UNAIDS/99.31E (English original, June 1999)
1st revision, April 2000
This document is part three in a series of explainers on vaccine development and distribution. Part one focused on how vaccines work to protect our bodies from disease-carrying germs. Part two focused on the ingredients in a vaccine and the three clinical trial phases.
This document outlines the... next part of the vaccine journey: the steps from completing the clinical trial phases through to distribution.
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BioMed Central; BMC International Health and Human Rights (2016) 16:20; DOI 10.1186/s12914-016-0094-y
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.
Every day, fake medicines and medical products are sold at street corners, in open air markets or on unregulated websites in several countries in the African Region. These poor quality, unsafe medicines and pharmaceutical products promote drug resistance and lead to loss of confidence in health prof...essionals, manufacturers and distributors and in health systems. In an effort to protect people’s health, the WHO Regional Director for Africa, Dr Matshidiso Moeti, has proposed a strategy aimed at strengthening National Medicine Regulatory Authorities (NMRAs) in order to ensure that only safe, good quality and effective medical products are available.
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24 September 2021. The vaccine has been authorized by the Chinese National Regulatory Authority (NRA) – the National Medicinal Product Administration (NMPA) – as well as other regulatory authorities. Because WHO has granted Emergency Use Listing (EUL) for the Sinovac COVID-19 vaccine (Vero Cell ...[Inactivated]) – CoronaVac, the Africa Union and Africa CDC’s Regulatory Taskforce has endorsed the Emergency Use Authorisation for the vaccine (see scenario #1). As such, African Union Member States are recommended to waive any review processes and rely directly on the WHO EUL via the AVAREF managed pathway described in Scenario #1
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Annex 5, WHO Technical Report Series 1010, 2018
Mental health problems are common and cause great suffering to individuals and communities around the world. They have a significant impact not only on the physical and mental health of those affected but also on their families and the communities they live in. At the same time, all communities have... their own traditional mechanisms for support and contain a range wide of resources that can be helpful in preventing mental health conditions from developing, promoting positive mental health and supporting the recovery of people that are struggling with a mental health condition.
In the wider context, people living with a mental health condition are often excluded from their communities and experience various violations to their basic human rights (discrimination, violence, exclusion from employment opportunities). The World Health Organization (WHO) estimates that the mean prevalence of global mental health disorders is 10.8% while the prevalence in emergency settings is 22.1% in any conflict-affected population.
During emergencies and crisis, the stigma, exclusion and discrimination towards people living with mental health conditions is often higher, which can cause isolation and protection issues. Communities can play a crucial role in promoting mental health as well as enhancing primary care and access. Their role is to help reduce mental health inequalities by providing community resources that connect people to community-based resources and by providing mental health education. This also helps to reduce the massive mental health treatment gap.
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Good Manufacturing Practice (GMP) describes a set of principles and procedures that, when followed, ensure that medicines and related substances are of high quality, safety and efficacy. SAHPRA is a
participating authority of the Pharmaceutical Inspection Cooperation Scheme (jointly known as PIC/S).... PIC/S aims to develop international standards between countries and pharmaceutical inspection
authorities, to provide harmonised and constructive co-operation in the field of GMP. PIC/S affiliation is subject to initial and periodic assessment of the participating authority to ensure that it has equivalent legislation, regulatory and enforcement procedures and inspection capacity.
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MMWR. Recommendations and Reports:
December 16, 2005 / 54(RR15);49-55