WHO with UNICEF and other UN partners is conducting a pre-qualification of suppliers (manufacturers) of HIV/AIDS, Tuberculosis and Malaria drugs. UNFPA has been designated the focal point for condoms and IUDs. Subset of WHO Pre Qualification of EDM Process is consistent with WHO / ISO Pre Qualification

Objectives Facilitate 3 core elements of UNFPA Global Strategy on RHCS i.e. – technical cooperation, –building national capacity and –improving sustainability Broaden the RH commodity supplier base – all geographical regions Widen the RH commodity supplier base to include generic sources. Increase supply volumes Reduce lead times for RH Commodity deliveries

Objectives (continued) Assure users of quality & safety of RH commodities Technical advice to manufacturers Enable government agencies and NGOs to undertake their own procurement of contraceptives and RH commodities in the future. System meets policy requirement of important donors and partners and can be utilized by all donors and clients.

Scope 1Condoms (M) Female Condom IUDs Male Latex Condoms Guidelines 2003 WHO/ISO Work on generation 2 Population Council /ISO specs– To be merged 2Pills Injectables Based on the various Pharmacopoeia International, British, American 3Safe Motherhood RH Kits, Oxytocin, Magnesium sulphate, misoprostol 4Capacity Building Equipment, training of laboratory personnel, laboratory inspection & certification

Condoms Desk Study - methods standards for prequalification Development of qualification profile Development of TOR’s for Technical Firms /Consultants Open invitation to Pre-qualify UN Development Total of 35 inspections completed in total Only16 manufacturers Approved/Pre-qualified 14 inspections scheduled (ongoing) UNFPA has been collaborating with PSI in this activity

Intra Uterine Devices ( IUDS) Desk Study - methods standards for prequalification Development of qualification profile, Development of TOR’s for Technical Firms /Consultants Open invitation to Pre-qualify UN Development October 16, Issue No inspections completed 6 approved 8 inspections pending UNFPA working with WHO and ISO on final IUD standards

Pills/Injectables WHO managing prequalification inspection activities under their Gates project. UNFPA Liaison with WHO UNFPA /PPD Conducted study on the preparedness of manufacturers to supply generic products UNFPA streamlined /improved procedures for contracting, pre shipment and post shipment inspections

Safe Motherhood Products Broaden supply base, increase access to quality essential safe motherhood drugs i.e oxytocin, magnesuim sulphate misoprotol Drugs that appear on the WHO Essential Drug List ( EDL) Desk Study on sources completed Paper on Prequalification of generic suppliers to be developed Aim: Not to lose sight of the fact that UNFPA is primarily a Population Agency

Capacity Building Assist Government Ministries of Health obtain –international accreditation for their testing laboratories, –provide training for laboratory personnel – equip existing laboratories. UNFPA working with USAID /FHI Merge activities related to capacity building Background /Strategy paper being developed Discussion meeting planned for end of June involving all interested partners

CONDOMS - Factory Audit & Inspection Managed by UNFPA CONDOMS - Factory Audit & Inspection Managed by UNFPA Reporting, dissemination of results (Long Term Agreements) Reporting, dissemination of results (Long Term Agreements) PILLS - Factory Audit & Inspection Managed by WHO PILLS - Factory Audit & Inspection Managed by WHO IUDS-Factory Audit & Inspection Managed by UNFPA IUDS-Factory Audit & Inspection Managed by UNFPA INJECTABLES - Factory Audit & Inspection Managed by WHO INJECTABLES - Factory Audit & Inspection Managed by WHO Capacity Building in UNFPA countries, Procurement of equipment, training of laboratory personnel, laboratory inspection & certification National Capacity Building (In-country inspection and testing etc.) PSS Implementation PSS Implementation TSD / CMB Funding, Monitoring & Evaluation TSD / CMB Funding, Monitoring & Evaluation Monitoring and Evaluation Pre-Qualification of Suppliers An Open Invitation to Pre-Qualify based on International procurement standards Verification of manufacturing processes & procedures, quality systems - The RHCS Capacity Building & Quality Assurance Process and Organisation SAFE MOTHERHOOD- Managed by UNFPA