Filter
607
Text search:
pharmaceutical
regulatory
authority
Featured
52
198
Language
Document type
335
104
88
34
26
8
5
4
2
1
Countries
36
31
25
24
20
17
17
16
16
15
15
13
11
10
10
10
9
8
8
8
7
7
6
5
5
5
5
4
4
3
3
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
Authors & Publishers
Publication Years
Category
325
33
19
14
9
8
3
Toolboxes
88
81
30
23
22
19
17
9
6
6
6
5
4
3
3
3
2
2
1
1
To understand the national situation, Ethiopia did a situation assessment, launched its first strategy in 2011, and took action to contain AMR, as detailed in the blue boxes found throughout this strategy. This updated version of the strategy was in response to the revised health and medicines polic
...
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
Lamivud
...
DRUGS REGULATORY UNIT | NOVEMBER 2009 | SECOND EDITION
This interagency report provides recommendations for assuring quality of medicines during key activities of country-level procurement agencies, namely prequalification of pharmaceutical products and manufacturers; purchase of
...
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 com
...
Survey of the Quality of Selected Antimalarial Medicines Circulating in Six Countries of Sub-Saharan Africa
recommended
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
...
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
...
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
...
The intent of these guidelines is to develop a holistic, coordinated, proactive and technology driven strategy for management of biological disasters through a culture of prevention, mitigation and preparedness to generate a prompt and effective response in the event of an emergency. Th
...
This is the first NAP on the Prevention and Containment of AMR in Kenya. It has been developed based on the National Policy on Prevention and Containment of AMR and the recommendations of the situation analysis on AMR conducted in 2011 and updated in 2016. This strategy provides a
...
Replacement of Annex 2 of WHO Technical Report Series, No. 964
...
This new edition and fully updated publication replaces the 2012 UCG and is being circulated free of charge to all public and private sector prescribers, pharmacists, and regulatory authorities in the country
The framework is to be used as a reference guide, applied according to local priorities and needs, and targeted at academic institutions, educators, accreditation bodies, regulatory agencies and other users. The ultimate aim is to ensure that all he
...
This publication describes an arduous campaign to tackle the use of antimicrobials - specifically antibiotics - in the Danish swine-producing sector thanks to the collaboration between the regulatory sector within the Ministry of Environment and Foo
...
This report provides an update on the key facets of HIV treatment access, including the latest HIV treatment guidelines from World Health Organization (WHO), an overview on pricing for first-line, second-line, and salvage regimens, and a summary of the opportunities for – and threats to – expand
...
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
...
This third booklet of the World Drug Report 2022 has a dual focus: opioids and cannabis.
The first chapter of the booklet provides an overview of opioids as a group of substances and their patterns of non-medical use at the global level. It also reviews the latest trends in the global supply of opi
...
Comprehensive Reviews in Food Science and Food Safety, Vol.12 (2013) pp.234-248
In 2006, the Institute of Food Technologists (IFT) published an Expert Report entitled “Antimicrobial Resistance: Implications for the Food System” (IFT 2006). That report summarized current scientific knowledge pe
...
Updated with information on Ebola virus disease and Middle East respiratory syndrome coronavirus
A wide variety of health events ranging in severity may occur related to air transport, requiring different responses or, perhaps, no response at all. The target audience for this guidance document incl
...
This curricula guide builds on several existing products of WHO and partners, aimed at supporting countries in their effort to address the first objective of the GAP-AMR (to improve awareness and understanding of AMR). It is targeted specifically at health educators and policy planners, and applies
...
PHARMA’S RESPONSE TO THE COVID-19 VACCINES CRISIS. Update Feb., 14, 2022. In September 2021, Amnesty International published A Double Dose of Inequality, which assessed the extent to which the pharmaceutical industry was restricting access to Covi
...
Antimicrobial resistance (AMR) has emerged as a leading cause of death in the African region, surpassing fatalities from malaria, HIV, and TB. In response to this critical threat, the region has adopted the AMR Global Action Plan and the African Union Framework for Antimicrobial Resistance Control 2
...
This field study to measure access to and use of medicines was undertaken in GHANA in May-June 2008. The study assessed information on the socio-economic level of households, and access to and use of medicines for acute and chronic conditions as well as opinions and perceptio
...
Drug Advisory Board
Annex 5, WHO Technical Report Series 1010, 2018
Therapeutics Information and Pharmacovigilance Centre | TIPC
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.
First edition, November 1997 | Revised July 2002
Situational Analysis: 13-23 October 2014
Report prepared using the WHO/SEARO workbook tool for undertaking a situational analysis of medicines in health care delivery in low and middle income countries
Report prepared using the WHO/SEARO workbook tool for undertaking a situational analysis of medicines in health care delivery in low and middle income countries
Guidelines for Medicine Donations
recommended
This 3rd edition of Guidelines for medicine donations has been developed by the World Health Organization (WHO) in cooperation with major international agencies active in humanitarian relief and development assistance. The guidelines are intended to improve the quality of medicine donations in inter
...
