PEPFAR's annual planning process is done either at the country (COP) or regional level (ROP).
PEPFAR's programs are implemented through implementing partners who apply for funding based on PEPFAR's published Requests for Applications.
Since 2010, PEPFAR COPs have grouped implementing partners according to an organizational type. We have retroactively applied these classifications to earlier years in the database as well.
Also called "Strategic Areas", these are general areas of HIV programming. Each program area has several corresponding budget codes.
Specific areas of HIV programming. Budget Codes are the lowest level of spending data available.
Expenditure Program Areas track general areas of PEPFAR expenditure.
Expenditure Sub-Program Areas track more specific PEPFAR expenditures.
Object classes provide highly specific ways that implementing partners are spending PEPFAR funds on programming.
Cross-cutting attributions are areas of PEPFAR programming that contribute across several program areas. They contain limited indicative information related to aspects such as human resources, health infrastructure, or key populations programming. However, they represent only a small proportion of the total funds that PEPFAR allocates through the COP process. Additionally, they have changed significantly over the years. As such, analysis and interpretation of these data should be approached carefully. Learn more
Beneficiary Expenditure data identify how PEPFAR programming is targeted at reaching different populations.
Sub-Beneficiary Expenditure data highlight more specific populations targeted for HIV prevention and treatment interventions.
PEPFAR sets targets using the Monitoring, Evaluation, and Reporting (MER) System - documentation for which can be found on PEPFAR's website at https://www.pepfar.gov/reports/guidance/. As with most data on this website, the targets here have been extracted from the COP documents. Targets are for the fiscal year following each COP year, such that selecting 2016 will access targets for FY2017. This feature is currently experimental and should be used for exploratory purposes only at present.
Promoting Quality of Medicines mandate is to help assure the quality and safety of priority medicines by strengthening medicines quality assurance mechanisms in developing countries. PQM is USAIDs response to the growing challenge posed by substandard and counterfeit medicines. These medicines can cause treatment failure and costly adverse events, increase morbidity and mortality, and potentially contribute to the more rapid emergence and spread of antimicrobial resistance. In addition to representing a significant public health threat, these medicines also risk undermining past and current health investments.
The availability of safe, quality and efficacious medicines in Nigeria continues to be challenge due the varying level of quality assurance standards among the local pharmaceutical industries and the quality of certification standards at Nigerias drug regulatory authority-National Agency for Food, Drug Administration and Control (NAFDAC) for both locally produced and imported medicines. Presently none of the Pharmaceutical Companies in Nigeria has attained World Health Organization (WHO) pre-qualification.
The USG will through this initiative improve compliance of selected manufacturers with Good Manufacturing Practices (GMP) and support the manufacturers in dossier preparation for WHO prequalification or other recognized prequalification systems, furthermore, the USG will through this partner be strengthening national medicines quality control laboratories at NAFDAC, this will address quality-assurance related aspects of drug registration and licensing.
The proposed budget will be utilized for the following health system strengthening activities:
a) Conduct initial Quality Assurance/GMP Pre- assessment of Select opportunistic infection (OI)Medicines Manufacturers. Develop an Expression of Interest (EoI) document with select criteria for selecting companies to benefit from PQM technical assistance .Conduct Review of Responses from manufacturers and verify through site audits. Assess selected companies( three)capabilities and potential and identify gaps regarding compliance with WHO GMP
b) Provide targeted technical assistance to obtain WHO GMP compliance of facility and manufacturing processes. Assist selected companies to obtain WHO GMP compliance for manufacturing site. This includes 1. Conduct 2-3 visits at various stages of GMP compliance 2.Work with manufacturers to develop process validation procedures, equipment calibrations and develop SOPs. 3. Produce reports and recommendations 4. Follow up on recommendationsc) Assist Selected Manufacturers in dossier preparation and submission to WHO and other Procurement Agencies. This includes evaluation of Active Pharmaceutical Ingredient(API) sources, and evaluation of NAFDAC's requirements for registration dossiers
d) Conduct quality control testing of manufactured OI medicines from the three manufacturers
e) Strengthen the Nigerian National Agency on Food and Drug Administration and Control and facilitate the registration of OI medicines. Conduct targeted assessment of Nigeria NAFDAC registration capabilities and dossiers reviews for OI product and provide assistance. Establish improved registration system and establish post market surveillance of the quality of OI medicine.
