows the journey from laboratory to market of urgently safety in relation to the use of
needed products. A 2016 study revealed that overall time
medicines and to support public
to registration for medicines and vaccines in LMICs typically
takes four to seven years after completion of Phase 3 health programmes by providing
trials and assembly of a marketing authorization dossier, reliable, balanced information for
compared to an average of one to two years in HICs.20 the effective assessment of the
Other important barriers to access arise as a result of risk-benefit profile of medicines.19
poorly designed or maladapted regulation. For example,
multi-stage approval processes can delay products from
achieving widespread availability by several years.21 Moreover,
because regulatory legislation differs from country to
country, manufacturers are too often obliged to navigate
multiple regulatory systems to register the same product
across countries, resulting in increased costs and delays.22
The challenges presented by the increasing complexity and
globalization of trade are exacerbated by lack of coordinated
regulation, even in the same region. There are increasing
numbers of difficult-to-regulate global supply chains, in which
multiple companies may be involved in producing products that
then move through several countries and several distributors
before finally reaching a patient.
2019-2023 Regulatory Action Plan 10
WHO Action Plan V10.indd 10 01/07/2019 09:31Foreword Abbreviations Executive Introduction Challenges Strategic An Ambitious Annex A Annex B
Summary & Responses Priorities Agenda
Response: Build capacity, there is a growing trend for them to on outputs (e.g. scientific assessments,
work together in regulatory networks. inspections, batch release testing, post-
increase collaboration and As stated in the 2018 International marketing safety data) from an advanced
reliance Conference of Drug Regulatory authority while adapting that work to
Authorities (ICDRA) recommendations,24 its own circumstances and retaining
WHO has the knowhow and experience the concept of reliance and increasing its own regulatory decision-making
to help countries strengthen their regulatory collaboration requires both responsibilities.26
regulatory systems. In 2018, for trust and the capacity to share and
example, the United Republic of rely on regulatory work performed by In the coming years, WHO will play
Tanzania’s regulatory authority became trusted NRAs. Regulatory collaboration an important role in supporting the
the first documented NRA in Africa to can take a variety of forms, from transition from donor- to country-based
achieve maturity level 3 (ML3), assessed information or work-sharing to mutual procurement by strengthening regulatory
as having a stable, well-functioning or unilateral recognition of assessment systems for selected LMICs. A strong
and integrated regulatory system and inspection results. voice from WHO will be needed to
according to the indicators of the reduce the risk that individual countries
WHO Global Benchmarking Tool (GBT). Recognition, which is also a form of may promote local production as part
This successful result stemmed from reliance, is defined as “the routine of their national development agenda
the country’s prioritized institutional acceptance of the regulatory decision without parallel efforts to strengthen
development plan, which was itself of another regulator or other trusted regulatory systems – the only way to
guided by the GBT.23 institution. Recognition indicates ensure that products meet international
that evidence of conformity with the standards of quality, safety and efficacy.
However, as LMICs transition from regulatory requirements of country To achieve this, WHO will require robust
internationally funded procurement A is sufficient to meet the regulatory policy tools and a coordinated approach
mechanisms to local procurement of requirements of country B.”25 to country support, working closely
products, there will be increased pressure with other UN agencies and partners
to develop the regulatory capacity However, experience shows that mutual to ensure that medical products are
required to ensure that products are of recognition agreements may take manufactured within effective regulatory
assured quality, safety and efficacy. Since considerable time to set up, and so environments. WHO will also continue
the majority of NRAs worldwide lack the NRAs are increasingly moving towards providing practical hands-on capacity-
resources and capacity to perform all other forms of reliance. In general, building activities at county and regional
regulatory functions well and increasing reliance implies that one NRA relies levels.
number of medical products are
manufactured and distributed globally,
The United Republic of Tanzania’s
Food and Drug Authority, with
the support of WHO, has become
the first documented NRA in
Africa to have achieved a stable,
well-functioning and integrated
regulatory system (ML3).
Dr Tigest Ketsela Mengestu, WHO Representative in the United
Republic of Tanzania, congratulates Ms Ummy Mwalimu, the
country’s Minister of Health, Community Development, Gender,
Elderly and Children.
