Transcript Key elements of success - World Health Organization

Regulation of medicines and other health
technologies.
The future of regulation, where are we going?
EMP TBS
November 2014, Geneva
Dr Lembit Rägo
Head,
Regulation of Medicines and other Health
Technologies,
Essential Medicines and Health Products
World Health Organization
E-mail: [email protected]
Content
 What type of health products and what type of
regulation?
 Where are we now?
 Regulatory convergence, harmonization and
collaboration
 Key elements for success
 Concluding remarks
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Where are we now?
 Majority of WHO Member States either medium, small or very small
countries
 Most regulators do not have the resources – both human and
financial - to manage existing, or rather ever increasing obligations
and expectations
 No one "ball game" for "big fish" and "small fish" – in fact, it seems
the capacity gap between "big fish" and "small fish" is increasing
 Big one can take care of themselves, but how to get the rest moving
in order to save lives?
 How with existing/anticipated resources secure patients in
increasingly complex world?
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Who sets the standards? Are standards harmonized?
 New innovative medicines
– International Conference on Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human Use (ICH)
 Multisource (generic) medicines
– WHO has complete set of regulatory guidance starting from GMP and ending
with bioequivalence/biowaiver guidance
 Other types of medicines
– Vaccines, blood products, cell therapies, "biosimilars" - biologicals
– Traditional and complimentary medicines …
 Medical devices including in vitro diagnostics (IVDs)
 Combination products – device plus medicine etc.
 For many product types and issues, no one single set of standards –
regulatory convergence and harmonization
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International Conferences of Drug Regulatory
Authorities (ICDRA)
 Biennial Global meetings bringing together regulators
from around 100 nations
 Promoting information and best practices exchange,
cooperation, harmonization and convergence
 Several initiatives started in ICDRA environment
– ICH initial discussions
– AMRH initiative initial discussions
– Reports from various convergence and harmonization
initiatives
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New: Harmonization of pharmacopoeias
 Pharmacopoeias – need for more change …
 Pharmacopoeial Discussion Group (PDG)
– ICH parties - US, Japanese and European Pharmacopoeia
– WHO observer
 Harmonization beyond PDG – WHO took initiative convening all
functioning pharmacopoeias for further convergence and
harmonization:
 The 1st International Meeting of World Pharmacopoeias, 29
February – 2 March, 2012, Geneva; Switzerland
 The 2nd International Meeting of World Pharmacopoeias, 18-19
April 2013, New Delhi, India … 2014 meetings
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Harmonization of regulatory requirements is
important
• Objective of drug regulation: TO IMPROVE AND
PROMOTE PUBLIC HEALTH
• Harmonization aimed to diminish duplicative efforts,
creates "common language", can facilitate cooperation
and access to medicines
• In case of harmonization of regulations the main
objective should be:
– MEASURABLE PUBLIC HEALTH GAINS
• There may be other gains, but these should be in the
centre
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How to achieve harmonization?
 What are the “lessons learned” from examples of
well-harmonized regulation?
 What are the key elements of success?
 How can these lessons be applied to biomedical
research and medical product development?
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Harmonization initiatives
 Inter-regional, regional and sub-regional – ICH, APEC, Pan
American Network for Drug Regulatory Harmonization
(PANDRH), ASEAN, SADC, EAC (part of AMRHI), Gulf
Cooperation Council etc.
 Not harmonized! – Good Harmonization Practice (GHP)
needed?
– Different organization – with or without strong secretariat
– Different involvement of industries and other parties
– Different in terms of implementation – some focused on
implementation, others rather focused on convergence of
regulatory thinking
– Different focus technical areas/products
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– …
Key elements of success for regulation (1)
 Enabling environment and foundation
– Good Governance principles implemented
– Modern legal systems allowing certain flexibilities
 Political will and shared common vision
 Similar socioeconomic development of participating
countries
 Participants functional regulatory authorities with
necessary capacity and resources available
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Key elements of success (2)
 Willingness to invest into harmonization
 Effective governance and secretariat
 Willingness to cooperate and compromise
 Commitment for implementation and updating/revision
 Commitment for applying Good Regulatory Practice
principles when implementing
…
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Timely access to better (hopefully) medicines ladder
Good Decision Making
Practices
Good Regulatory Practices based on CTD,
alignment and effective cooperation and
worksharing
Harmonization and convergence of technical
requirements in conjunction with harmonized training
principles and model core curricula for regulators
Applicable modern laws and enabling legal system
General Good Governance in Public Sector, including transparency and
accountability
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Other experiences of success
 EU experiences – few regulators from 28 MS take the
active lead but all benefit (harmonization major enabling
factor)
 Joint reviews of clinical trial applications/products across
borders
– AVAREF
– Medicines Prequalification Programme jointly with EAC regulators
– IGDRP – plans joint reviews as well
 Promoting international convergence, harmonized
standards and good review practices by staff exchange
– Medicines prequalification has a 3 months rotational fellow position
for quality assessors
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Concluding remarks (1)
 WHO has promoted regulatory collaboration,
convergence and harmonization long time and will
continue to do so being open to new ideas
 Making medicines is not any more a "local" business and
the era of only locally operating regulators starts to end
 The future of medicines regulation is more in
collaboration and networking; regulators starting to
function more as a functional network rather than
individual players, and individual players focusing on
what they can give the best added value
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16th ICDRA in 2014
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Concluding remarks (2)
14th ICDRA recommendations in 2010 for Medicines
Regulatory Authorities:
 Take account of one another’s work with a view to
improving the efficiency of the global regulatory system.
 Commit resources to form cooperative networks based on
uniformity of standards and inspection systems.
 Engage with regional and international initiatives promoting
harmonization, information sharing and use of data
generated by other regulators as a tool for improving timely
access to medicines and medical products.
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Concluding remarks (3)
 It is clear that NOT ALL national regulators can fulfill
themselves ALL the functions and decisions have to be
made nationally on which areas to focus and build
capacity, and in which areas rely on other regulators work
 Harmonization alone cannot help, but can form a solid
basis for the new regulatory paradigm to evolve in the
future –
 Doing locally what nobody is doing/can do for you,
(added value) and decide in which area you invest to
specialize to be a "world class player" in the
Regional/Global Network
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