who, geneva, switzerland 18 november 2009
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WHO, Geneva, Switzerland 18 november 2009. Alain PRAT, Technical adviser, MRS/TCM/HSS WHO - Geneva. Assessment of Medicines Regulatory Authorities (MRAs). Plan of the session. The assessment process The process approach The content of the assessment tool Some figures and outcomes. - PowerPoint PPT PresentationTRANSCRIPT
WHO, Geneva, Switzerland18 november 2009
Alain PRAT, Technical adviser, MRS/TCM/HSS
WHO - Geneva
Assessment of Medicines Regulatory Authorities (MRAs)
Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva2 |
Plan of the sessionPlan of the session
The assessment process
The process approach
The content of the assessment tool
Some figures and outcomes
Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva3 |
Why an assessment tool ?Why an assessment tool ?
In line with one of the strategic objectives – To strengthen National Regulatory Authority's capacities
To assess in order to to identify strengths and weaknesses
To make recommendations on identified gaps for improvement
To propose/suggest supporting activities to satisfy the identified needs
To use assessment results as a tool for convincing decision-makers to obtain more support;
Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva4 |
Main steps of the assesssment / 1Main 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 – 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, MRS/TCM/HSS WHO/HQ Geneva5 |
Main steps of the assessment / 2Main 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
Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva6 |
Mapping the regulatory actorsMapping the regulatory actors
Regulatory functions Related actors / Institutions
Manufacturers, distribution channel licensing
MoH
Registration NRA
Regulatory Inspections Inspectorate
Quality control laboratory NQCL
Safety monitoring of marketed products
National Vigilance center
Clinical trial Institutional Review Boards
Control of drug promotion Drug Information Center
Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva7 |
Mapping the processes / Historical findings based on 21 assessmentsMapping the processes / Historical findings based on 21 assessments
Marketing authorization
Licencing
Regulatory Inspection
Quality Control
Pharm.Vigilance
Number of MRA = 21
1 2 2 4 1 6 2 3
Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva8 |
Assessment methodologyAssessment methodology
Not based on impressions, feelings or any subjective considerations
Based on objective evidence
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
Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva9 |
Documented evidenceDocumented evidence
Interviewing personnel
Reviewing manuals, guidelines developped
Studying records
Reading reports
Scanning files or applications
Analyzing data, indicators
Observing activities performed and facilities where they are performed
Examining conditions during these activities
Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva10 |
Documented evidenceDocumented evidence
Investigations not only to check the presence or the absence of a document (law)
But to pursue to find the evidence on the implementation
And ideally the evidence that it provides the desire results…..
Examples : – Law has been issued and Regulation is missing– Law and regulation are published but no guidance is provided to
applicants– Administratives procedures are established but no records are
demonstrating its implementation– Administratives decisions are published but without any legal
framework
Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva11 |
Mapping the processes / 1Mapping the processes / 1
Ressources are input for the process– Results are the outputs of the process
Outputs from the process N – are inputs for the process N+1
Outcomes are very often difficult to assess
ProcessesStructures/
InputsOutputs
Outcomes
Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva12 |
Mapping the processes / 2Mapping the processes / 2
Manage vision, mission, strategies, policies
Manage the ressources needed : human and others
Manage the relation with patient and customers
Manage the production of products and/or services
Manage supporting activities
Manage continuous improvement
Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva13 |
MRA is a process in itselfMRA is a process in itself
Marketing authorization
Regulatory Inspection
Product Information
Pharmacovigilance
Import Control
Licensing
Control Drug Promotion
Quality Control
Few business processes
Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva14 |
Recent improvement for the toolRecent improvement for the tool
Chapter on clinical trial developed
Chapter on vigilance aspects developed
New chapter on Narcotics
New chapter on International cooperation
Quality management system for NRAs
No more open question
All chapters reviewed and design consolidated
Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva15 |
Design of the assessment toolDesign of the assessment tool
Same format for each modules / functions– 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, MRS/TCM/HSS WHO/HQ Geneva16 |
Chapters of the toolChapters of the tool
Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva17 |
Institutional structure / 1Institutional structure / 1
Legal basis
Governance structure
Organization in place
Quality management system
Funding
Management of human resources
Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva18 |
Institutional structure / 2Institutional structure / 2
Independence and impartiality
Transparency and confidentiality
Management of committees and external expertise
Infrastructure and equipment
Monitoring and accountability
IT Management
Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva19 |
Application DecisionMA + Ann.
Marketing Authorization
Qualified personal
SOP implemented
Assessment process
Adequate legal framework
Equipments and facilities maintained
Evaluation Pre-Market Inspection Tests
Planing and monitoring
Records
Comittee
Pertinent guideline
Reception
Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva20 |
Examples of key findings and gaps (Inspections) / 1
Examples of key findings and gaps (Inspections) / 1
Regulation– No regulations for compliance with good manufacturing practices
(GMP) and good distribution practices (GDP)
Guideline– The available GMP guidelines are not updated to comply with WHO
guidelines.– There are no Good Distribution, Storage or Wholesaling Practice
Guidelines – Written official GMP guidelines do not exist at the moment except the
unfinished draft– There is no official National GMP guideline and the WHO GMP
guidelines have not been officially adopted, although they are being used
Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva21 |
Examples of key findings and gaps (Inspections) / 2
Examples of key findings and gaps (Inspections) / 2
Human resources– Lack of competency in GMP auditing – Limited human resources in GMP and GDP activities– Some of the staff have received limited but not adequate training in
GMP inspection. They also lack experience.– There is no legal officer in the department.– The number and skills of inspectors is not adequate, considering the
number of manufacturers to be inspected.