11 Regulatory Action Plan 2019-2023
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Summary & Responses Priorities Agenda
A PROGRAMME
WITH TEETH
‘The WHO Prequalification
Programme is strict and
does not hesitate to
delist products when the
applicant’s dossiers are
not up to standard. This
happened in 2011 for
vaccines, when WHO
delisted a pentavalent
vaccine, and in 2004 for
medicines, when the WHO
delisted generic ARVs
because of irregularities
at the clinical study sites
where bioequivalence was
established, signalling to the
industry the Prequalification
Programme had teeth.’
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Challenge: Current scope of In 2018, prequalification of medicines Prequalification does not yet cover
focused on treatments for HIV/AIDS, products such as anti-cancer therapies,
the prequalification eligibility anti-diabetics, anti-hypertensives, the
malaria, TB, reproductive health,
list hepatitis, diarrheal diseases, influenza majority of antimicrobials (beyond those
and a selection of neglected tropical used for HIV and tuberculosis), or IVDs
The WHO Prequalification Programme diseases. Prequalification of vaccines for meningitis and non-communicable
is constantly evolving in order to meet ensured evaluation of vaccines that diseases.
the changing health needs of Member are required for routine immunization
States. As of December 2018, WHO against 24 priority diseases, and of the
has prequalified over 1 770 medical
Response: Expand
immunization devices and cold-chain
products, including: equipment needed for an effective prequalification list
national vaccination programme, and
• 663 finished pharmaceutical also performed risk assessment of certain Subject to endorsement by a
products (FPPs) vaccines that might be used in a public consultative process by both public
health emergency. Prequalification and specialized WHO advisory groups,
• 140 active pharmaceutical
of IVDs assessed a wide variety of in eligibility for prequalification assessment
ingredients (APIs)
vitro diagnostics for both endemic will be expanded based on an evaluation
• 88 IVDs and epidemic diseases in LMICs, with of specific needs for products (generic
a focus on high burden diseases such or established) and also innovative
• two male circumcision devices
as HIV/AIDS, malaria and hepatitis products on the Essential Medicines
• 333 vaccines for 24 priority C. Prequalification of vector control List and the Essential Diagnostics List.
diseases products converted past WHO product This expansion should, on the one hand,
• 413 immunization devices and evaluations to prequalification and address priority unmet needs)28 and, on
cold-chain equipment assessed new public health pesticides the other hand, not jeopardize ongoing
in a wide variety of formulations, all of prequalification work or undermine
• 76 vector control products which are intended to reduce the burden the confidence that procurement
including insecticide-treated nets, of vector borne diseases (e.g. malaria, agencies and Member States have in the
and indoor sprays dengue fever, Zika virus diseases, etc.) by Prequalification Programme. It is also
• 53 quality-control laboratories controlling the organisms that transmit important to ensure that the Programme
the diseases to humans. remain nimble and responsive to rapid
shifts that may occur in the types and
quantities of products needed.
WHO/Emro-Aden
13 Regulatory Action Plan 2019-2023
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Summary & Responses Priorities Agenda
Challenge: Gaps in capacity
to respond to public health
emergencies
A matter requiring particular attention In July 2018, WHO used the GBT to
from NRAs in coming years will be to map emergency provisions for clinical
strengthen their contribution to public trial oversight in 40 countries (see Figure
health emergency responses. Recent 1), finding that approximately 70% of
crises have exposed major regulatory countries lack legal provisions to permit
challenges in global preparedness fast-track clinical trial authorizations.
for such emergencies, notably the The same mapping showed that 50%
2014 and current Ebola outbreaks. of countries lacked legal provisions
A particular challenge is to quickly to permit emergency-prone product
evaluate candidate products developed registration procedures, which may
during the emergencies themselves, be required in the interest of public
often based on limited data while the health. Many NRAs also reported to
situation is evolving. Poor engagement WHO that they lacked the capacity or
of some product developers with tools to communicate effectively with
affected country regulators also has stakeholders during crises, particularly
been observed. the media and general public.
