1. WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies WHO Headquaters, Geneva, Switzerland 31 October - 4 November 2011 Alain PRAT, Technical adviser, QSM/EMP/HSS WHO Assessment of National Medicines Regulatory Authorities (NMRAs)

2. Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva 2 |2 | Content of the presentation Assessment tool and process Figures and findings Future perspectives References

3. Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva 3 |3 | 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

4. Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva 4 |4 | Main 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

5. Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva 5 |5 | Main 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

6. Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva 6 |6 | Design 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

7. Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva 7 |7 | Comprehensive scope of the tool

8. Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva 8 |8 | Limited number of indicators Example : There is or there is not a guideline on… Level of scrutiny - Granulometry

9. Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva 9 |9 | 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

10. Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva 10 | 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 Qv Qi Qs Qd

11. Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva 11 | Assessment strategy Guidelines Operating procedures Templates Decret / Regulation Legislation / Act Regulatory pyramide Top Down Decisions Records

12. Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva 12 | Assessment 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

13. Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva 13 | Assessment of the institution(s) Legal basis Governance structure Organization in place Quality management system Funding Management of human resources

14. Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva 14 | 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

15. Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva 15 | Assessment 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 StrategyGovernancePlanificationAccountability

16. Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva 16 | AUTAUT Assessment of the NMRA processes Qualified personal SOP implemented Adequate legal framework Equipments and facilities maintained Steps in the marketing authorization process EvaluationInspectionTests Records Committee Pertinent guidelines ReceptionDecision AppApp Planning

17. Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva 17 | Provision 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

18. Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva 18 | NMRA 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 –???

19. Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva 19 | NMRA assessments in AFRO region 2006 2004 2003 Non 2002 2001 2008 2007 2006 2009 2010 2011

20. Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva 20 | Findings: Main Act Publication of the main law on Medicines

21. Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva 21 | Findings: Regulatory actors AAAAAAAA Marketing authorization ABAAABAB Licencing AAABACBC Inspection AABCBDCD Quality Control AAAACADE Pharm.Vigilance 12233445 Nb of NMRA 32614221 Number of countries

22. Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva 22 | Findings: NMRA processes Marketing authorization Inspection Product Information Pharmaco vigilance Import Control Licensing Control Drug Promotion Quality Control

23. Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva 23 | Findings : Advisory committees Committees involved in the marketing authorization processes in the AFRO region

24. Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva 24 | Findings: GMP GMP requirements in the AFRO region

25. Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva 25 | Future 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

26. Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva 26 | Future 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

27. Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva 27 | Future improvements Health Information Health Financing Health Products Service Delivery Leadership & Governance Health Workforce Improve our integration within the HSS six building blocks NMRAs

28. Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva 28 | References 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)

29. Alain PRAT, Regulatory Support QSM/EMP/HSS WHO/HQ Geneva 29 | Thanks for your attention