Transcript WHO Assessment of National Medicines Regulatory Systems WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies WHO Headquaters, Geneva (Switzerland) 29 October - 2 November 2012 Alain.

WHO Assessment of National
Medicines Regulatory Systems
WHO/UNICEF Technical Briefing Seminar on Essential
Medicines Policies
WHO Headquaters, Geneva (Switzerland)
29 October - 2 November 2012
Alain PRAT, Technical adviser, QSM/EMP/HSS
Objectives of the presentation
 Provide the answers to the following questions:
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What it is an assessment?
Why an assessment tool?
How it works?
What we achieved and where we want to go?
 Provide some references
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Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva
Definitions: Medicines Regulatory Authority
(MRA)
 An entity/organization/structure in charge of the
administration of the medicines regulation, including at
least one of the following regulatory activities:
– Issuing marketing authorization of new products and dealing with variation
of existing products;
– Testing the Quality of products;
– Monitoring adverse drug reaction and events;
– Inspecting and licensing of manufacturers, wholesalers and distribution
channels and related enforcement operations;
– Controlling medicines promotion and advertisement
– Providing of medicines information and promotion of rational use of
medicines;
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Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva
Definitions: National Medicines Regulatory
System (NMRS)
 The institutional arrangements of the national and/or
regional and/or local bodies in charge of implementing and
supervising the medicines regulation
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Department in the Ministry of Health;
Specialized Agency;
Regional authority
Pharmacy Board;
Quality control laboratories;
Pharmaceutical council
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Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva
Definitions (suite)
 Assessment
– the systematic and objective evaluation of the relevance,
adequacy, efficiency, effectiveness and impact of a course of
actions, in relation to the implementation of medicines regulation,
taking into account the resources and facilities that have been
deployed, the people, institutions and resources, arranged
together in accordance with established policies, for the purpose
of improving regulatory performances
 Assessment tool
– the instruments used to gather data. It can be both quantitative
and qualitative, and refer to both traditional review of
documentation, as well as to alternative forms of assessment such
as questioning staff, direct observations, and others.
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Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva
Why an assessment tool ?
 To provide for evidence
– on the current situation regarding the medicines regulation and its
implementation by identifying strengths and weaknesses
 To make recommendations on identified gaps for
improvement
 To use assessment results as a tool for convincing
decision-makers to gain support
In line with one of the MRS strategic objectives
– To strengthen National Medicines Regulatory Authorities
(NMRAs) capacities
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Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva
Main steps of the assesssment / 1
 Expression of a need
– Internal / External
– Scope of the assessment
– Objectives and expected outcomes
 Assessment team
– Qualification, experience, availability
– Minimun 2
– Staff from the organization assessed
 Preparation works
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Request baseline information
Study of available information
Validation of the scope covered
Preparation of the assessment plan
Validation of the plan with the institution
Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva
Main steps of the assessment / 2
 Opening session
– Presentation of assessment team, objectives, methodology
– Presentation of the authority
 Conducting the visit
– Follow planned activities,
– Collection of evidence
 Closing session
– Presentation of the main findings and related recommendations
– Presentation of the institutional plan
– Closing remarks
 Follow up
– Provide for the draft report, collect the comments and finalize
– Initiate/consider supportive actions
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Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva
Comprehensive scope of the tool
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Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva
Design of the assessment tool
 Same format for each modules / functions
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Legal basis, framework
Guideline and Documentation
Organisation and structure
Planning and internal procedures
Human and other Ressources
Records and others outputs
Availability of these information
Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva
Assessment strategy
Top
Legislation / Act
Decret / Regulation
Guidelines
Operating procedures
Templates
Decisions
Records
Regulatory pyramide
Down
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Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva
Assessment methodology
 Not based on impressions, feelings or any subjective
considerations
 Based on objective evidence of the existence, the
implementation and the results
 Evidence collected through interviews should, whenever
possible, be confirmed by more objective means
 Possible deficiencies or gaps should be thoroughly
investigated and validated
 Consensus should be reached at the end with auditees
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Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva
Review of the regulatory system
NMRA A
S
T
E
W
A
R
S
H
I
P
Regulatory function 1
NMRA B
Regulatory function 2
Regulatory function 3
Regulatory function 4b
NMRA C
Regulatory function 4b
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Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva
Assessment of the institution(s)
 Legal basis
 Leadership & Governance
 Organizational structure in place
 Quality & Risk management system
 Management of finances (Fees)
 Management of human resources
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Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva
Assessment of the institution(s)
 Independence and impartiality
 Transparency and confidentiality
 Management of committees and external expertise
 Management of infrastructure and equipment
 Knowledge and IT Management
 Monitoring and accountability
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Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva
Review of the regulatory processes in place
Management Processes
Strategy
Governance
Planification
Accountability
Provision of Regulatory Services
Licensing of manufacturers, importers and distributers
Authorizing the marketing of pharmaceutical products
Performing regulatory inspection and enforcement activities
Performing quality control testing on products
Monitoring adverse drug reactions
Support Processes
Quality
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Human Ress.
