PQDx 0197-045-00 WHO
PQDx PR
March /2016, version 2.0
PQDx 0141-051-00 WHO
PQDx Public Report
April/2017, version 5.0
Interim Assessement Report
The EMA review was started by the Agency’s Committee for Medicinal Products for Human Use (CHMP) to support decision-making by health authorities. This first interim report includes information on seven experimental medicines intended for the treatment of people infecte...d with the Ebola virus:
BCX4430 (Biocryst);
Brincidofovir (Chimerix);
Favipiravir (Fujifilm Corporation/Toyama);
TKM-100802 (Tekmira);
AVI-7537 (Sarepta);
ZMapp (Leafbio Inc.);
Anti-Ebola F(ab’)2 (Fab’entech).
The amount of information available for the seven treatments is highly variable. For some compounds there is no data from use in human subjects available. A small number of treatments have been administered to patients in the current Ebola outbreak as compassionate use. Finally, there are also medicines included in this review that have already been studied in humans, albeit for the treatment of other viral diseases.
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The scope of this PPC document is to serve as a guide to address the unmet public health need for a PPE system that protects the HW-F in tropical climate
s while caring for patients and providing heavy duty essential health services.
The characteristics described in this guidance are targeted fo...r PPE used in
health clinics, hospitals and communities in low resource settings where there is lack of advanced environmental controls and equipment. The purpose is to ensure harmonization in PPE design and its use to avoid confusion and exacerbating the risk of infections in HW-F. The principles of this PPC document can also be considered in risk reduction strategies
in other healthcare settings.
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Doc. No.: INS/GDL/001-(Annexes)
Public Report
PQMC 0001-001-04 WHO PQMC Public Report November/2016, version 8.0
Public Report
PQMC 0003-003-00 WHO PQMC PR June/2015, version 2.0
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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Soil-transmitted helminths are a group of intestinal worms that include Ascaris lumbricoides (giant roundworm), Trichuris trichiura (whipworm), and Ancylostoma spp. (A. duodenale, A. ceylanicum) and Necator americanus (hookworms). Despite the clear biological differences among the different species,... their transmission is characterized by the same sequence of events: (i) infected individuals excrete worm eggs through their stool in soil; (ii) under optimal conditions of moisture and temperature the excreted eggs develop into infectious stages; and (iii) finally, infection occurs through oral uptake (Ascaris, Ancylostoma and Trichuris) or skin penetration (Ancylostoma and Necator) of these infectious stages (embryonated eggs and third stage larvae) that reside in the soil and/or in the environment (referring to their common name).
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Drug Distribution and Control: Preparation and Handling–Guidelines
Review 2008
Drug Distribution and Control: Preparation and Handling
This Technical Assistance Bulletin is intended to assist pharmacists in the extemporaneous compounding of non-sterile drug products for individual patients. Included in this document is information on facilities and equipment, ingredient... selection, training, documentation and record keeping, stability and beyond-use dating, packaging and labeling, and limited batch compounding. This document is not intended for manufacturers or licensed repackagers.
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In order to streamline and effectively control compounding of medicinal products in hospitals and pharmacies, these Guidelines for Production of Extemporaneous and Hospital Based Sterile Preparations has been crafted. The purpose of these guidelines therefore is to assist pharmacists in ...discharging their legal and professional obligations to patients in the area of extemporaneous dispensing. This guidance will help to assure the safe and appropriate preparation and supply of extemporaneously prepared medicinal products to patients, where
the supply of such products is necessary.
Extemporaneous and hospital based sterile preparations are critical for patients whose clinical needs cannot be met by registered medicinal products. The guidelines outline the principles and application of the concepts of Good Manufacturing Practice (GMP) requirements for premises, equipment, personnel, storage, quality management system, quality control, compounding processes as well as documentation.
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This publication describes the first WHO public-benefit Target Product Profiles (TPPs) for snakebite antivenoms. It focuses on antivenoms for treatment of snakebite envenoming in sub-Saharan Africa. Four TPPs are described in the document:
Broad spectrum Pan-African polyvalent antivenoms: products ...that are intended for widespread utility throughout sub-Saharan Africa for treatment of envenoming irrespective of the species of snake causing a bite. Monovalent antivenoms for specific use cases: for products for a single species (or genus) of snake (e.g., boomslangs or carpet viper antivenoms).
Syndromic Pan-African polyvalent antivenoms for neurotoxic envenoming: products that are intended for treatment of envenoming by species whose venoms are neurotoxic. Syndromic Pan-African polyvalent antivenoms for non-neurotoxic envenoming: products for snakebite envenoming where the effects are largely haemorrhagic, necrotic or procoagulant.
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