Improving medicines regulation in sub‐Saharan Africa

Ndomondo-Sigonda et al. (2017) observed that there is scarcity of information on human resources (person-nel devoted to regulation of medicines) in the domain of medicines regulation in the sub-Saharan Africa (SSA). The published information on medicines regulation by the National Medicines Regulatory Authorities (NMRAs) in the Economic Community of West African States (ECOWAS) region are no longer current and consistent with the current realities in the NMRAs. In order to reveal this occurrence, show the trends that exist over the years and make appropriate recommendations, data were collected and compared from 2005, 2010 and 2017 research reports on seven regulatory features of the fifteen Members States of ECOWAS. The re-sults show that there was missing information per regulatory feature and country. There was also an overall increasing trend in the number of NMRAs in the region that showed progress with respect to the measured regulatory features - Autonomy (Authority and Legal form), Marketing Authorization), GMP inspection, Quality Control, Quality Management System, Information Management System and Harmonization and International cooperation. People of Africa have a valuable story to tell as it relates to medicines regulation. This report is written by a West African from the perspective of a West African involved in the study and practice of medi-cines regulation by the NMRAs in the ECOWAS.

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RTS,S/AS01, a vaccine targeting pre-erythrocytic stages of Plasmodium falciparum

Emerging Topics in Life Sciences ◽

10.1042/etls20170101 ◽

2017 ◽

Vol 1 (6) ◽

pp. 533-537

Author(s):

Lorenz von Seidlein ◽

Borimas Hanboonkunupakarn ◽

Podjanee Jittmala ◽

Sasithon Pukrittayakamee

Keyword(s):

Protective Efficacy ◽

Age Groups ◽

Sub Saharan Africa ◽

Phase Iii ◽

European Medicines Agency ◽

Older Children ◽

Pivotal Phase ◽

Malaria Epidemiology ◽

Maximum Benefit ◽

Sub Saharan

RTS,S/AS01 is the most advanced vaccine to prevent malaria. It is safe and moderately effective. A large pivotal phase III trial in over 15 000 young children in sub-Saharan Africa completed in 2014 showed that the vaccine could protect around one-third of children (aged 5–17 months) and one-fourth of infants (aged 6–12 weeks) from uncomplicated falciparum malaria. The European Medicines Agency approved licensing and programmatic roll-out of the RTSS vaccine in malaria endemic countries in sub-Saharan Africa. WHO is planning further studies in a large Malaria Vaccine Implementation Programme, in more than 400 000 young African children. With the changing malaria epidemiology in Africa resulting in older children at risk, alternative modes of employment are under evaluation, for example the use of RTS,S/AS01 in older children as part of seasonal malaria prophylaxis. Another strategy is combining mass drug administrations with mass vaccine campaigns for all age groups in regional malaria elimination campaigns. A phase II trial is ongoing to evaluate the safety and immunogenicity of the RTSS in combination with antimalarial drugs in Thailand. Such novel approaches aim to extract the maximum benefit from the well-documented, short-lasting protective efficacy of RTS,S/AS01.

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Mortality and Society in Sub-Saharan Africa

Population Studies ◽

10.1080/0032472031000147416 ◽

1993 ◽

Vol 47 (3) ◽

pp. 555-556

Author(s):

Lado Ruzicka

Keyword(s):

Sub Saharan Africa ◽

Sub Saharan

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Sub-Saharan Africa

The Military Balance ◽

10.1080/04597228708459635 ◽

1987 ◽

Vol 87 (1) ◽

pp. 118-142

Keyword(s):

Sub Saharan Africa ◽

Sub Saharan

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Adolescent Suicidality as Seen in Rural Northeastern Uganda

Crisis ◽

10.1027/0227-5910/a000059 ◽

2011 ◽

Vol 32 (1) ◽

pp. 43-51 ◽

Cited By ~ 17

Author(s):

Eugene Kinyanda ◽

Ruth Kizza ◽

Jonathan Levin ◽

Sheila Ndyanabangi ◽

Catherine Abbo

Keyword(s):

Low Socioeconomic Status ◽

Sub Saharan Africa ◽

Psychosocial Risk ◽

Psychiatric Nurses ◽

Health Concern ◽

Cross Sectional ◽

Childhood Experiences ◽

Low Socioeconomic ◽

Dsm Iv ◽

Sub Saharan

Background: Suicidal behavior in adolescence is a public health concern and has serious consequences for adolescents and their families. There is, however, a paucity of data on this subject from sub-Saharan Africa, hence the need for this study. Aims: A cross-sectional multistage survey to investigate adolescent suicidality among other things was undertaken in rural northeastern Uganda. Methods: A structured protocol administered by trained psychiatric nurses collected information on sociodemographics, mental disorders (DSM-IV criteria), and psychological and psychosocial risk factors for children aged 3–19 years (N = 1492). For the purposes of this paper, an analysis of a subsample of adolescents (aged 10–19 years; n = 897) was undertaken. Results: Lifetime suicidality in this study was 6.1% (95% CI, 4.6%–7.9%). Conclusions: Factors significantly associated with suicidality included mental disorder, the ecological factor district of residence, factors suggestive of low socioeconomic status, and disadvantaged childhood experiences.

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