Update from GMP – Malaria - PowerPoint Presentation

Slide1

Update from GMP – Malaria Prevention, Diagnostics and Treatment

Silvia Schwarte Prevention, Diagnostics and Treatment e-mail: schwartes@who.int

Interagency Pharmaceutical Coordination (IPC) Group Meeting

World Bank, Washington, USA, 6-7 June 2016Slide2

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 medicinesSlide3

MDG 6 target –

to halt and reverse the incidence of malaria – has been achievedSlide4

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 2016-2030Slide5

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 latermortality impactmeningitis 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)

RTS,S/AS01 malaria vaccineSlide6

Performance evaluation of malaria RDTs:

Round 6 report published – WHO selection criteria updated

Since 2009:

WHO

Malaria RDT Product Testing

ProgrammeSlide7

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)

P

roducts

accessible at

:

http

://www.who.int/malaria/news/2016/rdt-procurement-criteria/en

/

http

://

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

Slide8

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. Changes to WHO criteria on RDT procurement (II)Slide9

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-TauCo-Blisters (Co-B) - AS + AQ: Cipla, Guilin, Ipca, Strides - AS + SP: Guilin

Injectables

- AS (30/60/120mg)powder for inj: GuilinSP + 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

black:

WHO prequalified + GF list

green: on GF list onlybold: single-source

supplies

new since mid

2015Slide10

Thank you very much

for

your attentionSlide11

Backup slidesSlide12

WHO prequalified malaria RDTs