Update from GMP – Malaria

Prevention, Diagnostics and Treatment

Interagency Pharmaceutical Coordination (IPC) Group Meeting
World Bank, Washington, USA, 6-7 June 2016

Silvia Schwarte
Prevention, Diagnostics and Treatment
e-mail: schwartes@who.int
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
Global Technical Strategy 2016-2030

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".
RTS,S/AS01 malaria vaccine

 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 15-18 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 (http://www.who.int/entity/wer/2016/wer9104.pdf?ua=1)
Performance evaluation of malaria RDTs:
Round 6 report published – WHO selection criteria updated

9:
Since 200 ting Programm
e
o du ct Te s
HO M a laria RDT Pr
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Changes to WHO criteria on RDT procurement (I)

http://www.who.int/diagnostics_laboratory/evaluations/en/

12 malaria RDTs from 4 manufacturers are

WHO prequalified: Products accessible at:
http
 7 Pf-only ://www.who.int/malaria/news/2016/rdt-p
rocurement-criteria/en
 4 Pf and non-Pf /
 1 all species (but does not distinguish
between them)
Changes to WHO criteria on RDT procurement (II)

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 2016.
 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 2016.
 Manufacturers are expected to have submitted a complete
dossier for each product to WHO PQT by 31 December 2016.
 Manufacturers are expected to complete full prequalification by
31 December 2017. Beyond this date only prequalified products
will be recommended and eligible for WHO procurement.
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  blac
k:
 gre WHO prequalifie
en : o n G
 bol F list onl d + GF list
 Injectables d: s y
 new ingle-source sup
since mi plies
- AS (30/60/120mg)powder for inj: Guilin d 2015

 SP + AQ (76.5+25012.5mg, 153+500/250mg): Guilin

 Primaquine (7.5mg, 15mg): Remedica, Sanofi
 Chloroquine: Alliance Pharma, Remedica, Sanofi
 SP (500/25mg): Guilin, Remedica
Thank you very much
for your attention
Backup slides
WHO prequalified malaria RDTs