REGULATORY SYSTEMS STRENGHTHENING Feedback on the 2 nd WHO International Consultation for Strengthening National Regulatory Systems HIS/EMP/RHT/RSS

REGULATORY SYSTEMS STRENGHTHENING

Feedback on the 2nd WHO International Consultation for Strengthening National Regulatory Systems

HIS/EMP/RHT/RSS

|

2 |

OutlineOutline

1. Between the 1st and the 2nd International Consultations

2. Discussions of the 2nd International Consultation

3. Outcomes and next steps

|

3 |

OutlineOutline

1. Between the 1st and the 2nd International Consultation



WHO role is to focus on improved accessto health products and health technologies

IDPs

(country plan)

Assessment of

National Regulatory System

Benchmarking

(Assessment tool)

Alignment of EMP strategic direction against WHO reform

agenda & WHA resolutions

Contribute to the achievement of the WHO leadership priorities, such as :

(1) Universal Health Coverage

(2) The acceleration of achievement of the MDG goals expected for end 2015

(3) The reduction of deaths from “non-Communicable diseases”

2014-2019: As approved in May 2013. By the WHA66.

WHA

67.20

WHA

67.22

WHA

67.21

WHA 67.23

WHA

67.18

Others

9 (nine) World Health Assembly (WHA) resolutions target

Regulatory Systems

|

5 |

Development of the Global ToolDevelopment of the Global Tool

Vaccine 2011

Medicine 2007

Harmonized tool Prototype I

PAHO 2012

May 2014Jun 2013 Dec 2014

Harmonized tool Prototype I

Discussion

Global tool Prototype II

Jul 2015

As part of preparatory work for IC

Istanbul workshop to implement IC recommenda-

tion

Refining the tool and develop

prototype II Rev.2

Field test in 4 countries

Informal consultation

meeting, Geneva,

June 2013

Nov 2015

1st IC 2nd IC

6 |

Regulatory Systems Functions and Maturity LevelRegulatory Systems Functions and Maturity Level

National Regulatory System (NRS)

Licensing premises (LIC)

Inspection & Enforcement (INE)

Laboratory access and Testing (LAT)

Clinical Trial’s Oversight (CTO)

Vigilance (VIG)

Registration & marketing authorization (RMA)

Control of Narcotics, Psychotropic & Substances and precursors (NPSP)

Market surveillance and Control (MSC)

Elements to be considered under relevant functions

Maturity level

PHASE 1 PHASE 2

1 5

BEST IN CLASS PERFORMANCE

NO FORMAL APPROACH

NRA Lot release (LTR)Registration of health personnel (RHP)

7 |

II – METHODOLOGY & PROCESS

I - POLICY

III- BENCHMARKING SYSTEM

IV - TERMINOLOGY

1st International Consultation Implementation: Action taken (Feb-Nov.2015)


8 |

I - POLICY



1. Prioritization

2. Minimal capacity

3. Reliance

4. Publication of results

5. Linking maturity level to PQ

6. Joint Working Group (JWG)

7. Coordination with WHO experts committees (ECBS, ECSPP, BRN).

8. Good Regulatory Practices (GRP)

9. Expectation for Phase II benchmarking system

Model proposed

Model proposed

Model proposed

Model proposed

Model proposed

Pathway

Coordination

Road Map

Coordination

9 |

II – METHODOLOGY & PROCESS



1. Manual for assessment

2. Manual for self assessment workshop

3. Guidance for assessment

4. Re-assessment

5. Ensuring consistency of the new benchmarking methodology against ISO 19011:2011

Model proposed

Manual

Inventory

Manual

Quality assurance

10 |

III- BENCHMARKING SYSTEM



1. Mapping of current tools

2. Computerized system for integrating new tools

3. Finalization of the phase 1 Tool & alignment against WHO, PAHO, PICs tools, ISO standard, and SSFFC indicators

4. Expert consultation to develop Medical device tool

5. Piloted tool in China, Mexico, Saudi Arabia, and Jordan.

6. Refinement of the tool to ensure consistency and coherence.

7. Model to apply the maturity level concept

8. Update WHO observed audit manual and develop a computerized tool

WHO Global Benchmarking Tool:

Phase I

11 |

IV - TERMINOLOGY



1. Gathering terminology from relevant areas of work

2. Updating existing inventoryInventory

12 |

WHO 2nd International Consultation:

WebEx discussions and Meetings conductedJune, Aug, and 13 Nov.- 4 December 2015

Meetings in Geneva30th Nov-4 Dec.

Jun Aug 13 17 18 19 24 25 26

WHOROs

NRAs ‘meetingDonorsTechnicalPartners

WebEx sessions13 Nov-27 Nov.

