Approval Mechanism for Suppliers of Malaria Drugs and Nets

1
Approval Mechanism for Suppliers of Malaria Drugs
and Nets

• Presentation by Dr Maryse DuguéRBM Partnership
  Secretariat, Malaria Medicines Supplies
  ServicesCopenhagen 310 January 2006

10.2
2
Mechanisms

• 2 different mechanisms
• Prequalification for drugs
• WHOPES testing of pesticides for public health

3
Pre-qualification of Drugs Manufacturers
Products

• Issues a considerable number of sub-standard
  products and counterfeit anti-malarials
• 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

4
Pre-qualification of Drugs Manufacturers
Products

• Expression of Interest (EOI) - Artemisinin-based
  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)

5
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 ...

6
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 (letterfiles)
• Screening, assessing, and reviewing dossiers
• ? Report

7
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.

8
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

9
Issues with Prequalification of anti-malarials

• Status
• so far only one combination prequalified
  artemether/lumefantrine (Novartis)
• Several good candidates for artesunateamodiaquine
  
• Need additional mechanism to make good quality
  formulations available to countries joint
  tender WHO/UNICEF

10
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

11
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

12
Quality control of nets

• Specifications have been developed only for
  polyester netting's and Olyset
• LLINs resist more than 50 ISO normalized washes
  at 60C
• Additional work on specifications ongoing
  (meeting in December 2005)
• Provisional QC procedure available

13
WHOPES testing/evaluation of long-lasting
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
14
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 [phone]
• E-mail duguem_at_who.int