Update from GMP – Malaria Prevention, Diagnostics and Treatment Silvia Schwarte Prevention, Diagnostics and Treatment Interagency Pharmaceutical Coordination (IPC) Group Meeting World Bank, Washington, USA, 6-7 June 2016

Outline Past trends, current achievements, future goals Prevention  RTS,S/AS01 vaccine Diagnosis  Round 6 Report – WHO selection criteria product update  Procurement criteria – WHO PQ Treatment  New quality-assured medicines

MDG 6 target – to halt and reverse the incidence of malaria – has been achieved

20 April 2016: The WHO European Region is malaria free Ahead of World Malaria Day 2016, WHO announces that the European Region hit its 2015 target to wipe out malaria, thus contributing to the global goal to "End malaria for good". Global Technical Strategy

 Jul 2015: Positive Scientific Opinion by EMA (Article 58)  Oct 2015: SAGE / MPAC: evidence review for global policy recommendation => large-scale implementation pilots  parts of 3-5 sub-Saharan African countries  administering 3 doses of the vaccine to children aged 5-9 months with a fourth dose months later  mortality impact  meningitis and cerebral malaria => pilots to generate evidence for decision-making about potential wider scale use of RTS,S in 3-5 years' time  Jan 2016: WHO issues first position paper on a malaria vaccine ( RTS,S/AS01 malaria vaccine

Performance evaluation of malaria RDTs: Round 6 report published – WHO selection criteria updated Since 2009: WHO Malaria RDT Product Testing Programme

Changes to WHO criteria on RDT procurement (I) 12 malaria RDTs from 4 manufacturers are WHO prequalified:  7 Pf-only  4 Pf and non-Pf  1 all species (but does not distinguish between them) Products accessible at: /rdt-procurement-criteria/en/

Timelines  For products that are currently eligible for WHO procurement, manufacturers must submit a WHO PQ pre- submission form to WHO PQT by 31 July  For products that are new to WHO processes or for products that are due for compulsory resubmission to Product Testing, manufacturers must submit to the revised EOI for Round 8, in quarter 4 of  Manufacturers are expected to have submitted a complete dossier for each product to WHO PQT by 31 December  Manufacturers are expected to complete full prequalification by 31 December Beyond this date only prequalified products will be recommended and eligible for WHO procurement. Changes to WHO criteria on RDT procurement (II)

Quality-assured antimalarial medicines (last updated 3 June 2016)  Fixed-dose combinations (FDCs) - AL 20/120mg: Ajanta, Cipla, Ipca, Macleods, Mylan, Novartis, Strides - AL 20/120mg dispersibles: Ajanta, Novartis - AL 40/240mg: Mylan - AL 80/480mg: Novartis - ASAQ: Ajanta, Cipla, Guilin, Ipca, Sanofi - ASMQ: DNDi/Cipla - DHA-PPQ (20/160mg, 40/320mg): Sigma-Tau  Co-Blisters (Co-B) - AS + AQ: Cipla, Guilin, Ipca, Strides - AS + SP:Guilin  Injectables - AS (30/60/120mg)powder for inj: Guilin  SP + AQ ( mg, /250mg): Guilin  Primaquine (7.5mg, 15mg): Remedica, Sanofi  Chloroquine: Alliance Pharma, Remedica, Sanofi  SP (500/25mg):Guilin, Remedica  black: WHO prequalified + GF list  green: on GF list only  bold: single-source supplies  new since mid 2015

Thank you very much for your attention

Backup slides

WHO prequalified malaria RDTs