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This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of medicines. It represents the Medicines Control Council’s current thinking on the safety, quality and efficacy of medicines.
Drug registration in Kenya started in 1982; the process mainly involves an evaluation committee at the Kenya Pharmacy and Poisons Board (PPB) that aims to approve products based on quality, safety and efficacy.
Antimicrobial resistance (AMR) is a threat to human and animal health and refers to the ability of microorganisms to defy the medicines prescribed. For instance when antibiotics are used improperly, such as an incorrect dose, insufficient duration or wrong frequency, resistance is heightened. The mi...
Manufacturers:
SK Bioscience Co. Ltd. [COVID-19 Vaccine (ChAdOx1-S [recombinant])]
Serum Institute of India Pvt. Ltd. [COVISHIELD™, ChAdOx1 nCoV-19 Corona Virus Vaccine (Recombinant)]
Efficacy shown in clinical trials in participants who received the full series of vaccine (2 doses) ir...
The coronavirus disease 2019 (COVID-19) pandemic revealed systemic weaknesses in health-care systems
worldwide. The breadth of challenges left health workers overwhelmed and overstretched, reducing their professional efficacy and causing long-term issues with retention, recruitment and education of...
verall strategy and objective of the European Antibiotic Awareness Day The overall objective of the European Antibiotic Awareness Day is to support national activities aimed at raising awareness concerning the proper use of antibiotics so as to maintain the efficacy of antibiotics and avoid the eme...
Full Perscribing information on Fexinidazole Tablet for oral use
INDICATIONS AND USAGE
Fexinidazole Tablets are indicated for the treatment of both the first-stage (hemolymphatic) and second-stage (meningoencephalitic) human African trypanosomiasis (HAT) due to Trypanosoma brucei gambiense in pati...
Many countries are using the approach of mixing vaccine doses from different manufacturers. What do we know about the safety and efficacy of this approach? What does the evidence tell us about using a fraction of the vaccine dose ? Dr Katherine O’Brien explains in Science in 5 this week.
Closed C...
For the first time in almost 50 years there are two new drugs for the treatment of drug-resistant TB (DR-TB): bedaquiline and delamanid. There has also been increased attention given to the safety and efficacy of “re-purposed” drugs that have been widely used to treat other infections but are al...
There is strong demand for alternatives to pharmaceuticals for a variety of common illnesses due to concerns of safety, efficacy, and a desire for more “natural” products. Despite this growing interest, “conventional” healthcare providers may have little to no knowledge about herbal medicine...
This technical report summarizes the discussions on the status of programmatic transition to tenofovir, lamivudine and dolutegravir (TLD) in low– and middle- income countries, addressing the best practices and major challenges faced by HIV programmes.
The latest data on safety and efficacy of do...
The document "ABCs of Using a Nebulizer" by the American Lung Association provides instructions for using a nebulizer effectively for COPD or other lung conditions. It covers assembling the device, using it for treatment, and proper cleaning procedures to ensure medication efficacy. The guide also o...
The main objectives of these guidelines are to:
1. contribute to the quality assurance of medicinal plant materials used as the source for herbal medicines to improve the quality, safety and efficacy of finished herbal products; 2. guide the formulation of national and/or regional GACP guideli...
1. contribute to the quality assurance of medicinal plant materials used as the source for herbal medicines to improve the quality, safety and efficacy of finished herbal products; 2. guide the formulation of national and/or regional GACP guideli...
This document provides up-to-date guidance on laboratory studies as well as smallscale (semi-field) and large-scale field trials to assess the efficacy and determine field application rates of new molluscicide products for control of schistosomiasis.
Communication to Healthcare Professionals Mar-2020
This guideline is intended to assist healthcare professionals in the participation of very important process of continuous surveillance of safety and efficacy of the health products which are used in their clinical practice. Continuous evaluation o...
Essential Medicines are those that satisfy the priority health care needs of the population. They are selected with due regard to public health relevance, evidence on efficacy, safety and comparative cost-effectiveness. This edition of the Essential Medicines List (EML) 2017 for Ghana has been deriv...
The Ethiopian Food and Drug Administration (EFDA) is mandated, in the proclamation 661/2009, to ensure the safety, quality and efficacy of medicines. To achieve this, the authority has been working on different regulatory activities. The medicine market authorization system is one of the top priorit...
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)...
Evidence-based guidelines are one of the most useful tools for improving public health and clinical practice. Their purpose is to formulate interventions based on strong evidence of efficacy, avoid unnecessary risks, use resources efficiently, reduce clinical variability and, in essence, improve hea...
The protozoan parasite Trypanosoma cruzi causes Chagas disease, an important public health problem throughout Latin America. Current therapeutic options are characterised by limited efficacy, long treatment regimens and frequent toxic side-effects. Advances in this area have been compromised by gaps...
