Licensed pharmaceutical products (marketing authorization) should be manufactured only by licensed manufacturers (holders of a manufacturing authorization) whose activities are regularly inspected by competent national authorities. This guide to GMP shall be used as a standard to justify GMP status,... which constitutes one of the elements of the WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce, through the assessment of applications for manufacturing authorizations and as a basis for the inspection of manufacturing facilities. It may also be used as training material for government medicines inspectors, as well as for production, QC and QA personnel in the industry
more
19 February 2021
The overall objective of this prospective meta-analyses (PMA) is to estimate the effect of anti-IL-6 therapy compared with usual care in hospitalized patients with suspected or confirmed COVID-19. The primary comparison is of the class effect of anti-IL-6 therapies. It will also es...timate the effects of specific anti-IL-6 therapies.
more
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
more
1 March 2021
The COVID-19 vaccine checklist is for frontline health workers planning a COVID-19 vaccination session. This checklist can help them to prepare and complete a COVID-19 vaccination session at a fixed post or outreach session.
Why are experts concerned about COVID-19 and antibiotics? And what can you do about it? Learn about antibiotics and COVID-19 from WHO’s Dr Hanan Balkhy in Science in 5
Country profile: Tanzania
Antimicrobial resistance (AMR) is a global public health crisis that resulted in 1.14 million deaths in 2021. According to the Institute for Health Metrics and Evaluation estimates, 96 416 of these deaths occurred in the World Health Organization (WHO) Eastern Mediterranean Region. All 22 countr...ies/territories in the Eastern Mediterranean Region are enrolled in the global AMR
surveillance system, and 17 countries/territories reported data in 2024 (for the year 2023). The total number of isolates reported to the system increased sixfold between 2017 and 2022, but the proportion of blood isolates is relatively very low. Most of the data come from public sector laboratories or hospitals, although the private sector has increased its participation in some countries/territories recently. Three pathogens account for three quarters of all the reported pathogens – Escherichia coli
(26%), Klebsiella pneumoniae (23%), and Staphylococcus aureus (22%).
more
The elimination scenario planning (ESP) manual provides malaria-endemic countries with a comprehensive framework to assess different scenarios for moving towards this goal, depending on programme coverage and funding availability. It also helps countries set realistic timelines and provides essentia...l knowledge for strategic planning in the long term.
more
The Global Programme on Tuberculosis & Lung Health of the World Health Organization (WHO/GTB) is now combining all current recommendations into one overall set of consolidated guidelines on TB. The guidelines contain recommendations pertaining to all areas related to the programmatic management of T...B (e.g. screening, preventive treatment, diagnostics, patient support, and the treatment of drug-susceptible TB and DR-TB). The consolidated guidelines contain modules specific to each programmatic area.
more
Building laboratory testing capacity