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.
Injection practices worldwide and especially in low- and middle-income countries (LMICs) include multiple, avoidable unsafe practices that ultimately lead to the large-scale transmission of bloodborne viruses among patients, health care providers and the community at large.
This document builds on the Background document prepared for the September 4-5, 2014 Consultation. It includes proposed elements to consider during the development of a framework to assist decision-making at global and national level.
The aim of the document is to assist Member States and releva...nt partners in their discussions to identify the best approaches to ensure the accelerated evaluation and use of available or near-term therapies and vaccines for the treatment and prevention of EVD. The document calls for a coordinated effort by the international community to remove unnecessary obstacles towards this goal.
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Today, patient harm due to unsafe care is a large and growing global public health challenge and is one of the
leading causes of death and disability worldwide. Most of this patient harm is avoidable. As countries strive to
achieve universal health coverage and the Sustainable Development Goals, t...he beneficial effects of improved
access to health services can be undermined by unsafe care. Patient safety incidents can cause death and
disability, and suffering for victims and their families. The financial and economic costs of safety lapses are high.
There is often reduced public confidence and trust in local health systems when such incidents are publicized.
Health workers involved in serious incidents involving death or serious harm to a patient can also suffer lasting
psychological harm and deep-seated feelings of guilt and self-criticism.
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This document is a guide defining requirements for quality and safety for malaria rapid diagnostic testing services to safeguard the quality of the results, the safety of the operators and patients and that of the environment for use by national malaria control programmes, regulators, implementers a...nd rapid diagnostic providers.
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Reporting system for the general public - This document aims to provide practical guidelines on how to set up national systems for consumers to report adverse reactions to medicines. The purpose is to help countries set up a well-organized and effective consumer reporting system within their pharmac...ovigilance centre. Throughout this document, the phrase “consumer reporting” is used to refer to reporting of adverse drug reactions (ADRs) by the general public.
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The position papers are intended for use by national public health officials and managers of immunization programmes. They may also be of interest to international funding agencies, vaccine advisory groups, vaccine manufacturers, health professionals, researchers, the scientific media and the genera...l public.
Les notes de synthèse s’adressent aux responsables nationaux de la santé publique et aux administrateurs des programmes de vaccination, mais elles peuvent également présenter un intérêt pour les organismes internationaux de financement, les groupes consultatifs sur la vaccination, les fabricants de vaccins, les professionnels de la santé, les chercheurs, les médias scientifiques et le grand public.
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an operational guide to support all those responsible for planning and implementing the rollout of COVID-19 vaccine to refugees and migrants at national and local levels, 14 March 2022
10 May 2021. Manufactureres:
SK Bioscience Co. Ltd. [COVID-19 Vaccine (ChAdOx1-S [recombinant])]
Serum Institute of India Pvt. Ltd. [COVISHIELD™, ChAdOx1 nCoV-19 Corona Virus Vaccine (Recombinant)]
The ChAdOx1-S/nCoV-19 [recombinant] vaccine is a replication-deficient adenoviral vecto...r vaccine against coronavirus disease 2019 (COVID-19). The vaccine expresses the SARS-CoV-2 spike protein gene, which instructs the host cells to produce the protein of the S-antigen unique to SARS-CoV-2, allowing the body to generate an immune response and to retain that information in memory immune cells. Efficacy shown in clinical trials in participants who received the full series of vaccine (2 doses) irrespective of interval between the doses was 63.1%, based on a median follow-up of 80 days, but tended to be higher when this interval was longer. The data reviewed at this time support the conclusion that the known and potential benefits of ChAdOx1-S/nCoV-19 [recombinant] vaccine outweigh the known and potential risks.
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