1. The First Conference for Medicines Regulatory Authorities In Sudan and Neighboring Countries Khartoum - 6-8 December 2014 Alain PRAT, Technical Officer, RSS/EMP/HIS National Regulatory Assessment: Tool and methology

2. Alain PRAT, Regulatory System Strengthening EMP/HIS WHO/HQ Geneva 2 |2 | National Regulatory Authority An entity/organization in charge of the administration of the medicines regulation, including at least one of the following regulatory activities: –Issuing marketing authorization and dealing with variation; –Testing the Quality of products; –Monitoring adverse drug reaction and events; –Inspecting checking compliance of practices with applicable requirements and enforcement operations; –Licensing of manufacturers, wholesalers and distribution channels –Controlling medicines promotion and advertisement –Controling clinical trials including adverse reactions or events –Providing of medicines information and promotion of rational use of medicines;

3. Alain PRAT, Regulatory System Strengthening EMP/HIS WHO/HQ Geneva 3 |3 | National Regulatory System The institutional arrangements of the national and/or regional and/or local bodies/authorities in charge of implementing and supervising the medicines regulation –Department in the Ministry of Health; –Specialized Agency; –Regional authority –Pharmacy Board; –Quality control laboratories; –Pharmaceutical council –…

4. Alain PRAT, Regulatory System Strengthening EMP/HIS WHO/HQ Geneva 4 |4 | Why an assessment tool ? To provide for documented evidence on the current situation regarding the medicines regulation and its implementation by identifying strengths and weaknesses To make recommendations on identified gaps for improvement To use assessment results as a input to develop a plan of actions for the NRA In line with one of the MRS strategic objectives –To strengthen National Regulatory Authorities (NRAs) capacities

5. Alain PRAT, Regulatory System Strengthening EMP/HIS WHO/HQ Geneva 5 |5 | National Regulatory System Cartography of the authorities MoH Ministry of Health Agency or Board Regional Authority Prof. Council Ethics Committees Reg. Entities Customs Aut. Police & Courts Local Authorities PhV Cent. Qual. Cont.Lab Nat. ECs *Conformity Assessment Body Ports of entry

6. Alain PRAT, Regulatory System Strengthening EMP/HIS WHO/HQ Geneva 6 |6 | National Regulatory Authority Cartography of the processes Management Regulatory Services & Products * 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

7. Alain PRAT, Regulatory System Strengthening EMP/HIS WHO/HQ Geneva 7 |7 | NRA Assessment strategy Guidelines Operating procedures Templates Decret / Regulation Legislation / Act Regulatory pyramide Top Down Decisions Records

8. Alain PRAT, Regulatory System Strengthening EMP/HIS WHO/HQ Geneva 8 |8 | NRA 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 NRA

9. Alain PRAT, Regulatory System Strengthening EMP/HIS WHO/HQ Geneva 9 |9 | NRA Assessment Tool Design Module for reviewing the institution / 1 Legal basis Governance & Organizational structure Strategic planning Quality & Risk management system Management of finances (Fees) Management of human resources Partnership and collaboration

10. Alain PRAT, Regulatory System Strengthening EMP/HIS WHO/HQ Geneva 10 | NRA Assessment Tool Design Module for reviewing the institution / 2 Independence and impartiality Transparency and confidentiality Management of committees and external expertise Management of infrastructure and equipment Knowledge and IT Management Monitoring and accountability Communication

11. Alain PRAT, Regulatory System Strengthening EMP/HIS WHO/HQ Geneva 11 | NRA Assessment Tool Design Generic format for assessing regulatory functions Legal basis (Act, Regulation or statutory instruments) Guidelines, Norms and Standards Procedures and records Human and other Resources Decisions and others outputs Outcomes

12. Alain PRAT, Regulatory System Strengthening EMP/HIS WHO/HQ Geneva 12 | Limited number of indicators Example : Is there any guidelines on medicine registration? NRA Assessment Tool – Granularity / 1

13. Alain PRAT, Regulatory System Strengthening EMP/HIS WHO/HQ Geneva 13 | Increased number of indicators on the same subject Example : Is the guidelines dealing with the following aspects: Administrative part, Quality part, Safety part, Efficacy part, Product Information Ad Qu Sa EfPI NRA Assessment Tool – Granularity / 2

14. Alain PRAT, Regulatory System Strengthening EMP/HIS WHO/HQ Geneva 14 | References used as a basis for NRA Assessment Consolidated regulatory framework developed by WHO in various guidelines and books –Based on WHO National Drug Regulatory Legislation published in WHO TRS N°885 Consolidated a list of norms, standards and guidelines which should be (ideally) implemented –WHO, ICH, GHTF, ISO and Others

15. Alain PRAT, Regulatory System Strengthening EMP/HIS WHO/HQ Geneva 15 | NMRA assessments in AFRO region 2004 2003 No 2002 2001 2008 2007 2006 2009 2010 2011 2012 2013 2014

16. Alain PRAT, Regulatory System Strengthening EMP/HIS WHO/HQ Geneva 16 | Thanks for your attention