Policy on Quality Assurance for Single and Limited-Source Pharmaceuticals

1. Policy on Quality Assurance for Single and Limited-Source Pharmaceuticals Geneva 12-15 December 2005

2. Background The procurement policy of the GF specifies certain conditions under which the grant recipients can procure single or limited source pharmaceutical products *). Option A: Products pre-qualified by WHO (UN procurement quality and sourcing project) Option B: Products authorized for consumption by a stringent regulatory authority **) Option C: Products authorized by the NDRA of the Recipient country. Concern was raised that many recipient countries National Drug Regulatory Authorities (NDRA) may not have the technical capacity and resources to carry out the necessary quality assurance. *) Pharmaceutical products for which there are not publicly available quality assurance standards, analytical methods and reference standards **) An authority either belonging to the International Conference on Harmonization of Technical requirements of registration of pharmaceuticals for human use (ICH) or to the pharmaceutical Inspection Cooperation Scheme (PIC/S).

3. Decision to change the Policy During the 10th Board meeting in April 2005 the Board approved new and amended guidelines for the Policy on Quality Assurance for Single and Limited-Source Pharmaceuticals.

4. Option A: Products pre-qualified by WHO (UN procurement quality and sourcing project) Option A: The same Option B: Products authorized for consumption by a stringent regulatory authority Option B: The same Option C: Products authorized by the NDRA of the Recipient country. Option Ci: The manufacturer has submitted an application for pre-qualificationto the WHO or approval from a stringent regulatory authority and the manufacturing site is GMP compliant as certified by WHO or a stringent regulatory authority. Option Cii: The product is manufactured at a GMP compliant manufacturing site as certified by WHO or a stringent regulatory authority Policy changes Old Policy New Policy

5. If products unavailable, PR informs Secretariat and then: Has to procure from one of the (a) or (b) suppliers  2 manufacturers of equivalent products Number of Option (a) or (b) manufacturers producing equivalent products (i) The manufacturer has submitted an application to the WHO or a stringent regulatory authority and the manufacturing site is GMP compliant. IF NOT, THEN (ii) Manufactured in a GMP-compliant manufacturing facility  2 manufacturers of equivalent products * Product defined as: chemical + strength + formulation **Unavailability defined as: inability of the manufacturer to supply a sufficient quantity of finished product within 90 days from date of order. The PR is required to notify GF if procuring under (i) or (ii) Application

6. TGF Secretariat: TGF shall contract an independent 3rd party to conduct random quality analysis of products procured pursuant option Ci or Cii Obligations If products unavailable, PR informs Secretariat and then: Has to procure from one of the (a) or (b) suppliers  2 manufacturers of equivalent products Number of Option (a) or (b) manufacturers producing equivalent products Principal Recipients: Shall promptly notify the global fund in writing if it plans to procure any products pursuant option Ci or Cii Shall obtain documentation of the application and/or GMP compliance Shall permit access to storage sites and removal of samples (i) The manufacturer has submitted an application to the WHO or a stringent regulatory authority and the manufacturing site is GMP compliant. IF NOT, THEN (ii) Manufactured in a GMP-compliant manufacturing facility  2 manufacturers of equivalent products

7. Contracts entered before April 30, 2005 may be honoured until they expire or otherwise terminate. 1 2 3 4 After April 30, 2005, the Principal Recipient may not enter into any new contracts, nor extend any existing contracts, for the supply of products that would have qualified for purchase under the original Clause 3. If there are less than 2 suppliers according to Option (A) or (B), or if products from these suppliers are unavailable then Grant funds may be used to procure products according to Option Ci or Cii (In order of priority) PR shall revert to Option (A) or (B) as soon as products from 2 or more suppliers become available. Conditions

8. Development of a list of products found compliant with The Global Fund Policy on Quality Assurance. Short term implementation of interim quality control testing by an independent 3rd party. Initiated the development of a permanent solution to more comprehensive Quality Control Testing Key actions taken

9. A B C The Global Fund Compliance List • Key features of the compliance list: • Split by disease area (HIV – TB – Malaria) • Ordered according to the ingredient / generic name of the product • Information: • Product • Strength • Dosage form • GF classification (A, B, Ci or Cii) • Name of supplier • Approval authority (WHO or Regulatory authority) • Address of manufacturing site • Packaging type • Packaging size

10. The Global Fund Home page Procurement and Supply Management Quality Assurance Information Actual Compliance Lists HIV TB Malaria Compliance List – Front page The Global Fund Compliance List

11. The Global Fund Compliance List Follow this link: http://www.theglobalfund.org/en/about/procurement/quality/