1. Lahouari Belgharbi, WHO/EMP/HQ THE OBJECTIVES AND DEVELOPMENT OF A JOINT NRA ASSESSMENT TOOL Update on harmonization of WHO/PAHO NRA assessment process for assessment of medicines, vaccines, medical devices and diagnostics

2. HISTORY …OF WHO ASSESSMENTS RELEVANT TO MEDICINAL PRODUCTS, DIAGNOSTICS AND MEDICAL DEVICES INCLUDING BLOOD AND VACCINES: REVISION OF TOOLS 1.Vaccines 2.Vaccines 4.Vaccines 5.Vaccines 2.Medicines 1.Blood 6.Vaccines 1.Medical devices 1.Medicines 1.Diagnostics 2.Medical devices 1.PAHO Harmonized tool harmonization Medicines/vacc ines Medical Devices & Diagnostics 7.Vaccines 3.Vaccines 1997 1999 2000 2001 2002 2004 2007 2010 2011 2012 2013 2014

3. HARMONIZED TOOL: REGULATORY FUNCTIONS 1. NATIONAL REGULATORY SYSTEM 2. REGISTRATION AND MARKETING AUTHORIZATION 3. LICENSING ACTIVITIES 4. POST-MARKETING SURVEILLANCE (+ LOT RELEASE FUNCTION) 5. OVERSIGHT OF CLINICAL TRIALS 6. INSPECTIONS AND ENFORCEMENT ACTIVITIES 7. LABORATORY ACCESS AND TESTING 8. VIGILANCE AND RISK MANAGEMENT 9. CONTROL OF PROMOTION AND ADVERTISING 10. CONTROL OF NARCOTICS, PSYCHOTROPIC SUBSTANCES AND PRECURSORS 11. PHARMACEUTICAL PERSONNEL

4. PAHO TOOLMEDICINES TOOLMEDICAL DEVICES & DIAGNOSTICS VACCINES TOOL WHO-PAHO HARMONIZED TOOL 1. SISTEMA NACIONAL DE REGULACIÓN Module 2 - NATIONAL REGULATORY SYSTEM NRS: NATIONAL REGULATORY SYSTEM RS: NATIONAL REGULATORY SYSTEM 1.NATIONAL REGULATORY SYSTEM 2. AUTORIDAD REGULADORA NACIONAL Module 3 - NATIONAL REGULATORY AUTHORITY 3. REGISTRO SANITARIOModule 4 - MARKETING AUTHORIZATION MA: MARKETING AUTHORIZATION (MA) FOR MEDICAL DEVICES AND DIAGNOSTICS FUNCTION 1: MARKETING AUTHORIZATION AND LICENSING ACTIVITIES 2.REGISTRATION AND MARKETING AUTHORIZATION 4. LICENCIAMIENTO DE PRODUCTORES Module 5 - LICENSING OF MANUFACTURERS LI: LICENSING OF MANUFACTURERS, IMPORTERS, DISTRIBUTERS AND RETAILERS OF MEDICAL DEVICES AND DIAGNOSTICS 3.LICENSING ACTIVITIES Module 6 - LICENSING OF IMPORTERS, EXPORTERS, WHOLESALERS AND DISTRIBUTORS Module 7 - LICENSING OF PHARMACIES AND RETAIL OUTLETS Module 8 - REGISTRATION OF PHARMACY PERSONNEL 11.PHARMACEUTICAL PERSONNEL (HEALTH/REGULATORY??) Regulatory functions: former and harmonized tool

