An approach to emergency situations. Relief workers face rapidly changing and complex environments, new disease patterns, enormous humanitarian needs and relatively limited resources. The authors of this book use their experience in the area to produce an operational manual of the issues involved in... refugee health programs. This book is aimed at professionals involved in public health assistance to refugees and displaced persons. It deals with a variety of specific refugee health issues at the decisional level, and discusses the priorities of intervention during the different phases of a refugee crisis, from emergency to repatriation.
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The manufacturing process is one of the key steps where quality control is required to ensure quality of medicinal products, including herbal medicines. Good manufacturing practices (GMP) is one of the most important tools for this measure.
There is an urgent need for safer, simpler, more efficacious and accessible treatment regimens for all forms of TB. The development of Target Product Profiles for TB treatment regimens (referred to as Target Regimen Profiles or TRPs) seeks to guide the drug development process towards important regi...men characteristics corresponding to the needs of end-users.
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The document introduces a simple classification, minimums standards and a registration form for Foreign Medical Teams (FMTs) that may provide surgical and trauma care arriving within the aftermath of a sudden onset disaster. These can serve as tools to improve the coordination of the foreign medical... team response, and be the reference for registration on arrival as well as a possible global registration mechanism similar to what exists for urban search and rescue teams
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These guidelines have been developed for scientific purpose with the main aim to guide the regulatory authority for evaluating probiotic products in our country.
The guidelines reiterate that the general principles of ethics for biomedical research involving human participants shall also be applicable. In addition, the guidelines specify unique provisions for stem cells, because of their inherent property for unlimited proliferation, differentiation to cells... of the germ layers, oncogenic potential, unrecognised toxicities and possible involvement in pre-implantation stages of human development. The guideline therefore focuses on: 1. Monitoring mechanism and regulatory pathway for basic, clinical research and product development based on categories of research and level of manipulation. 2. Procurement of gametes, embryos and somatic cells for derivation and propagation of any stem cell lines, their banking and distribution. 3. Other important areas like international collaboration, exchange of cell/lines and education for stakeholders and advertisement.
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The survey aimed at evaluating the quality of selected antimalarials in six countries of sub-Saharan Africa (Cameroon, Ethiopia, Ghana, Kenya, Nigeria and the United Republic of Tanzania). These countries have been supported by WHO to strengthen their regulatory controls o...ver antimalarial products. The survey was organized independently of manufacturers of antimalarial medicines.
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A resource for pesticide registrars and regulators.
The WHO urged governments to restrict access to highly toxic pesticides used for self-poisoning . Other effective interventions include education, youth intervention programs and follow-up of people at risk—and better data. Only 80 out of 183 WH...O member states reported high-quality vital registration data in 2016
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The MSF qualification scheme is concerned with the pharmaceutical quality assessment for drugs. This procedure is applicable to products for international supply, i.e. products supplied through the MSF procurement centres. This qualification procedure is not applicable for local purchase, i.e. purch...ase of drugs within the project countries. For quality assurance principles and assessment of drugs for local purchase refer to the guideline for local pharmaceutical market assessment.
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The purpose of adding the books to the website of MCAI for download, is to make this life-saving, up-to-date information available to all who need it. Fill in a short registration field and you can download the pdf-files.
If you work in a hospital in a low income country - providing free care - y...ou are probably intitled to FREE copies of these books. MCAI will send them to you, all you have to do is to read our Flyer and fill in the request form.
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Session V: Regulatory & quality assurance aspects
Update on prequalification of ARVs and regional harmonisation of medicine registration
Deusdedit K. Mubangizi
Group Lead, Inspections, WHO-PQT E-mail: mubangizid@who.int
Acknowledgements:
• Matthias Stahl
• Milan Smid
• Antony Fake
...• Jacqueline Sawyer
• Iveta Streipa
D-Building – UNAIDS
Kofi A. Annan Meeting Room
Wednesday, 9 March 2016 11:15 – 11:30
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The main objectives of these guidelines are to:
1. contribute to the quality assurance of medicinal plant materials used as the source for herbal medicines to improve the quality, safety and efficacy of finished herbal products;
2. guide the formulation of national and/or regional GACP guideli...nes and GACP monographs for medicinal plants and related standard operating procedures; and
3. encourage and support the sustainable cultivation and collection of medicinal plants of good quality in ways that respect and support the conservation of medicinal plants and the environment in general.
