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 khadembroojerdia@who.int

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

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

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.

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

Institutional Development Plan (IDP)

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

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 +

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

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

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

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

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)

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 http://epela.net

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

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

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

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

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

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

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

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

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

Nra intelligence system

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

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.

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

Related Databases NRA SharePoint: https://workspace.who.int/sites/att/default.aspx NRA Database Management: https://workspace.who.int/sites/nra_database/default.aspx

Thank You