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Revision Bulletin ESPNF
Capacity Needs Assessment for Pharmaceutical Services for the ART Program in Lesotho
Wang, S., N. Hoohlo, I. Tshabalala, K. Ntoi, and T. Sepetla
Arlington, VA: Management Sciences for Health
(2013)
C2
Submitted to the US Agency for International Development by the Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program.
This document introduces four strategic objectives and twelve operational principles for good pharmaceutical procurement. These objectives and principles have been developed and endorsed by the Interagency
...
Pharmaceutical Coordination Group (IPC), involving the pharmaceutical advisers of the United Nations Children’s Fund (UNICEF), the United Nations Population Fund (UNFPA), the World Health Organization (WHO) and the World Bank. The aim of this document is to improve pharmaceutical procurement practices.
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In the mid-1980s, recognizing the limitations of traditional training and that the knowledge and skills acquired are not necessarily applied back in the workplace, MSH developed the Monitoring‐Training-Planning (MTP) approach to assist the Ecuadorian Ministry of Health to implement its Child Survi
...
val Program. Using the MTP approach, staff me
mbers learn to mobilize their own resources and to improve, incrementally, the management of medicines and other pharmaceuticals at their own facility.
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Licensed pharmaceutical products (marketing authorization) should be manufactured only by licensed manufacturers (holders of a manufacturing authorization) whose activities are regularly inspected by competent national authorities. This guide to GMP
...
shall be used as a standard to justify GMP status, which constitutes one of the elements of the WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce, through the assessment of applications for manufacturing authorizations and as a basis for the inspection of manufacturing facilities. It may also be used as training material for government medicines inspectors, as well as for production, QC and QA personnel in the industry
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This report, published in conjunction with a summary overview of results of rounds 1–8, is the eighth and final report in a series of laboratory-based evaluations of rapid diagnostic tests (RDTs) for malaria. It provides a comparative measure of their pe
...
rformance in a standardized way to distinguish between well and poorly performing tests.
These results constitute the laboratory evaluation component of the WHO prequalification process for malaria RDTs and inform the current WHO procurement recommendations. In round 8, 35 RDTs from 17 manufacturers were assessed. For the first time the evaluation included an assessment of product performance against a panel of P. falciparum parasites with pfhrp2/3 gene deletions and therefore not expressing HRP2.
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This guideline is intended to provide requirements to applicants wishing to submit
applications for registration of medicines in Botswana.
Rwanda Guidelines for variation to registered pharmaceutical products.
These guidelines have been developed to provide guidance to the Ministry of Health in managing applications for registration of human pharmaceutical products in Rwanda. It was compiled by the Technical Working Group (TWG) on Medicines Evaluation and
...
Registration (MER) of the East African Community Medicine Regulatory Harmonization (EAC MRH) Project. The group relied on their experiences and knowledge on medicines registration requirements of their individual Countries. World Health Organization (WHO) and the International Conference on Harmonization of Technical Requirements of Medicines for Human Use (ICH) and other available literature.
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