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First Revised Edition
March 2000
DRUGS REGULATORY UNIT | NOVEMBER 2009 | SECOND EDITION
Therapeutics Information and Pharmacovigilance Centre | TIPC
This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of medicines. It represents the Medicines Control Council’s current thinking on the safety, quality and efficacy of medicines.
Made under Section 5 (c) of the Tanzania Food, Drugs and Cosmetics Act, 2003 | Second Edition
Guidelines for Handling Temperature Sensitive Vaccines and Pharmaceuticals
Health Evidence Network synthesis report 53
Selection and Use of Essential Medicines 2021
recommended
The 23rd meeting of the WHO Expert Committee on Selection and Use of Essential Medicines was coordinated from Geneva, Switzerland, and held virtually from 21 June to 2 July 2021. The Committee considered 88 applications proposing additions, changes and deletions of medicines, medicine classes and fo
...
Towards a world free of tuberculosis
Trials (2017) 18:152, DOI 10.1186/s13063-017-1881-z
Int J Vaccines Vaccin 2016, 2(1): 00018, January 29, 2016
Interferon-γ Assays - Description and Assessment of a New Tool in the Diagnosis of Tuberculosis.
Haür B et al. Interferon-γ-Tests in der ...Pneumologie 2006; 60: 29-44
Eine Leitlinie zur Diagnostik und Therapie, einschließlich Chemoprävention und -prophylaxe des Deutschen Zentralkomitees zur Bekämpfung der Tuberkulose e.V. im Auftrag der Deutschen Gesellschaft für Pneumologie und Beatmungsmedizin e.V.
Tuberculosis Guideline for Adults
Guideline for Diagnosis
...
Handbook of HUMANITARIAN HEALTH CARE LOGISTICS Designing the Supply Network and Managing the Flows of Information and Health Care Goods in Humanitarian Assistance during Complex Political Emergencies
Pan African Medical Journal 2017;27:215. doi: 10.11604/pamj.2017.27.215.12994
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
...
These guidelines for the National Pharmacovigilance and Medicine Information System in Rwanda have been developed to ensure that safe, efficacious and quality medicines are made available to all Rwandans.
The current SEARVAP (South-East Asia regional vaccine action plan) describes a set of regional goals and objectives for immunization and control of vaccine-preventable diseases for 2016 – 2020 and highlights priority actions, targets and indicators that address the specific needs and challenges of
...
Vitamin D deficiency is thought to be common among pregnant women, particularly during the winter months, and has been found to be associated with an increased risk of pre-eclampsia, gestational diabetes mellitus, preterm birth, and other tissue-specific conditions.
This guideline is intended for
...
Guideline
Iron deficiency is one of the most common forms of nutritional deficiencies, particularly among vulnerable groups such as women, children and low-income populations. Iron deficiency often precedes anaemia, and anaemia during pregnancy is one of the strongest predictors of anaemia duri ...
Iron deficiency is one of the most common forms of nutritional deficiencies, particularly among vulnerable groups such as women, children and low-income populations. Iron deficiency often precedes anaemia, and anaemia during pregnancy is one of the strongest predictors of anaemia duri ...
Effective malaria prevention is threatened by widespread and increasing vector insecticide resistance. Failure to mitigate this threat will likely result in an increased burden of disease, with significant cost implications. This new framework provides support for the development of a national insec
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An estimated 59 000 people die from rabies each year. That’s one person every nine minutes of every day, 40% of whom are children living in Asia and Africa. As dog bites cause almost all human cases, we can prevent rabies deaths by increasing awareness, vaccinating dogs to prevent the disease at i
...
The objectives of these guidelines are to provide recommendations outlining a public health approach to managing people presenting with advanced HIV disease, and to provide guidance on the timing of initiation of antiretroviral therapy (ART) for all people living with HIV.
WHO recommends that a ...
WHO recommends that a ...
