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This guideline provides advice in regards to applications for Marketing Authorisations for antimicrobial veterinary medicinal products (VMPs) on the data required and the methodology to be used for performing an assessment of the risk to public health from antimicrobial resistance (AMR) due to use o
...
f the product. The scope of the guidance extends to VMPs intended for food producing species and to the transmission of AMR by the foodborne route or through direct contact with treated animals.
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Guidance for the preparation and submission of dossiers
An overview of COVID-19 Vaccine AstraZeneca and why it is authorised in the EU. Available in 22 languages
18 Febr. 2021
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 infected 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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First edition, November 1997 | Revised July 2002
PMPB/INS-GUIDE/01
Standards for Prosthetics and Orthotics Service Provision. 2015-2017 work plan
Department of Essential Medicines and Health Products (EMP) and NVI
World Health Organisation (WHO); USAID; ISPO
(2015)
C_WHO
Every day, fake medicines and medical products are sold at street corners, in open air markets or on unregulated websites in several countries in the African Region. These poor quality, unsafe medicines
...
and pharmaceutical products promote drug resistance and lead to loss of confidence in health professionals, manufacturers and distributors and in health systems. In an effort to protect people’s health, the WHO Regional Director for Africa, Dr Matshidiso Moeti, has proposed a strategy aimed at strengthening National Medicine Regulatory Authorities (NMRAs) in order to ensure that only safe, good quality and effective medical products are available.
more
This Indicator-Based Pharmacovigilance Assessment Tool (IPAT) was developed as a comprehensive performance metric for pharmacovigilance and medicine safety systems.
The purpose of these guidelines is to help health workers to participate in the process of continuous surveillance of safety and efficacy of the pharmaceutical products which are used in clinical practice, thus help to achieve the ultimate goal to m
...
ake safer and more effective treatment available to patients. This guideline addresses specifically the issues on what to report, why to report, when to report, where to report and how to report.
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The WHO Pharmaceuticals Newsletter provides you with the latest information on the safety of medicinal products and regulatory actions taken by authorities around the world.
In addition, this edition includes summary and recommendations from the vi
...
rtual meeting of the members of the WHO Programme for International Drug Monitoring (PIDM) and other partners, which was held on 20 October 2022.
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This handbook presents basic content and tips for implementing a school-based risk reduction programme. It is organised into five modules: its importance; approach and process; activities to benefit children up to five years old; activities for students aged 5–17; and activities for young people a
...
nd volunteers aged 17–24.
A generic framework for school-based risk reduction initiatives is illustrated in a diagram on p.10. The Comprehensive School Safety framework suggests a series of continuing activities that include: identifying the hazards in and around a school; conducting drills; preparing contingency and disaster management plans by involving parents, teachers and students; and building on the capacities of an institution and individuals to cope with the challenges during an unforeseen event. It also consists of three pillars: safe learning facilities; school disaster management; and risk reduction and resilience education. more
A generic framework for school-based risk reduction initiatives is illustrated in a diagram on p.10. The Comprehensive School Safety framework suggests a series of continuing activities that include: identifying the hazards in and around a school; conducting drills; preparing contingency and disaster management plans by involving parents, teachers and students; and building on the capacities of an institution and individuals to cope with the challenges during an unforeseen event. It also consists of three pillars: safe learning facilities; school disaster management; and risk reduction and resilience education. more
In preparing this paper, the Pharmacovigilance Group of the Pan American Health Organization’s Pan American Network for Drug Regulatory Harmonization (PANDRH) adopted the perspective of PAHO/WHO, which considers Pharmacovigilance, an essential component of public health programs. Its intention was
...
to facilitate the development of pharmacovigilance systems in the Region of the Americas and improve, strengthen, and promote the adoption of good practices to improve safety for patients and the general population, based on the needs of the Region.
Document also available in Spanish and Portuguese!
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with recommended essential medicines for common diseases in patients in Stockholm County Council (Healthcare Region), Sweden
