UNFPA procures medicines that have been selected from the WHO Model List of Essential Medicines as well as National Essential Drugs Lists.
In consultation with WHO and other UN agencies, UNFPA has developed a Quality Assurance Policy for Reproductive Health Medicines. The suppliers of medicines procured by UNFPA must have a current Good Manufacturing Practice certification issued by an authority part of the the Pharmaceutical Inspection Co-operation Scheme, PIC/s, manufacturing licenses, national regulatory approval, and be qualified for procurement through the evaluation processes outlined in the Policy.
UNFPA Quality Assurance Policy
1) RH Medicines included in the WHO Expression of Interest for Prequalification of Medicines Programme.
- Prequalification Programme: UNFPA procures only, except for the special case below, RH medicines which have been approved by WHO through the WHO Prequalification programme or that have been authorized for use by a Stringent Regulatory Authority (SRA). More information of this programme, as well as the complete list of WHO Prequalified Medicines, can be obtained through the WHO website.
The ERP process has been developed as an interim mechanism in the cases when procurement of certain medicines is necessary and there are not enough RH Medicines available that are WHO prequalified or SRA approved. In those cases, and always prioritizing quality, UNFPA and WHO will assess the quality standards of the requesting manufacturers and will make a decision towards recommending or not the procurement of these medicines for a period of 18 months –subject to performance this time might be extended 12 more months-. This assessment mechanism is a temporary solution to undertake while suppliers undergo the WHO Prequalification Process.
A new Expression of Interest for the ERP process was published in May 2014.
ERP reviewed products can be found here.
For medicines under WHO EOI for RH medicines that do not appear on the ERP reviewed list, PSB may allow procurement in case there is any risk category 3 option provided a Notification form (found here) has been completed by the procurer and approved by QA.
2) Other Medicines
- Internal Technical Committee (ITC): The ITC is the UNFPA’s internal mechanism used for medicines not included in the Expression of Interest under the WHO Prequalification of Medicines Programme. In those cases UNFPA will risk assess the submissions and make a decision based on GMP compliance; quality assurance of Active Pharmaceutical Ingredients and the Finished Pharmaceutical Products; reference to the latest edition of British, United States, European or International Pharmacopoeias, stability data and safety and efficacy/therapeutic equivalence.