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Update From GMP - Malaria Prevention, Diagnostics and Treatment
Update From GMP - Malaria Prevention, Diagnostics and Treatment
Silvia Schwarte
Prevention, Diagnostics and Treatment
e-mail: [email protected]
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
9:
Since 200 ting Programm
e
o du ct Te s
HO M a laria RDT Pr
W
Changes to WHO criteria on RDT procurement (I)
http://www.who.int/diagnostics_laboratory/evaluations/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 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)
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