Policy

November December30 1 2 3 4

MethodologyProcess

Tools & Indicators

Methodology

Tool

Policy

1A1B

4A4B

3A3B

2A2B

5A5B

6A6B

7A7B

WrapUp

JWG

27

WrapUp

JWG

WrapUp

JWGWhite Paper

13 |

SEAR 16%

EMR 16%

WPR 12%

WHO NRA 2nd International Consultation, 2015

Countries’ participation per WHO region 13 - 26 Nov, 2015

WHO NRA 2nd International Consultation, 2015

Countries’ participation per WHO region 13 - 26 Nov, 2015

Denominator= 24 countries

Country WHO Region

South Africa AFRZimbabweArgentina

AMRPAHO

BrazilCanadaColombiaCubaMexico USA Egypt

EMRIran Pakistan

Saudi ArabiaEMA

EUR

Albania

Italy

Lithuania

France

Indonesia

SEARSri Lanka

Thailand

India

China

WPRJapan

Korea

AMR 28%

EUR 20%

AFR 8%

14 |

WHO NRA 2nd international consultation, 2015 Webex consultation: 7 sessions

13 - 26 November 2015

WHO NRA 2nd international consultation, 2015 Webex consultation: 7 sessions

13 - 26 November 2015

South Afri

ca

Zimbabwe

Argentina

Brazil

Canada

ColombiaCuba

Mexico USA

Egy

ptIra

n

Pakist

an

Saudi A

rabia

AlbaniaIta

ly

Lithuania

EMAFra

nce

Indonesia

Sri La

nka

Thailand

IndiaChina

Japan

Korea0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

AFR AMR EMR EUR SEAR WPR

|

15 |

OutlineOutline




2nd International Consultation, 2015

Objectives & & DeliverablesSeek advice to proceed with the piloting of the WHO phase 1 Global benchmarking tool and to conclude the integration of other tools and products with the objective of strengthening National Regulatory Systems for all health products and technologies

Advise the World Health Organisation (WHO) about the implementation of the WHA resolution 67.20

Provide guidance for the development of phase II benchmarking/assessment tool for advanced/stringent regulatory systems

Discuss and agree on way forward on the concept of the Centres of Excellence (CoE) to build upon the Reference NRA concept using similar PAHO approach

WHO global benchmarking tool to be used by all NRAs or institutions conducting NRA benchmarking

Recommendations to meet Member States’ expectations

Road map and timeline for the development of the phase II benchmarking/assessment tool

Agreement to move forward and to finalize and/or submit a final proposal to be endorsed at global level by Member States.

Objective 1

Objective 2

Objective 3

Objective 4

Deliverables 1

Deliverables 2

Deliverables 3

Deliverables 4


Discussions Support for CATEGORIZING REGULATORY SYSTEMS ACCORDING TO

LEVELS OF MATURITY/PERFORMANCE that …• … establishes a level that is considered to fulfill WHA 67.20, and

• … also recognizes more advanced regulatory levels of performance.

Support for a SINGLE WHO BENCHMARKING TOOL and policy for use by the WHO and/or other organizations that allows for use across product lines.

Support in principle for WHO efforts to promote a more STRATEGIC, EFFECTIVE AND COORDINATED APPROACH to regulatory system strengthening through a COALITION OF TRUSTED TECHNICAL PARTNERS based on similar standards/approach and a single institutional development plan.


Discussions Support for an ABRIDGED TOOLS of regulatory systems benchmarking

that takes account the work done by other organizations.

Support for increased TRANSPARENCY, including with respect to:• Publishing information related to NRA assessments (based on the consent),

• The operations and work products of regulatory authorities, and

• The process for establishing and evaluating reliance.

Support for a TRANSPARENT METHOD/TOOL FOR PRIORITIZATION of the benchmarking/assessment of regulatory systems that is not overly complex and that takes into consideration qualitative measures.


Discussions Reliance

• Recognition that reliance/cooperation is increasingly important in helping to fulfill regulatory mandates

• Acknowledgement that a regulator may be considered ‘functional’ even if relying on others for certain regulatory functions

• Support for developing WHO guidance and tools to assist member states in promoting a sound, pragmatic and transparent approach to establishing suitable forms of reliance

• Such guidance would form part of a Good Regulatory Practices framework and would define terms and principles to consider in relying on the output of an external body (“supplier control”)

• WHO benchmarking/assessment tool must be able to evaluate the appropriateness of one authority’s reliance in another’s work

|

20 |

OutlineOutline




|

21 |

Actions for WHOActions for WHO

PILOTING AND IMPLEMENTING WHO global benchmarking tool to meet WHA 67.20 for medicines and vaccines product streams

Finalize the MEDICAL DEVICES TOOL as part of the Global Benchmarking Tool

Develop and implement proposal on the publication and sharing of information on the outcomes of benchmarking/assessment, including a GLOBAL ELECTRONIC PLATFORM accessible to NRAs (and others)

Develop GUIDANCE to promote and a tool to measure RELIANCE (under umbrella of Good Regulatory Practices framework)

|

22 |

Keep yourself updated: WHO HIS/RSS Mobile ApplicationKeep yourself updated: WHO HIS/RSS Mobile Application

Thank You

Documents

REGULATORY SYSTEMS STRENGHTHENING Feedback on the 2 nd WHO International Consultation for Strengthening National Regulatory Systems HIS/EMP/RHT/RSS