5. PAHO TOOLMEDICINES TOOLMEDICAL DEVICES & DIAGNOSTICS VACCINES TOOLWHO-PAHO HARMONIZED TOOL 5. VIGILANCIA DEL MERCADOModule 9 - POST-MARKETING SURVEILLANCE AND CONTROLS PMS: POST- MARKETING SURVEILLANCE FUNCTION 2: POST-MARKETING ACTIVITIES INCLUDING SURVEILLANCE OF ADVERSE EVENTS FOLLOWING IMMUNIZATION (AEFI) 4.POST-MARKETING SURVEILLANCE (includes vaccine lot release function) 6. FARMACOVIGILANCIAModule 11 - PHARMACOVIGILANCE VR: VIGILANCE AD RISK MANAGEMENT ACTIVITIES ON MEDICAL DEVICES AND DIAGNOSTICS 8.VIGILANCE AND RISK MANAGEMENT Module 10 - CONTROL OF MEDICINES PROMOTION AND ADVERTISING PR: CONTROL OF PROMOTION AND ADVERTISSEMENT FOR HEALTH PRODUCTS 9.CONTROL OF PROMOTION AND ADVERTISING 7. CONTROL DE ENSAYOS CLÍNICOS Module 12 - CLINICAL TRIALSCT: OVERSIGHT OF CLINICAL TRIALS on IVDs and MD FUNCTION 6: REGULATORY OVERSIGHT OF CLINICAL TRIALS 5.OVERSIGHT OF CLINICAL TRIALS 8. INSPECCIONES REGULADORAS Y ACTIVIDADES DE FISCALIZACION Module 13 - REGULATORY INSPECTIONS AND ENFORCEMENT ACTIVITIES IE: INSPECTIONS AND ENFORCEMENT ACTIVITIES FUNCTION 5: REGULATORY INSPECTIONS 6.INSPECTIONS AND ENFORCEMENT ACTIVITIES 9. LABORATORIO NACIONAL DE CONTROL DE CALIDAD Module 14 - QUALITY CONTROL LABORATORY LABORATORY ACCESS AND TESTING FUNCTION 4: LABORATORY ACCESS 7.LABORATORY ACCESS AND TESTING FUNCTION 3: NRA LOT RELEASE Module 15 - CONTROL OF NARCOTICS, PSYCHOTROPIC SUBSTANCES AND PRECURSORS 10.CONTROL OF NARCOTICS, PSYCHOTROPIC SUBSTANCES AND PRECURSORS Module 16 - INTERNATIONAL COOPERATION AND HARMONIZATION Regulatory functions: former and harmonized tool

6. HARMONIZED PROCESS TO STRENGTHEN NRA : THE WHO NRA 5 STEP CAPACITY BUILDING RECOMMENDED PROCESS 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 12 34 5 Revision of indicators & assessment process Every 2-3 years, Harmonization of tools Revision of indicators & assessment process Every 2-3 years, Harmonization of tools Re-assessment Every 2,3 or 5years Re-assessment Every 2,3 or 5years Self assessment For planning formal assessment Self assessment For planning formal assessment With or without A road map for prequalification of products With or without A road map for prequalification of products WHO support through Global Learning Opportunities (GLO) & ROs WHO support through Global Learning Opportunities (GLO) & ROs WHO electronic platform to monitor NRAs informaiton and assessment reports, IDP, training, manufacturers, etc

7. Gap analysis Assessment & Self assessment of NRAs functions Addressing the gaps Institutional Development Plan (IDP) to recommend actions Monitoring progress and impact IDP follow-up visits Re-assessment Observed audits STRENGTHENING REGULATORY CAPACITY Self assessment workshop Global Learning Opportunities (GLO) In-county workshop Coached audit Regulatory functions targeted: 1.NATIONAL REGULATORY SYSTEM 2.REGISTRATION AND MARKETING AUTHORIZATION 3.LICENSING ACTIVITIES 4.POST-MARKETING SURVEILLANCE ( + LOT RELEASE FUNCTION) 5.OVERSIGHT OF CLINICAL TRIALS 6.INSPECTIONS AND ENFORCEMENT ACTIVITIES 7.LABORATORY ACCESS AND TESTING 8.VIGILANCE AND RISK MANAGEMENT 9.CONTROL OF PROMOTION AND ADVERTISING 10.CONTROL OF NARCOTICS, PSYCHOTROPIC SUBSTANCES AND PRECURSORS 11.PHARMACEUTICAL PERSONNEL

8. NEXT STEPS… Finalized tool by end of sept.2013 Computerized tool by Oct.2013 Electronic platform for planning and conducting assessment by Oct.2013 Tested in Mexico by end of Jan.2014, then in South Africa (2014), Senegal (2014), Brazil (2014), Viet Nam (2014). Planning for 2014-1015 assessment : Nov.2013 Integration of Blood and potentially traditional medicines by end of the biennium 2015.