Figure 1. Forty countries benchmarked to map
emergency provisions for clinical trial oversight
2019-2023 Regulatory Action Plan 14
WHO Action Plan V10.indd 14 01/07/2019 09:31Foreword Abbreviations Executive Introduction Challenges Strategic An Ambitious Annex A Annex B
Summary & Responses Priorities Agenda
Response: Develop expedited Challenge: A flood of Response: Invest in
regulatory processes substandard and falsified prevention, detection, and
medical products response
WHO’s Emergency Use Assessment and
Listing (EUAL) procedure was developed Weak regulatory systems create Effective responses to SF products are
in 2015 to expedite the availability of opportunities for the manufacturers founded on preventing the conditions that
medicines, vaccines and IVDs needed in and purveyors of substandard and permit their manufacture, distribution
public health emergencies. falsified (SF) products. Broadly speaking, and consumption. Regulatory system
substandard products reach patients strengthening and oversight has a key
An informal WHO consultation when tools and technical capacity are part to play in this. It is also critical that
regarding regulatory preparedness inadequate to enforce quality standards Member States develop the capacity to
for health emergencies, held at WHO in manufacturing and the supply chain. detect SF products quickly and share
headquarters in May 2017, produced The circulation of falsified products is a the information via the GSMS. It is also
a number of recommendations to criminal activity facilitated by corruption vital to halt production and distribution,
guide the development of expedited and unethical practices involving recall products and punish offenders.
regulatory procedures for previously wholesalers, distributors, retailers and WHO focuses its efforts in prevention
unlicensed medical products during health workers. detection and response, working within
public health emergencies. The meeting the Member States Mechanism (MSM)
also recommended that the process According to a 2017 WHO report, which was established at the request of
be renamed Emergency Use Listing one in ten medicines in LMICs is
(EUL), that the procedure include the World Health Assembly in 2012.35
substandard or falsified, while an
risk management, surveillance, and estimated $30 billion is wasted on
communication provisions, and that such medicines in LMICs every year.32 Challenge: Underreporting
a preparatory process (‘pre-EUL’) be All therapeutic classes are concerned,
explored to improve preparedness. A of adverse reactions to
but most SF medical product reports
roadmap was subsequently developed entered into WHO’s Global Surveillance medicines, and poor post-
to put these recommendations into and Monitoring System (GSMS) in marketing monitoring by
practice and to develop processes in
receiving countries to authorize the
2018 related to antimalarials (19.5% of authorities
total reports) and antibiotics (16.9%).33
use of products listed by WHO.29, 30 Both generic and innovator products, The underreporting of adverse drug
expensive and inexpensive, are affected, reactions (ADRs), adverse events
For their part, regulators must ensure and SF versions are found in both
that their emergency review processes following immunization (AEFI), and
public and private supply chains.34 adverse events related to use of
are robust, effective and responsive. Promotion and distribution of SF medical devices (AEMD) including
products through the Internet is a IVDs, continues to be a core concern,
Regulatory networks are a key major concern both in high-income
element of strengthening regulatory particularly in LMICs. This is borne
countries and, increasingly, in middle- out by the roughly 16 million VigiBase
preparedness. This was demonstrated income countries. The increasing
by the performance of the African reports accumulated over nearly 50
globalisation of the medical products years, only 12.5% of which come from
Vaccine Regulatory Forum (AVAREF) market is also greatly complicating the
during the 2014 Ebola crisis31 task of regulators, not least because of LMICs.36
and reconfirmed in a November 2017 jurisdictional complexities when multiple
‘table top exercise’ undertaken with countries are involved.
stakeholders. WHO has subsequently
published a roadmap to coordinate
actions and contributions to the
licensing and roll out of Ebola vaccine in
African countries.30
15 Regulatory Action Plan 2019-2023
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Summary & Responses Priorities Agenda
The main reason for underreporting is the While access to essential, priority
lack of resources to establish functional medicines has improved over the years,
pharmacovigilance systems. Another pharmacovigilance systems haven’t kept
ongoing challenge is the low priority up or improved proportionately. New
given to ADR/AEFI/AEMD reporting by products such as bedaquiline (to treat
policy makers and decision takers, who multi-drug-resistant tuberculosis) and
may not recognize its importance to their dolutegravir (a new-generation HIV
population’s health. The introduction of medication), have been introduced into
products, including malaria vaccines and countries with little or no capacity to
tuberculosis treatments, launched either monitor their safety, underscoring the
exclusively in LMICs or simultaneously fact that a robust pharmacovigilance
in low and high-income countries, is system is needed to safely access and
putting increased pressure on NRAs to use such products effectively.