Millennium Development Goal 8E aims for affordable access to essential medicines. Essential medicines, as defined by WHO, are those that “satisfy the health-care needs of the majority of the population” and that should therefore “be available at all times in adequate amounts”. However, there
...
The growing challenges for people in low and middle-income countries to access new medicines.
Analysis 58
Access to controlled medicines. 3rd edition
Zambia Essential Medicines List (ZEML) 05
recommended
2020 Version
Antibiotics and other antimicrobial agents are invaluable life savers, particularly in resource-limited countries where infectious diseases are abundant. Both uncomplicated and severe infections are potentially curable as long as the aetiological agents are susceptible to the
...
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
...
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.
Southern Med Review (2009)2;1:2-6
Full eHandbook under: http://www.msh.org/resources/health-systems-in-action-an-ehandbook-for-leaders-and-managers
Effective supply management has the potential to make a powerful contribution to the reliable availability of essential medicines, which are a crucial part of the delivery of highqualit
...
Médecins sans Frontières access campaign
Issue Brief
Accessed: 28.11.2019
The increasing global trend of Antimicrobial resistance (AMR) has gradually emerged as a major public health challenge for the entire world. AMR has spread to almost all countries and regions, including Pakistan owing to the “misuse and overuse” of Antimicrobials, contributing to the increasing
...
Pakistan Global Antibiotic Resistance Partnership (GARP) was formed in the wake of international and national efforts for AMR curtailment. A group of experts from microbiology, infectious diseases and veterinary medicine formed a core group at the organizational meet
...
COVID-19 Vaccines: 1 Safety Surveillance 2 Manual
While there is no indication that pregnant women have an increased susceptibility to infection with SARS-CoV-2, there is evidence that pregnancy may increase the risk of severe illness and mortality from COVID-19 disease in comparison with non-pregn
...
WHO/UNICEF/UNFPA joint statement
Antibiotics 2022, 11(3), 329; https://doi.org/10.3390/antibiotics11030329.
The authors found that the most-represented antibiotics on the Rwandan market were amoxicillin, co-trimoxazole and cloxacillin. No counterfeit antibiotics were found in this study. However, substandard batches with moderate
...
For the Fiscal Year 2015-2016, the Health Sector continued to implement actions meant to improve the availability, and access to quality healthcare. The following report highlights achievements registered by the health sector for the fiscal 2015-2016 in different health programs, as well as in the a
...
The most significant finding of the case study for integrating antimicrobial resistance (AMR)into existing programs and mobilising resources for funding in Nigeria, is that most of the AMR activities within the Nigerian National Action Plan (NAP)canalready be incorporated within exi
...
Early-warning indicators to prevent stock-outs and overstocking of antiretroviral, antituberculosis and antimalaria medicines.
The objectives of the meeting were to agree on coordinated and aligned support to the 3 countries’ national health recovery plans (Guinea, Liberia, Sierra Leone); to identify cross-cutting areas and opportunities for integration; to identify ways to improve implementation modalities; and to identi
...
Prices people pay for medicines.
Guidelines for Handling Temperature Sensitive Vaccines and Pharmaceuticals
Report of a mission 20–24 April 2015
WHO today published the new edition of its Model Lists of Essential Medicines and Essential Medicines for Children, which include new treatments for various cancers, insulin analogues and new oral medicines for diabetes, new medicines to assist people who want to stop smoking, and new antimicrobials
...
The threat posed by antimicrobial resistance (AMR) to public health as well as global health security has been reiterated in umerous World Health Assembly (WHA) resolutions. AMR is also prioritized under the Global Health Security Agenda (GHSA), and India is one of the contributing countries. The Mi
...
The escalating antimicrobial resistance (AMR) pandemic is a global public health threat with extensive health, economic and societal implications. Resistance emerges because of selection pressure from rational and indiscriminate antimicrobial use in human health as well as in the veterinary, agricul
...
Interim Guidance October 2022. This addendum addresses some of the methodological aspects of VE evaluations that have been learned during the past year, as well as those that have become relevant in the current epidemiological setting of the COVID-19 pandemic. For some of the COVID-19 vaccine method
...
2016 ASCO EDUCATIONAL BOOK | asco.org/edbo
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
...
Malawi Internationally recommended key policies uptake
Review over the work and challenges of the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC) in combatting counterfeiting of medicines in Nigeria.
Report of the Review Committee on the Functioning of the International Health Regulations (2005) in relation to Pandemic (H1N1) 2009
Improving Infection Prevention and Control Practices at Health Facilities in Resource-Limited Settings
recommended
SIAPS Technical Report. This report summarizes key accomplishments and lessons learned in implementing SIAPS’ approach to improving IPC practices in four countries: South Africa, Namibia, Jordan, and Ethiopia. All activities address SIAPS’s overall objective to build or enhance national and faci
...