Information Tech.
Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva
Finance
Communication
Assessment of the regulatory processes
Equipments and
facilities maintained
Qualified personal
Pertinent guidelines
SOP implemented
Adequate legal
framework
Records
Steps in the marketing authorization process
A
p
p
Reception
Evaluation
Inspection
Tests
Planning
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Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva
Committee
Decision
A
U
T
Provision of an assessment report
 Describing the existing situation
 Providing recommendations in coherence with the
environment (legal framework, political commitment,
availability of resources,..) such as :
– To change laws or decrees
– To develop guidelines
– To reorganise and reshape the structure
(centralized/decentralized activities)
– To implement QMS, to develop procedures and records
– To manage and planning for Human resources
– To implement new approach or strategy
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Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva
Assessment follow up
 Contradictory procedure
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Calling for comments from the institution assessed
Final validation
 Plan of corrective actions developed in collaboration
with WHO country office
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Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva
NMRA assessments worldwide
 62 Assessments performed on 55 Regulatory systems (with
the involvement of who Headquaters)
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AFRO - 28 COUNTRIES / 32 ASSESSMENTS
EURO - 5 COUNTRIES / 5 ASSESSMENTS
EMRO - 8 COUNTRIES / 9 ASSESSMENTS
SEARO - 5 COUNTRIES / 6 ASSESSMENTS
WPRO - 7 COUNTRIES / 8 ASSESSMENTS
PAHO - 2 COUNTRIES / 2 ASSESSMENTS
 WHO Regional assessments (without involving WHO Headquaters)
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 Self-assessments
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Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva
NMRA assessments in AFRO region
2012
2006
2011
2004
2010
2003
2009
2002
2008
2001
2007
Non
2006
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Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva
Findings: Main Act
 Publication of the main law on Medicines
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7
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5
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1
0
Before 1979-1988 1989-1998 1999-2003 2004-2008
1979
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Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva
Findings: Regulatory actors
Marketing
authorization
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A
A
A
A
A
A
A
Licencing
B
A
B
A
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A
B
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Inspection
C
B
C
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B
A
A
A
Quality Control
D
C
D
B
C
B
A
A
Pharm.Vigilance
E
D
A
C
A
A
A
A
Nb of NMRA
5
4
4
3
3
2
2
1
Number of
countries
1
2
2
4
1
6
2
3
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Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva
Findings: NMRA processes
Control Drug
Promotion
Quality Control
Product
Information
Marketing
authorization
Inspection
Pharmaco
vigilance
Import
Control
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Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva
Licensing
Findings : Advisory committees
 Committees involved in the marketing authorization
processes in the AFRO region
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Committee in place
Committee not functional
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4
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Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva
No committee
Findings: GMP
 GMP requirements in the AFRO region
Not required (42%)
Not in line with WHO (24%)
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Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva
Not published (29%)
In line with WHO (5%)
Future improvements
 Improve the tool itself
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Improve the technical content for better scrutiny in particular on
measurement and performance aspects
Improve the usability min managing a number of indicateors
mainly using IT system
Build new features
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to enable comparison of assessments outcomes conducted during a
period of time on the same NMRA
to enable comparison of assessments outcomes conducted on several
NMRAs within the same Regional Economic Community (REC)
Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva
Future improvements
 Improve the process
– Implement Quality management system to cover the
Assessment process
– Implement certification of Assessors within and without WHO
to ensure the same qualification / competence of all assessors
 Update and develop the references we are using
– Revised WHO Guidelines on medicines regulatory systems
 Make converge the various tools used in WHO such
as medicines, vaccines, medical devices, others…
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Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva
Future improvements
 Improve our integration within
Health
Workforce
the HSS concept:
The 6 Building Blocks
Service
Delivery
Health
Information
NMRAs
Leadership
&
Governance
Health
Financing
Health
Products
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Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva
References on Medicines Regulation

Effective Drug Regulation: What can countries do ?
(WHO/HTP/EDM/MAC(11)/99.6)
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How to Develop and Implement a National Drug Policy (Second Edition) (WHO;
2001; 96 pages)
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Effective drug regulation - A multicountry study (WHO; 2002; 47 pages)
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WHO Policy Perspectives on Medicines N°7 - Effective medicines regulation:
ensuring safety, efficacy and quality (November 2003, WHO Geneva)
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Regulation of Pharmaceuticals in Developing Countries: Legal Issues and
Approaches Jayasuriya D.C. (WHO; 1985; 118 pages)
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National drug regulatory legislation: Guiding principles for small drug regulatory
authorities - Annex 8 in WHO Expert Committee on specifications for
pharmaceutical preparation. 35 Report, WHO, 1999 (WHO Technical Report
Series, N°885)
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Assessment of medicines regulatory systems in sub-Saharan African countries:
An overview of findings from 26 assessment reports (2010, WHO Geneva)
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Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva
Thanks for your attention
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Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva