1. World Health Organization
1 April, 2017
WHO PROGRAMME
FOR STRENGTHENING NATIONAL REGULATORY AUTHORITIES IN THE AREA OF VACCINE
WHO Technical Briefing Seminar on Essential Medicines and Health Products
CAPACITY BUILDING
HIS/EMP/RHT/RSS
Presented by: Dr Alireza Khadem

2. Outline
Background
WHO policy to strengthen NRAs in the area of vaccines
Capacity building process
Institutional Development Plan (IDP)
China success story
Strengthening the Regulatory Inspection Function
Parallel review
Global Learning Opportunities (GLO)
Facts and Figures
NRA Intelligence system

3. World Health Organization
Background
World Health Organization
1 April, 2017
WHO developed a programme to strengthen the national regulatory capacity in the area of vaccines and biologicals. The programme conducted assessment to identify gaps and used the Global Training Network (GTN) to provide capacity building support.
Prequalification of vaccines were linked to NRA functionality assessed by WHO.
WHO started the vaccine prequalification programme to assist countries to procure assured quality vaccines for their national immunization.
The World Health Organization (WHO) has developed, since 1996, a programme to strengthen the national regulatory capacity in the area of vaccines and biologicals. This programme started with the establishment of a Global Training Network (GTN) and country assessment of National Regulatory Authorities (NRAs) through the development of an Institutional Development Plan (IDP) to identify political commitment, prioritize technical and financial support and develop regulatory systems against international standards of safety, quality and efficacy of medicines, including vaccines.
One main focus of the WHO strengthening programme was to assess vaccine regulatory agencies against an international benchmark (NRA assessment tools) to guide government to regulate imported and domestic vaccine production and contribute to the sustainability and development of assured quality vaccine production in developing countries (high, middle and low income countries). Approximately 102 countries have been assessed against the WHO NRA published indicators.
1987
1996
2004

4. WHO NRA 5 step capacity building
Bench Marking
Development of NRA assessment tool
Assessment of NRA
Development of Institutional
Development Plan (IDP)
Providing technical support, Training/Learning, networking,
Monitoring progress and impact
Functional NRA 1 2 3 4 5
With or without a road map for prequalification of products
Revision of indicators & assessment process (Every 2-3 years)
Harmonizati on of tools
Re-assessment
Every 2-5 years
Self assessment for planning formal assessment
WHO support through:
Global Learning Opportunities (GLO)
Technical Support
In-country training
WHO electronic platform to monitor NRAs information and assessment reports, IDP, training, etc.

5. Capacity Building Process
Gap analysis
Assessment
IDP
A plan for addressing the identified gaps
Addressing the gaps
Providing technical support
Training
Monitoring progress and impact
IDP follow-up
Reassessment
Global Learning Opportunities (GLO)
In-county workshop
Technical Support

6. Institutional Development Plan (IDP)

7. China: The Success Story
NRA Assessment
Functional NRA, after assessment in Dec 2010
NRA Re- Assessment
IDP
IDP
2005
Mar/2011
Oct/2013
Q2/2014

8. Raising inspections performances: enforcement, competencies and skills
Bench Marking
Development of NRA assessment tool
Assessment of NRA
Development of Institutional
Development Plan (IDP)
Providing technical support, Training/Learning, networking,
Monitoring progress and impact
Functional NRA 1 2 3 4 5
Coached Audit
Basic and Advanced Regulatory Inspection Workshop + technical support
+ Observed Audit
Develop a response to address the gaps of both inspectorates and inspectors
Performance evaluation of GMP inspectorate (GAP analysis)
Performance evaluation of regulatory inspectors +

9. Regulatory Inspection Strengthening Process
Gap analysis
Assessment
Observed audit
IDP
A plan for addressing the identified gaps
Addressing the gaps
Providing technical support
Training
Monitoring progress and impact
IDP follow-up
Reassessment
Global Learning Opportunities (GLO)
In-county workshop
Coached audit
Agreed agenda (WHO and NRA)
Pre and post workshop assessment
Mixture of participants: regulators (NRA, NCL) and manufacturers
Mock inspection (planning, conducting, reporting)
Feedback by facilitators

10. Developed courses
GMP regulatory inspection using the quality risk management approach (Basic and Advanced)
Parallel review
Manufacturing and control of Influenza vaccine
Marketing Authorization Workshops for Vaccine Licensing
Adverse Effects Following Immunization
NRA planning workshop to strengthen the vaccine regulatory system

11. Activities conducted: 2010 to 2013
Country
Year
Month
Activity
NOP
Cuba
2013
November
Regulatory Inspection Workshop (Advanced-QRM) 24
India
September
Regulatory Inspection Workshop (Basic) 22
Brazil
August
China
June 36
May 27
Mar 30
Iran
Feb 26
2012
Dec
Viet Nam
Nov 32
Oct
Sep
Observed Audit 13 6
Apr
Coached Audit 5
2011
2010
Jul
Jun 23 9
2009 10

12. Parallel review: steps
WHO receive a request from a "developing NRA"
WHO inform both NRAs
About the process and request
confidentiality agreement &
Commitment in writing
WHO Seek for
a "leading NRA"
2nd Training on vaccine evaluation
1st training on vaccine evaluation Principles and process
Parallel review conducted
1- 3 months
3-6 months

13. Global Learning Opportunities
ACTIVE COURSES
Legislation for clinical trials (ENG) FRE in process
Clinical trails authorization (ENG) Indonesia and South Africa
Good clinical practices inspections (ENG), Indonesia
Evaluation of clinical data (ENG), Indonesia
Product evaluation (ENG)
Good manufacturing practices (ENG)
Pharmaceutical cold chain management on wheels (ENG) Turkey, Greece
Facilitation skills (ENG and FRE)
Designing courses for learning (ENG)

14. Global Learning Opportunities
AUTHENTIC E-LEARNING
Launched in March 2013
Currently running e- Pharmaceutical cold chain management
e-VVM based vaccine management to be launched in January 2014
Coming courses: Quality risk management and GCP inspections

15. Training
*Global Training Network, **National Control Laboratory, §Expanded Programme on Immunization
§§Vaccine Manufacturers
Source: World Health Organization/Essential Medicines and Health Products, as of 4 March 2013

16. Training
*Global Training Network, **National Control Laboratory, §Expanded Programme on Immunization
§§Vaccine Manufacturers
Source: World Health Organization/Essential Medicines and Health Products, as of 4 March 2013

17. Training *National Control Laboratory
**Expanded Programme on Immunization
Source: World Health Organization/Essential Medicines and Health Products, as of 4 March 2013

18. Training
*National Control Laboratory, **Expanded Programme on Immunization, §Vaccine Manufacturers
Source: World Health Organization/Essential Medicines and Health Products, as of 4 March 2013

19. Training
*National Control Laboratory, **Expanded Programme on Immunization, §Vaccine Manufacturers
Source: World Health Organization/Essential Medicines and Health Products, as of 4 March 2013

20. Training
*National Control Laboratory, **Expanded Programme on Immunization, §Vaccine Manufacturers
Source: World Health Organization/Essential Medicines and Health Products, as of 4 March 2013

21. Training
*National Control Laboratory, **Expanded Programme on Immunization, §Vaccine Manufacturers
Source: World Health Organization/Essential Medicines and Health Products, as of 4 March 2013

22. Training
*National Control Laboratory, **Expanded Programme on Immunization, §Vaccine Manufacturers
Source: World Health Organization/Essential Medicines and Health Products, as of 4 March 2013

23. Training
*National Control Laboratory, **Expanded Programme on Immunization, §Vaccine Manufacturers
Source: World Health Organization/Essential Medicines and Health Products, as of 4 March 2013

24. Nra intelligence system

25. Database modules NRA SharePoint
NRA Planning/Monitoring System & Expert Modules
NRA Assessment Modules
Lot Release & Vaccine
NRA Training Database
GMP Database

26. Data management and monitoring:
Benchmarking: Generic assessment tools
Planning and conducting assessment: NRA planning, NRA assessment report
Identifying gaps and strengths through assessment: NRA assessments report, IDP, GMP
Providing technical support including training: NRA training monitoring, IDP
Monitoring progress and impact and follow up: IDP, Lot release, vaccine doses.

27. Database modules NRA Assessment Lot Release NRA Planning CV Vaccine
Expert DB
IVB
NRA Assessment
NRA Team
IDP
Generic tools
NRA Planning
Work plan
Activity CV
NRA Training
Trainees
Training Centers
Lot Release
Certificate
Vaccine
GMP
NRA country Profile
Training
Activities
Assessment

28. Related Databases
NRA SharePoint:
NRA Database Management:

29. Thank You