The National Strategic Plan for HIV/AIDS and STIs 2017-2024 spells out the objectives and targets that we have jointly committed to achieve. The plan describes the strategies and activities that will need to be implemented on the ground across India's 36 States and Union Territories with the help of
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This document provides a systematic approach in developing a coordinated, standardized, reliable, efficient, cost-effective, and sustainable specimen transport and referral system to support IVHD and VL testing networks. This document provides technical and programmatic recommendations on the approp
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Translation of the 1st ed., 2003
These guidelines were written for anyone trying to meet and solve the challenges of operating a warehouse today. They are an important reference tool for managers and staff, whether they are constructing a new warehouse, implementing a new warehouse syste ...
These guidelines were written for anyone trying to meet and solve the challenges of operating a warehouse today. They are an important reference tool for managers and staff, whether they are constructing a new warehouse, implementing a new warehouse syste ...
Journal of The Association of Physicians of India, Vol. 63 November 2015,, pp.77-96
WHO TRS N°1012.
Key updates include: (i) surveillance strategies, including cross-sectoral linking of systems and suitable diagnostics; (ii) the latest recommendations on human and animal immunization; (iii) palliative care in lowresource settings; (iv) risk assessment to guide management of bite
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These guidelines have been developed specifically to address ethical issues of conducting research in children.
The new guidelines provide public health guidance on pharmacological agents for managing hyperglycaemia in type 1 and type 2 diabetes for use in primary health-care in low-resource settings. These guidelines update the recommendations for managing hyperglycaemia in the WHO Package of Essential NCD I
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From raising awareness to building capacity
Meeting Report
World Health Organization, Geneva, Switzerland 16 -18 September 2013
Report of the 23rd WHO Expert Committee on the selection and use of essential medicines
This executive summary reports the recommendations made by the Expert Committee for the 2021 update of the WHO Model List of Essential Medicines (EML) and the Model List of Essential Medicine for Children (EMLc)
...
PQDx 0018-010-00 WHO
PQDx PR
July/2016, version 3.0
In recognition of the growing problem of antimicrobial resistance (AMR), its increasing threat to human, animal and plant health, and the need for a One Health approach to address this issue, the 39th Session of the Codex Alimentarius Commission (CAC) agreed it was important for the food safety comm
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This situation analysis has gathered information about the current state of AMR, contributing factors and antimicrobial use in Zimbabwe from the human, animal, agricultural and environmental sectors. Data has been gathered from different sectors such as the general public, academia, the Ministry of
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Sepsis contributes significantly to preventable mortality and is the final common pathway to death for severe infectious diseases; it can also arise as a complication of injuries and non-communicable diseases.
The Pharmacovigilance team in WHO aims to assure the safety of medicines and vaccines by ensuring reliable and timely exchange of information on safety issues, promoting pharmacovigilance activities throughout the Organization and encouraging participation in the WHO Programme for International Drug
...
The Bolivarian Republic of Venezuela has been facing a sociopolitical and economic situation that has negatively impacted social and health indicators. There have been intensified population movements both within the country and to other countries, particularly to Argentina, Brazil, Chile, Colombia,
...
WHO‘s Global Strategy to Accelerate the Elimination of Cervical Cancer, launched today, outlines three key steps: vaccination, screening and treatment. Successful implementation of all three could reduce more than 40% of new cases of the disease and 5 million related deaths by 2050.
14 January 2021
This practical guide can be used to help countries monitor and analyse the impact of COVID-19 on essential health services to inform planning and decision-making. It provides practical recommendations on how to use key performance indicators to analyse changes in access to and deliv
...
22 December 2020
The COVID-19 vaccine safety guidance manual has been developed upon recommendation and guidance of GACVS members, as well as by experts incorporating current and available information critical to all stakeholders when COVID-19 vaccines will be introduced.
For ease of use, the man
...
It will be updated continuously.
