WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies WHO Headquaters, Geneva,...

WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies

WHO Headquaters, Geneva, Switzerland31 October - 4 November 2011

Alain PRAT, Technical adviser, QSM/EMP/HSS

WHO Assessment of National Medicines Regulatory Authorities

(NMRAs)

Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva2 |

Content of the presentationContent of the presentation

Assessment tool and process

Figures and findings

Future perspectives

References

Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva3 |

Why an assessment tool ?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 decision-makers to gain support

Alain PRAT, Regulatory Support QSM/EMP/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, Regulatory Support QSM/EMP/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, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva6 |

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, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva7 |

Comprehensive scope of the toolComprehensive scope of the tool

Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva8 |

Pulse Wave Modulation

-150

-100

-50

0

50

100

150

temps

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Limited number of indicators

Example : There is or there is not a guideline on…

Level of scrutiny - Granulometry

Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva9 |

Pulse Wave Modulation

-150

-100

-50

0

50

100

150

temps

va

leu

r r

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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

Ad Qu Sa

A

Ef Sp

Level of scrutiny - Granulometry

Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva10 |

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, …

Level of scrutiny - Granulometry

Pulse Wave Modulation

-150

-100

-50

0

50

100

150

temps

va

leu

r r

ela

tiv

e

Qv

Qi

Qs

Qd

Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva11 |

Assessment strategyAssessment strategy

Guidelines

Operating proceduresTemplates

Decret / Regulation

Legislation / Act

Regulatory pyramide

Top

Down

DecisionsRecords

Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva12 |

Assessment methodologyAssessment 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 

Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva13 |

Assessment of the institution(s)Assessment of the institution(s)

Legal basis

Governance structure

Organization in place

Quality management system

Funding

Management of human resources

Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva14 |

Assessment of the institution(s)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

Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva15 |

Assessment of the NMRA processesAssessment of the NMRA processes

Processes management

Processes Service Provision

Processes Support

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

Quality Human Ress. Information Tech. Finance Communication

Strategy Governance Planification Accountability

Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva16 |

AUT

Assessment of the NMRA processes

Qualified personal

SOP implemented

Adequate legal framework

Equipments and facilities maintained

Steps in the marketing authorization process

Evaluation Inspection Tests

Records

Committee

Pertinent guidelines

Reception Decision

App

Planning

Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva17 |

Provision of an assessment reportProvision 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

Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva18 |

NMRA assessments worldwideNMRA assessments worldwide

54 Assessments performed on 49 Regulatory systems (with the involvement of who Headquaters)

– 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– ???

Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva19 |

NMRA assessments in AFRO regionNMRA assessments in AFRO region

2006

2004

2003

Non

2002

2001

2008

2007

2006

2009

2010

2011

Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva20 |

Findings: Main ActFindings: Main Act

Publication of the main law on Medicines

01

2

34

5

67

8

Before1979

1979-19881989-19981999-20032004-2008

Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva21 |

Findings: Regulatory actorsFindings: 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

Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva22 |

Findings: NMRA processesFindings: NMRA processes

Marketing authorization

Inspection

Product Information

Pharmacovigilance

Import Control

Licensing

Control Drug Promotion

Quality Control

Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva23 |

Findings : Advisory committeesFindings : Advisory committees

Committees involved in the marketing authorization processes in the AFRO region

11

4

6

Committee in place

Committee not functional

No committee

Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva24 |

Findings: GMPFindings: GMP

Not required (42%) Not published (29%)Not in line with WHO (24%) In line with WHO (5%)

GMP requirements in the AFRO region

Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva25 |

Future improvementsFuture 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

Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva26 |

Future improvementsFuture 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

Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva27 |

Future improvementsFuture improvements

Health Information

Health Financing

Health Products

Service Delivery

Leadership &

Governance

Health Workforce

Improve our integration within

the HSS six building blocks

NMRAs

Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva28 |

References on Medicines RegulationReferences 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)

Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva29 |

Thanks for your attention