Transcript WHO Assessment of National Medicines Regulatory Authorities (NMRAs) WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies WHO Headquaters, Geneva, Switzerland 31 October - 4 November 2011 Alain.

WHO Assessment of National
Medicines Regulatory Authorities
(NMRAs)
WHO/UNICEF Technical Briefing Seminar on Essential
Medicines Policies
WHO Headquaters, Geneva, Switzerland
31 October - 4 November 2011
Alain PRAT, Technical adviser, QSM/EMP/HSS
Content of the presentation
 Assessment tool and process
 Figures and findings
 Future perspectives
 References
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Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva
Why an assessment tool ?
In line with one of the strategic objectives
– To strengthen National Medicines Regulatory Authorities (NMRAs)
capacities
 To provide for evidence
– on the situation by identifying strengths and weaknesses
– on the improvement by comparison
 To make recommendations on identified gaps for improvement
 To use assessment results as a tool for convincing decisionmakers to gain support
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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
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
Comprehensive scope of the tool
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Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva
150
100
valeur relative
Level of scrutiny - Granulometry
Pulse Wave Modulation
50
0
-50
-100
temps
-150
Limited number of indicators
Example : There is or there is not a guideline on…
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Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva
150
100
valeur relative
Level of scrutiny - Granulometry
Pulse Wave Modulation
50
0
-50
Ad
Qu Sa
Ef
Sp
-100
A
temps
-150
Increased number of indicators on the same subject
Example : In this guideline, there is or not the following aspects:
Administrative part, Quality part, Safety part, Efficacy part, Product
Information
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Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva
150
100
valeur relative
Level of scrutiny - Granulometry
Pulse Wave Modulation
50
0
Qd
-50
-100
Qv
Qs
Qi
temps
-150
Comprehensive number of indicators
Example : In this quality part of this guideline, there is or not the
following aspects:
Impurities, Stability testing for drug substance and drug product,
Validation of analytical method, Pharmaceutical development,
Specifications for drug substance and drug product, …
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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
Assessment of the institution(s)
 Legal basis
 Governance structure
 Organization in place
 Quality management system
 Funding
 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
 Infrastructure and equipment
 Monitoring and accountability
 IT Management
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Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva
Assessment of the NMRA processes
Processes management
Strategy
Governance
Planification
Accountability
Processes Service Provision
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
Processes Support
Quality
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Human Ress.
Information Tech.
Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva
Finance
Communication
Assessment of the NMRA 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
 Describe the existing situation
 Identify the gaps
 Provision of recommendations 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
NMRA assessments worldwide
 54 Assessments performed on 49 Regulatory systems (with
the involvement of who Headquaters)
–
–
–
–
–
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AFRO - 26 COUNTRIES / 30 ASSESSMENTS
EURO - 3 COUNTRIES / 3 ASSESSMENTS
EMRO - 6 COUNTRIES / 7 ASSESSMENTS
SEARO - 5 COUNTRIES / 5 ASSESSMENTS
WPRO - 7 COUNTRIES / 7 ASSESSMENTS
PAHO - 2 COUNTRIES / 2 ASSESSMENTS
 WHO Regional assessments (without involving WHO Headquaters)
– ????
 Self-assessments
– ???
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Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva
NMRA assessments in AFRO region
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
8
7
6
5
4
3
2
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
A
A
A
A
A
A
A
A
Licencing
B
A
B
A
A
A
B
A
Inspection
C
B
C
A
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
6
Committee in place
Committee not functional
11
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
–
–
–
–
Improve the technical content / scrutiny
Improve the usability mainly using IT system
Improve the assessment of the performance of the processes
Build comparative features
•
to enable comparison of assessments outcomes conducted during a
period of time on the same NMRA
– Build regional features
• to enable comparison of assessments outcomes conducted on several
NMRAs within the same REC
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Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva
Future improvements
 Improve the assessment 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
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Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva
Future improvements
 Improve our integration within
Health
Workforce
the HSS six 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)

How to Develop and Implement a National Drug Policy (Second Edition) (WHO;
2001; 96 pages)

Effective drug regulation - A multicountry study (WHO; 2002; 47 pages)

WHO Policy Perspectives on Medicines N°7 - Effective medicines regulation:
ensuring safety, efficacy and quality (November 2003, WHO Geneva)

Regulation of Pharmaceuticals in Developing Countries: Legal Issues and
Approaches Jayasuriya D.C. (WHO; 1985; 118 pages)

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)

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