meet their obligations and highlights
the need for more proactive post- Pharmacovigilance has an important
marketing monitoring. Another growing role to play, offering unique insights
challenge is the spread of false safety into the real world of interactions
concerns regarding vaccines via the between people and the medical
Internet and social media. These have products on which they rely. However,
reduced coverage due to mistrust of it is vital that health authorities make
vaccines and have led to outbreaks of use of the information that is being
vaccine-preventable disease, such as gathered. Risk-based prioritization of
measles in Europe and the Americas.37 pharmacovigilance efforts that consider
smarter and more proactive approaches
Response: Improve monitoring should be explored. Opportunities to
consider such approaches are therefore
and reporting on adverse being pursued. One example is, Project
events and safety issues, and 3-S, a partnership between WHO and
ensure health authorities the Bill & Melinda Gates Foundation
that aims to integrate ‘Smart Safety
make use of results Surveillance’ for priority medical products
in four to six countries at different
Improving the reporting of ADRs, AEFIs levels of pharmacovigilance readiness.38
and AEMDs requires greater investment
in the systems established for this
purpose, notably the Programme for
International Drug Monitoring (PIDM),
the VigiBase electronic database, and the
Global Vaccine Safety Initiative (GVSI).
Investment is also required to strengthen
National Pharmacovigilance Centres.
Currently 164 Member States have a
recognized National Pharmacovigilance
Centre and participate in the WHO
PIDM. Of these countries, 130
contribute reports, of varying degrees
of quality and quantity, to the WHO
VigiBase. However, very few of these
countries use or act on their national
data. It is important that more countries
collect good-quality pharmacovigilance
data, but equally that these countries
receive support in order to use the data
that they collect.
WHO
2019-2023 Regulatory Action Plan 16
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Summary & Responses Priorities Agenda
References
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2018 (WHO/EMP/2018.01). Licence: CC BY-NC- Regulatory Authorities. WHO Drug Informa- (AVAREF): A platform for collaboration in a public
SA 3.0 IGO. Available at http://apps.who.int/iris/ tion Vol. 32, No. 4, 2018 https://www.who.int/ health emergency. WHO Drug Information Vol.
handle/10665/272972 medicines/publications/druginformation/issues/ 29, No. 2, 2015, 127-131
WHO_DI_32-4_18ICDRA.pdf?ua=1 (Accessed:
18. Belgharbi L, Khadem Broojerdi A, 20 March 2019) 32. A study on the public Health and socio-
Rodriguez-Hernandez C and Wood DJ (2016) economic impact of substandard and falsified
Regulation of vaccines in low and middle-income 25. WHO. ‘WHO Global Benchmarking medical products. Geneva: World Health Organ-
countries. Vaccines, 7th Edition, Eds. Plotkin SA, Tool (GBT) for Evaluation of National Regulatory ization; 2017. https://www.who.int/medicines/
Orenstein WA, Offit PA, Elsevier Saunders System of Medical Products. Glossary and Defi- regulation/ssffc/definitions/en/
nitions Revision (VI Version)’, 1 November 2018.
19. www.who.int/medicines/areas/quality_ https://www.who.int/medicines/regulation/10_ 33. ‘A study on the public health and so-
safety/safety_efficacy/pharmvigi/en/ GBT_Glossary_RevVI.pdf?ua=1 cioeconomic impact of substandard and falsified
medical products’. Geneva: World Health Organ-
20. Ahonkhai V, Martins SF, Portet A, 26. WHO Drug Information, Vol 30, No4, ization; 2017. https://www.who.int/medicines/
Lumpkin M, Hartman D. Speeding access to vac- 2016. Collaboration, not competition: develop- regulation/ssffc/publications/se-study-sf/en/
cines and medicines in low- and middle-income ing new reliance models. http://www.who.int/
countries: a case for change and a framework medicines/publications/druginformation/WHO- 34. WHO Global Surveillance and Mon-
for optimized product market authorization. DI_30-4_RegCollaboration.pdf itoring System for SF Products. https://www.
