Document No. : FDA/SMC/SMD/GL-SMP/2015/05 |
These guidelines are for information, guidance and strict compliance by Marketing Authorization Holders and
...
Local Representatives of regulated products to help in the continuous safety monitoring of products granted marketing authorization in Ghana.
more
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 for International Drug Monitoring (PIDM) and other partners, which was held on 20 October 2022.
more
Cases of monkeypox (MPX) acquired in the EU have recently been reported in nine EU Member States (Austria, Belgium, France, Germany, Italy, Portugal, Spain, Sweden, and the Netherlands).
Monkeypox (MPX) does not spread easily between people. Human-
...
to-human transmission occurs through close contact with infectious material from skin lesions of an infected person, through respiratory droplets in prolonged face-to-face contact, and through fomites. The predominance, in the current outbreak, of diagnosed human MPX cases among men having sex with men (MSM), and the nature of the presenting lesions in some cases, suggest transmission occurred during sexual intercourse
more
Document No. : FDA/SMC/SMD/GL-RAR/2013/01
This study addresses part of the Terms of Reference for a scoping report ‘An analysis of approaches to laboratory capacity strengthening for drug resistant infections in low and middle income coun
...
tries’. It has been produced as a separate report because it is also very relevant for a second study ‘Supporting Surveillance Capacity for Antimicrobial Resistance: Regional Networks and Educational Resources’. This study compares antimicrobial surveillance systems in three low and middle income countries in order to describe the components of these systems and to understand which surveillance models are best suited to particular contexts. Ghana, Nigeria and Nepal were selected as study countries because they cover different continents and include one ‘fragile’ context (Nigeria). Brief information from Malawi is also included.
more
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 deviations were found, suggesting that regular quality control of antibiotics is needed in Rwanda.
more
The conduct of COVID-19 vaccine trials in the context of a candidate vaccine being issued with Emergency Use Designation raises challenging ethical questions, including in relation to the use of placebo controls and unblinding of trial participants
...
in current and future COVID-19 vaccine trials. This policy brief was developed by the WHO Access to COVID-19 Tools (ACT) Accelerator Ethics & Governance Working Group, to provide guidance for researchers, sponsors, regulators, research ethics committees, and policy-makers, on these and related issues.
more