Details of COVID-19 availability in all ten ASEAN countries and another 30 Asian nations.
Due to the developing situation in China and Asia concerning the Coronavirus, we will be operating this article as a running live update service to keep businesses involved in
...
Fair global distribution of COVID-19 vaccines
recommended
MEDBOX Issue Brief no.9 ,1 Febr. 2021
The purpose of this field guide is to provide comprehensive information on planning and implementing high-quality3 SIAs for injectable vaccines and highlight the opportunities to strengthen RI and surveillance. The guide uses measles–rubella SIAs as the main example throughout, but the informatio
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An Action Framework and annexe to Immunization Agenda 2030 (Draft version)
27 January 2021
National Essential Diagnostic List
recommended
A WHO-UNICEF joint statement encouraging greater health commodity supply chain integration for temperature-sensitive pharmaceuticals where appropriate, 19 November 2020
The procurement of essential medicines and other health products is a critical function in support of the effective discharge of WHO’s mandate, and WHO values the importance of the quality of essential medicines and health products that are supplied to countries. The first World Health Assembly in
...
The objective of this project was to list the medical devices required to provide the essential reproductive, maternal, newborn and child health interventions defined by existing WHO guidelines and publications, in order to improve access to these devices in low- and middle-income countries, support
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Pharmaceutical regulators are at the forefront of ensuring that only safe and effective medicines are authorized and available in the market. This document builds on the recommendations in the above publication and has been prepared to specifically assist national medicines regulatory authorities to
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Enabling young children to achieve their full developmental potential is a human right and an essential requisite for sustainable development. Given the critical importance of enabling children to make the best start in life, the health sector, among other sectors, has an important role and responsi
...
Objetivos.
Estimar la carga de tuberculosis (TB) en menores de 15 años y describir las características clínico, epidemiológicas y los resultados del tratamiento antituberculoso en Ecuador.
Métodos.
Se realizó un estudio retrospectivo utilizando los datos del programa nacional de TB de los
...
Validation of elimination of mother-to-child transmission, or vertical transmission, of HIV, syphilis and hepatitis B virus (HBV), is an attestation that a country has successfully met standard criteria for elimination, or for being at 1 of the 3 levels of achievement on the ‘Path to Elimination
...
WHO/UNICEF/UNFPA joint statement
WHO/UNICEF/UNFPA joint statement
This companion document to Ending the neglect to attain the Sustainable Development Goals: a road map for neglected tropical diseases 2021-2030 ("the road map") aims to support a range of stakeholders - including countries in which neglected tropical diseases (NTDs) are endemic, international organi
...
Strategic Plan for COVID-19 vaccination in Argentina
The OIE has been working on the AMR issue for a long
time. In undertaking its role as a standard- setting organisation*
for animal health, including zoonoses, the OIE has developed
a wide range of international standards on antimicrobial
agents, in particular on responsible and prudent use.
The
...
The roadmap describes the actions needed to
achieve the three development goals for TB
vaccines set by the WHO:
1. A safe, effective and affordable TB vaccine
for adolescents and adults.
2. An affordable TB vaccine for neonates and
infants with improved safety and efficacy.
3. A therapeutic v
...
(Last Update: July 2022)
Malaria vaccine: WHO position paper - March 2022
recommended
Weekly Epidemiological Record No 9, 2022, 97, 61–80
This position paper supersedes the 2016 publication, “Malaria vaccine: WHO position paper-2016.”1 It includes the updated WHO recommendations on the wider use of the RTS,S/AS01 vaccine for the reduction of malaria morbidity and mortality in
...
The marathon to eradicate polio is on its final lap: the world is more than 99% of the way to success. After millennia of living with poliovirus and suffering the paralysis it causes, today nearly all the world’s people live in polio-free countries; two of the three strains of wild poliovirus (WPV
...