These guidelines concern the cultivation and collection of medicinal plants and include certain post-harvest operations.
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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 make 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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Medicines and Allied Substances [No. 3 of 2013 47 | An Act to continue the existence of the Pharmaceutical Regulatory Authority and re-name it as the Zambia Medicines Regulatory Authority; provide for the functions and powers of the Authority; provide for the registration and regulation of pharmacie...s, health shops and agro-veterinary shops; provide for the registration and regulation of medicines and allied substances; provide for the regulation of the manufacture, importation, exportation, possession, storage, distribution, supply, promotion, advertising, sale and use of medicines and allied substances; provide for the regulation and control of clinical trials; repeal and replace the Pharmaceutical Act, 2004; and provide for matters connected with, or incidental to, the foregoing.
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Communication to Healthcare Professionals Mar-2020
This guideline is intended to assist healthcare professionals in the participation of very important process of continuous surveillance of safety and efficacy of the health products which are used in their clinical practice. Continuous evaluation o...f medicines’ benefit and harm help to achieve the ultimate goal of safe and effective treatments available to patients.
The guideline is intended to assist healthcare professionals in the reporting of suspected adverse drug reactions (ADRs) associated with the use of all registered health products, including medicines, old medicines, medical devices and in-vitro diagnostics (IVDs).
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Actualmente, en el mundo, el cáncer produce millones de muertes al año, generando altos costos económicos y sociales, tanto por los valores asignados al tratamiento, como por el compromiso que genera en la productividad laboral de las personas directamente afectadas y de su entorno familiar y/o c...uidadores.
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The Practical manual on laboratory strengthening, 2022 update provides practical guidance on implementation of WHO recommendations and best practices for TB laboratory strengthening. It is an updated version of the GLI Practical Guide to Laboratory Strengthening published in 2017 and provides the la...test practical guidance on use of newly recommended diagnostics as well as guidance in key technical areas, including quality assurance and quality management systems, specimen collection and registration, procurement and supply-chain management, diagnostic connectivity, biosafety, data management, human resources, strategic planning, and model algorithms. The key changes are:
inclusion of recent or updated WHO recommendations for tests to diagnose TB and detect drug resistance;
alignment with the latest WHO critical concentrations for phenotypic drug-susceptibility testing (DST) and the new definitions of pre-XDR-TB and XDR-TB;
updated information on building quality-assured TB testing and management capacity using the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) approach (Score-TB package1);
updated information on assessing, analysing and optimising TB diagnostic networks; and
updated information on the use of next-generation sequencing (NGS) to detect mutations associated with drug resistance for surveillance purposes.
The document also provides references to resources and tools relevant for work on laboratory strengthening.
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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 virtual meeting of the members of the WHO Programme f...or International Drug Monitoring (PIDM) and other partners, which was held on 20 October 2022.
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More than 700 000 people lose their life to suicide every year. A core foundation of suicide prevention is the timely registration and regular monitoring of suicide and self-harm. Surveillance data can be used to show important progress towards reaching global targets, such as reducing the suicide r...ate by one third by 2030 as articulated in the UN SDGs and in the WHO Mental Health Action Plan 2013-2030. However, there are considerable discrepancies in the quality of data on suicide and self-harm globally. The aim of this training manual is to equip fieldworkers and supervisors with the skills to collect and manage data on suicide and self-harm in the community via key informants, health-care facilities and police records. In doing so, the value and overall goal is to strengthen the surveillance of suicide and self-harm in communities, particularly in LMICs and hard-to-reach communities where CRVS systems are weak or absent.
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This volume contains monographs prepared at the ninety-first meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA), which met virtually online from 1 to 12 February 2021.
The detailed monographs in this volume summarize data on specific contaminants in food. Individual monographs ...present the assessment of exposure to cadmium from all food sources, the technical, analytical, dietary exposure and toxicological data on ergot alkaloids, an assessment of five substances that may occur as previous cargoes, and a revision of the specifications for steviol glycosides. This volume and others in the WHO Food Additives series contain information that is useful to those who produce and use food additives and veterinary drugs and those involved with controlling contaminants in food, government and food regulatory officers, industrial testing laboratories, toxicological laboratories and universities.
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