Independence/Impartiality– No code of conduct for inspectors– No provision or guidelines regarding conflict of interest of inspectors
exist
Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva22 |
Examples of key findings and gaps (Inspections) / 3
Examples of key findings and gaps (Inspections) / 3
QMS and SOP– No periodicity defined for performing inspection and inadequate
duration of inspection– No quality management system for inspectorate and in particular no
documented procedure for documentation control, no internal periodic review or auditing
– Documented procedure for planning, preparation, inspection and follow up not finalized
– No procedure for qualification as inspector and inspection team leader– ProcedureS for follow up of deficiencies identified during inspections
do not exist.– Written checklist and plans for inspection of manufacturers and
distribution channels are not available.
Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva23 |
Examples of key findings and gaps (Inspections) / 4
Examples of key findings and gaps (Inspections) / 4
Equipment / IT– Limited access to the internet– Inadequate logistical support i.e. communication tools on the
field, vehicles and computers
Organisation– Poor communication with the regional inspectors– No coordination or collaboration or exchange of information on
inspection activities– No mechanism to demonstrate that all inspectors in the country
follow the same procedure
Records and outcomes– No consolidated list of inspection activities performed
Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva24 |
Usefulness of indicatorsUsefulness of indicators
Marketing Authorization– Number of application received, Number of MA delivered .– Time to acknoledge receipt of application ;– Time to deliver a MA ;– Time/delay to publish MA with related Product Information.
Inspection– Number of inspection– Time between two inspections ;– Time between initial inspection and follow up inspections (in
case of non compliance)
Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva25 |
List of institutions to be visited and Personnel to be met / 1
List of institutions to be visited and Personnel to be met / 1
Ministry of Health / Ministry of industry,
Representatives of the Regulatory authority and any other organizations involved in the regulatory functions,
Staff of Regulatory authority or organization,
Representatives of the Industry Association of manufacturers, distributors, importers and exporters,
Representatives of the Professional Association of general practitioners, nurses and pharmacist,
Professionals councils (medical practitioners council, pharmacists council)
Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva26 |
List of institutions to be visited and Personnel to be met / 2
List of institutions to be visited and Personnel to be met / 2
Representatives of Consumers' associations,
Journalists.
Non-governmental associations
Procurement agencies, National medicines stores
Health research organizations
Chairmen or representatives of Advisory committee
Chairmen or representative of IRB / IEC
Representative of university academician
Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva27 |
Main source of documented evidence / 1Main source of documented evidence / 1
Regulatory authority– Act, Law, Decree or circular establishing the Regulatory authority– Corporate, strategic and business plan of the NRA– Mission, vision, objectives and indicators of the NRA, i– Quality manual,– List of Internal procedure– List of internal forms and templates– List of the fees applicable for licensing, registration or authorization– Organigram/organization charts– Code of conduct/code of ethics– List of staff with their qualification– List of external experts– Annual report, self-assessment report
Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva28 |
Main source of documented evidence / 2Main source of documented evidence / 2
Regulatory functions (Registration, Licensing, Inspection, Clinical Trail, Pharmaco-vigilance, Market control, Import Control, Quality Control Laboratory, control of drug promotion– Act, Law, Decree or circular establishing legal provisions for
each regulatory functions– Guidance published on this domain– Internal procedure– List of equipment– Job descriptions– Decision, Authorization and their annexes
Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva29 |
Issuance of RecommandationsIssuance of Recommandations
Based on the various life cycles of the activities needed such as :– To convince politicians– To change laws or decrees– To develop a guidance with consultative process– To reorganise and reshape the structure
(centralized/decentralized activities)– To implement QMS, to develop procedures and planning– To manage HR– To change records– To implement communication strategy
Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva30 |
Guidance to use this toolGuidance to use this tool
Regulatory assessment process– Main steps of a Regulatory assessment– Different categories of assessment in the time– Duration– General advice about assessment
For each regulatory function– Brief narrative description of the function– List of questions– Quantitative indicators of activities, of performances– Documented evidence to be reviewed (plan, procedures, reports, job
descriptions, etc)– References to be consulted, based on WHO bibliography
Annexes– Templates
Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva31 |
MRA assessments worldwideMRA assessments worldwide
44 Assessments performed on 40 Regulatory systems (with the involvement of HQ)
– AFRO - 21 COUNTRIES / 24 ASSESSMENTS– EURO - 2 COUNTRIES / 2 ASSESSMENTS– EMRO - 4 COUNTRIES / 5 ASSESSMENTS– SEARO - 4 COUNTRIES / 4 ASSESSMENTS– WPRO - 7 COUNTRIES / 7 ASSESSMENTS– PAHO - 2 COUNTRIES / 2 ASSESSMENTS
WHO Regional assessments– ????
Self-assessments– ???
Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva32 |
MRA assessments in AFRO regionMRA assessments in AFRO region
2008
2007
2006
2004
2003
No
2003
Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva33 |
AFRO : Outcomes / Few examplesAFRO : Outcomes / Few examples
Publication of the main drug law
01
2
34
5
67
8
Before1979
1979-19881989-19981999-20032004-2008
Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva34 |
AFRO : Outcomes / Few examplesAFRO : Outcomes / Few examples
Various kinds of MRAs
133
5
MoH
Board
Agency
Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva35 |
AFRO : Outcomes / Few examplesAFRO : Outcomes / Few examples
Committees within the marketing authorization processes
11
4
6
Committee in place
Committee not functional
No committee
Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva36 |
AFRO : Outcomes / Few examplesAFRO : Outcomes / Few examples
Not required (42%) Not published (29%)Not in line with WHO (24%) In line with WHO (5%)
GMP requirements
Alain PRAT, MRS/TCM/HSS WHO/HQ Geneva37 |
Thanks for your attention