The goal of the global outbreak response for monkeypox is to stop human-to-human transmission of monkeypox, with a priority focus on communities at high risk of exposure which may differ according to context, and to effectively use strong public health measures to prevent onward spread of the diseas
...
Tools and practical guidance for achieving high uptake
The report aims to capture lessons from the COVID-19 pandemic and to highlight the opportunity for more ambitious global action: expanding sustainable access to vaccines for all towards
the Immunization Agenda 2030 and pandemic prevention, preparedness and response efforts. The report is organized
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Pharmaceutical News
Evaluation of Saccharide Content of the WHO 2nd International Standard for Haemophilus Influenzae Polysaccharide Polyribosyl Ribitol Phosphate (PRP) by HPAECPAD Analysis Following Acid Hydrolysis
Consultation Documents
Lamivudine and tenofovir disoproxil fumarate tablets (lami
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Driving progress towards rabies elimination: Results of Gavi’s Learning Agenda on rabies and new WHO position on rabies immunization
The Pandemic Influenza Pandemic (PIP) Framework's Partnership Contribution (PC) High-Level Implementation Plan III (HLIP III) outlines the strategy for strengthening global pandemic influenza preparedness from 2024 to 2030. HLIP III takes into consideration the lessons learned from the response to t
...
The World Health Organization (WHO) is releasing the second edition of its Global Accelerated Action for the Health of Adolescents (AA-HA!) guidance. The document aims to equip governments to respond to the health and well-being challenges, opportunities and needs of adolescents.
The guidance pro
...
Building on the 2021 Interim guidance, this second version and update, incorporates the lessons and feedback from the hepatitis pilots that successfully demonstrated the feasibility of measuring hepatitis B and C impact targets to demonstrate elimination, whilst highlighting challenges caused by hig
...
This publication aims to provide updated guidance on the specific use of yellow fever laboratory assays in the context of surveillance to be used across the Global Yellow Fever Laboratory Network for disease surveillance. In the recent years, new commercial assays became available and are now recomm
...
To survive and thrive, children and adolescents need good health, adequate nutrition, security, safety and a supportive clean environment, opportunities for early learning and education, responsive relationships and connectedness, and opportunities for personal autonomy and self-realization. To prom
...
Terminology used to describe the transmission of pathogens through the air varies across scientific disciplines, organizations and the general public. While this has been the case for decades, during the coronavirus disease (COVID-19) pandemic, the terms ‘airborne’, ‘airborne transmission’ a
...
The far-reaching impacts of the COVID-19 pandemic underscore the critical need for evidence-informed, transparent and inclusive decision-making. Policy-makers have grappled with complex choices amidst uncertainty. They have constantly reassessed response measures while navigating their economic impl
...
Introduction Pharmacovigilance (PV) systems to monitor drug and vaccine safety are often inadequate in sub-Saharan
Africa. In Malawi, a PV enhancement initiative was introduced to address major barriers to PV.
Objective The objective of this initiative was to improve reporting of adverse events (A
...
Adolescence is a critical stage in life for physical, cognitive and emotional development, shaping future health and well-being. Comprehensive measurement of adolescent health is essential to prioritize health issues, guide interventions and track progress. However, global, regional and national ado
...
Bonchial asthma is the most common chronic respiratory disease in the world. In Kenya, it has been estimated that about 7.5% of the Kenyan population, nearly 4 million people, are currently living with asthma. Many cases tend to be underdiagnosed and undertreated which leads to high levels of morbid
...
Pneumonia and diarrhoea account for 23% of under-five mortality and were responsible for an estimated 1.17 million deaths in children under five globally. Furthermore, pneumonia and diarrhoea were responsible for 18% of mortality in children 5–9 years of age, resulting in an estimated 86 000 preve
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Long-term polio vaccine security – the timely, sustained, and uninterrupted supply of suitable types of affordable, quality-assured polio vaccines – is essential in the global effort to achieve and maintain a polio free world. However, fragmented approaches and short-term planning pose considera
...
