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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...
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
...
The provision of safe and efficacious blood and blood components for transfusion or manufacturing use involves a number of processes, from the selection of blood donors and the collection, processing and testing of blood donations to the testing of patient samples, the issue of compatible blood and ...
The project will support preventive actions, traditional medicine and the coordination and
implementation capacities of the national framework for HIV/AIDS control.
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.
As we approach World Asthma Day on the May 2, 2023, we reflect on the theme “ Asthma Care for All”. Prevalence of Asthma is increasing amongst children, adolescents and adults. Under-diagnosis, underutilization of inhaled corticosteroids, inaccessibility of treatment, and unaffordability of medi...
Tis first edition describes the standard operating procedures for health products for NTDs amenable to preventive chemotherapy and the medicines donated to treat them. These include albendazole for lymphatic filariasis and soil-transmitted helminthiases; azithromycin for trachoma and yaws; diethylca...
The report provides a brief introduction to patents and licences and their effect on the market for antiretroviral (ARV) medicines. It gives an overview of the patent landscape with respect to a select number of ARV medicines in developing countries as of April 2014. The focus is primarily on those ...
The recommendations cover the level of blood pressure to start medication, what type of medicine or combination of medicines to use, the target blood pressure level, and how often to have follow-up checks on blood pressure. In addition, the guideline provides the basis for how physicians and other h...
Fact Book on WHO Level I and Level II monitoring indicators - To monitor the progress of efforts to improve the global medicines situation, WHO has developed a system of indicators that measure important aspects of a country’s pharmaceutical situation. Level 1 indicators measure the existence and ...
Issue Brief 31: Antimicrobial resistance (AMR) can occur when viruses, bacteria, parasites and fungi change over time. There is no longer a response to medicines, and the infection treatment gets really difficult which increases the risk of a disesase spread, which can lead to severe health problems...
This guideline is intended to provide requirements to applicants wishing to submit
applications for registration of medicines in Botswana.
This user guide is designed to provide national malaria control programmes with general information on glucose-6-phosphate dehydrogenase (G6PD) deficiency. Individuals with this condition may be at risk of adverse effects from medicines commonly used to cure Plasmodium vivax malaria, as well as from...
Guidelines for the production of extemporaenous formulations and hospital based sterile preparations
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 ...
Healthy communities rely on well-functioning ecosystems. They provide clean air, fresh water, medicines and food security. They also limit disease and stabilize the climate. But biodiversity loss is happening at unprecedented rates, impacting human health worldwide, according to a new state of knowl...
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...
One health Response to AMR Containment.
In a significant move for the public health sector, Kerala has become the first state in India to launch an action plan to combat the growing cases of antimicrobial immunity, arising primarily from irrational use of medicines and excessive antibiotics used in...
One of the many gender inequities in the health and care workforce that COVID-19 has exposed is around the fit and design of Personal Protective Equipment (PPE). The rapid onset and scale of COVID-19 led to shortages of PPE in most countries, causing preventable infection and mortality among healthc...
How to address the global crisis in antibiotic research and development.
The report includes a comprehensive summary and critical evaluation of recent initiatives to overcome the barriers to achieve sustainable access to antibiotics. As antibiotic resistance will continue to develop as long as we ...
Antimicrobial resistance (AMR) is described as a situation when bacteria, viruses, fungi and parasites
change over time and no longer respond to medicines, making infections harder or impossible to treat,
and increasing the risk of disease spread, severe illness and death.1 AMR in recent years has...