PloS One. 2016;11 (11):e0166515 (https://doi. who.int/medicines/regulation/ssffc/publications/
org/10.1371/journal.pone.0166515, accessed 27. Rägo, L., Sillo, H., ’t Hoen, E. & GSMS_Report_layout.pdf?ua=1
12.02.2019) Zweygarth, M. Regulatory framework for access
to safe, effective quality medicines. Antivir. Ther. 35. Substandard/spurious/falsely-labelled/
21. Achieving a bold vision for global 19 Suppl 3, 69–77 (2014). falsified/counterfeit medical products. (with an-
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R&D. Washington, DC: Global Health Technolo- 28. Aragon, Chalkley, and Goddard, Maria spurious/falsely-labelled/ falsified/counterfeit
gies Coalition; 2016 Available at www.ghtcoali- Karen (2017) Defining and measuring unmet medical products. Goal, objectives and terms
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for neglected diseases. Clinical Trials, vol. 7, 6: pp. 29. WHO Informal Consultation on Uppsala: Uppsala Monitoring Centre; 2017 www.
719-734., First Published November 25, 2010. options to improve regulatory preparedness to who-umc.org
https://doi.org/10.1177/1740774510386390 address public health emergencies,17-19 May
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23. Tanzania is first African country to Organization; 2017. Available from www.who.int due to gaps in vaccination coverage. https://www.
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WHO/... Summary & Responses Priorities Agenda
Strategic
priorities and
goals
WHO/Shutterstock
2019-2023 Regulatory Action Plan 18
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Summary & Responses Priorities Agenda
Strategic priorities and goals
Based on an analysis of the challenges An essential support in the The concept of reliance is described as
faced and a careful assessment of where follows:39
WHO can most add value in supporting
drive towards UHC
regulators, four strategic priorities have In general, reliance implies
been identified for the current Plan. Effective and efficient regulation of
medical products is crucial both to global that the work done is shared
Aligned with GPW13 and supporting
the global drive towards universal health health and to achieving sustainable by the advanced authority
coverage, these strategic priorities are development. In fact, the two are (e.g. through assessment or
informed by the dual imperatives of indivisible. Sustainable Development inspection reports), while the
Goal 3.8 specifically describes “access
assuring the quality of medical products receiving authority uses this
and supporting optimal access. The to safe, effective, quality and affordable
essential medicines and vaccines for all’” work according to its own
strategic priorities are as follows:
as central to UHC. Similarly, Sustainable scientific knowledge and
Development Goal 3.b underscores the regulatory procedures and
strengthen country and regional pressing need for new medicines to be retains its own regulatory
regulatory systems developed if persistent treatment gaps
responsibilities. For example,
are to be solved.
improve regulatory preparedness when an assessment report for
for public health emergencies The current context is marked by a medicine authorized in the
reinforce and expand WHO
increasing demand for greater product EU is shared with a regulatory
prequalification and product risk
access, often in the context of health authority in Africa, the
systems striving towards UHC. This
assessment receiving authority might still
demand will bring with it a range of
increase the impact of WHO regulatory pressures that will be difficult need to consider differences
regulatory support activities. for many resource-constrained countries in conditions of use, patient
to meet. population and other
parameters. In many cases
Activities to achieve these priorities will Key principles: collaboration reliance on the assessment
be guided by carefully defined goals and
objectives (Annex A). Specific activities and reliance or inspection work carried
will be further detailed in annual activity out by another advanced
plans and Key Performance Indicators The manufacture and distribution of regulatory authority can be
(KPIs) will be developed to monitor modern medical products is increasingly the best way to cooperate
progress. This chapter presents an globalized. For this reason, cooperation
effectively. Reliance can be
overview of the main goals and their between national and regional regulators
implications for the work of WHO. In has become essential, and a variety of unilateral, bilateral (mutual) or
many cases WHO is already working in types of collaboration are being applied multilateral.
the relevant areas. In others, achieving in different parts of the world. A key
the goals and objectives identified will approach to collaboration is reliance, a It is important to note that trust-building
require new activities and adopting means of sharing knowledge and best between Member States, both at the
different approaches. practices while avoiding duplication of level of the regulatory authorities but
work. equally at the political and societal level,
is important in building reliance among
various stakeholders, including patient
groups, regulatory initiatives, industry,
and more. WHO is currently developing
guidance on good reliance practices.
19 Regulatory Action Plan 2019-2023
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