Transcript Approval Mechanism for Suppliers of Malaria Drugs and Nets

Approval Mechanism for Suppliers
of Malaria Drugs and Nets
Presentation by Dr Maryse Dugué
RBM Partnership Secretariat, Malaria Medicines & Supplies Services
Copenhagen – 310 January 2006
10.2
Mechanisms
2 different mechanisms:
• Prequalification for drugs
• WHOPES testing of pesticides
for public health
Pre-qualification of Drugs
Manufacturers & Products
• Issues: a considerable number of substandard products and counterfeit antimalarials
• Objectives:
– To accelerate sustained access to, and use of,
good quality ACTs
– To ensure that adequate and effective treatment
reaches significantly greater numbers of people in
need
– To assist/support the implementation of ACTs in
ways that respond to the specific needs and
requests of individual countries
– To support drug regulatory agencies in regulating
ACTs
Pre-qualification of Drugs
Manufacturers & Products
• Expression of Interest (EOI) - Artemisininbased ACTs
– Products selected:
• Artesunate (oral preparations, rectal prep.)
• Dihydroartemisinin (tablets, capsules,
granules, suppositories)
• Artemether (oral preparations)
• Artemether/lumefantrine (oral preparations)
• Artesunate + amodiaquine (oral preparations)
• Artesunate + mefloquine (oral preparations)
• Artesunate (injection for IV and IM)
• Artemotil (injection forms)
• Artesunate + sulphadoxine/pyrimethamine
(oral preparations)
Multi-source combination antimalarial
drug products - in majority of cases not
typical “generic” drugs
• Usually generic drugs “well established” …
– ACTs are relatively new, or very new drugs
– Limited information available in public domain
• Most ACTs do not have quality standards
• For most ACTs reference standards not
readily available
– Reference standards available only for those that
have pharmacopoeial monographs
• Difficulties of proving “interchangeability”
• Regulators have limited experience with
this group of drugs ...
Pre-qualification of Drugs
Manufacturers & Products
• Processes of Pre-qualification of
manufacturers (of artemisinin-based
combination antimalarial drug products)
– Preparatory Phase
• Drafting of specifications and guidelines
(products and product files)
• Publication of Expression of Interest (EOI) IHT and WWW
– Documentation Review Phase
• Receiving of EOI (letter+files)
• Screening, assessing, and reviewing dossiers
 Report
………
Pre-qualification of Drugs
Manufacturers & Products
• Processes of Pre-qualification of
manufacturers (of artemisinin-based
combination antimalarial drug products)
– Plant Inspection (GMP compliance)
Phase
• Team of inspectors appointed by QSM/EDM
• Inspections carried out jointly with respective
DRA
– Reporting Phase
• Results in a “white” list of products and
manufacturers.
Pre-qualification of Drugs
Manufacturers & Products
• Assessment of dossiers
– Carried out by teams of professionals
from national DRAs (mix of developed
and developing countries)
• Manufacturing sites inspections
– Carried out by teams of three: WHO
representative (qualified GMP inspector),
inspector from well established
inspectorate (PIC/S countries) and
national inspector(s)
• Qualified inspectors pool limited,
no additional capacities
Issues with Prequalification
of anti-malarials
• Status:
so far only one combination prequalified:
artemether/lumefantrine (Novartis)
• Several good candidates for
artesunate+amodiaquine
Need additional mechanism to make
good quality formulations available
to countries: joint tender
WHO/UNICEF
Access to ACTs of Good Quality
• List of products/manufacturers evaluated
as complying with GMP and other quality
requirements
• Items included in the WHO WebBuy and
UNICEF Supply Division catalogue
• List available on MMSS website:
http://rbm.who.int/mmss/procurement.html
Insecticides Treated Nets
& quality assurance
WHOPES collects, consolidates, evaluates
and disseminates information on the use
of pesticides for public health. Its recommendations
facilitate the registration of pesticides by Member
States.
• WHOPES is NOT a registration authority
• But: a product IS or IS NOT regarded as a
LLIN after WHOPES evaluation
• PermaNet® 2.0 and Olyset Net® are
currently the only LLINs recommended by
WHO for malaria prevention and control
Quality control of nets
• Specifications have been developed only
for polyester netting's and Olyset
• LLINs: resist more than 50 ISO normalized
washes at 60°C
• Additional work on specifications ongoing
(meeting in December 2005)
• Provisional QC procedure available
WHOPES testing/evaluation of longlasting insecticidal mosquito nets
Phase
Type of Study
Activities
Phase I
Laboratory
•Regeneration of insecticide and
wash resistance
•Efficacy
Phase II
Small-scale
field trials
•Impact on vector behaviour
•Efficacy under different
ecological settings
•Safety observations
Phase III
Medium- and/or
large-scale field
trials
•Long-lasting efficacy
•Community acceptance
•Safety observations
How to contact us…
Malaria Medicines & Supply Services (MMSS)
Roll Back Malaria Partnership Secretariat
Website: http://rbm.who.int/mmss/
Dr Maryse Dugué
Manager
Tel: +41 (0)22 791 4439
E-mail: [email protected]