The manufacturing process is one of the key steps where quality control is required to ensure quality of medicinal products, including herbal medicines. Good manufacturing practices (GMP) is one of the most important tools for this measure.
The Kenya Essential Medicines List 2019 is an indispensable guide to the medicines recommended for the management of common conditions in Kenya. It is primarily directed at health care providers and medicines supply managers in the public and non-public health sectors. It should be used together wit...h the current versions of updated national clinical guidelines for those conditions for which such guidelines exist
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6th edition, The NLEM 2021 contains 398 drugs molecules in different therapeutic categories.
The 23rd meeting of the WHO Expert Committee on Selection and Use of Essential Medicines was coordinated from Geneva, Switzerland, and held virtually from 21 June to 2 July 2021. The Committee considered 88 applications proposing additions, changes and deletions of medicines, medicine classes and fo...rmulations on the Model Lists of Essential Medicines. The Committee evaluated the scientific evidence for comparative effectiveness, safety and cost-effectiveness of the medicines in question. The Committee also considered a review of the therapeutic alternatives for medicines on the Model Lists, and update to the AWaRe classification of antibiotics, and reviews and reports relevant to the selection and use of essential medicines.
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The primary role of Benin’s Department of Pharmacy and Medicines (DPMED) is to develop and apply the national pharmaceutical policy. The main objective of this policy is to ensure the availability and accessibility of quality medicines for the population. To fulfill its mandate, DPMED aims to stre...ngthen its regulatory capacity, including the issuance of licenses to pharmaceutical establishments and the registration of pharmaceutical products. Benin’s current registration system shares core concerns that are common to most developing countries, notably the capacity to evaluate and monitor the security, efficacy, and quality of medicines and other health products. It is currently characterized by 1) poor or inadequate traceability of records or regulations (example: a product’s marketing authorization [MA] is often hard to find); 2) lack of evidence used in the regulatory decision-making process (reasons behind special import authorization, i.e., products without valid MAs); 3) inconsistent and unsecured archiving system; 4) limited human resources; and 5) an inefficient information management system
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Technical Report
AIDS Medicines and diagnostics service
September 2016
Millennium Development Goal 8E aims for affordable access to essential medicines. Essential medicines, as defined by WHO, are those that “satisfy the health-care needs of the majority of the population” and that should therefore “be available at all times in adequate amounts”. However, there... is a category of medicines that faces a unique challenge in terms of availability. These are the medicines governed by the international conventions on narcotic and psychotropic substances. “Controlled medicines” is the common definition for pharmaceuticals whose active principles are listed under the 1961 United Nations Single Convention on Narcotic Drugs as amended by the 1972 Protocol, such as morphine and methadone; the 1971 United Nations Convention on Psychotropic Substances, such as diazepam and buprenorphine; and the 1988 United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, such as ergometrine and ephedrine. The conventions list substances in “Schedules” according to their different levels of potential for abuse and harm, and the commensurate severity of control measures to be applied by countries.
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PQM conducted an assessment of the medicine quality assurance and quality control systems in Rwanda during November 9-13, 2009. Medicine quality assurance remains to be developed in Rwanda: the country has neither a medicine regulatory authority (MRA) nor a national medicine quality control laborato...ry – the two key institutions to ensure the quality, safety, and efficacy of medicines. The MOH Pharmacy Taskforce (PTF) is to be commended however for successfully controlling the pharmaceutical market to the extent that there is no informal medicines market in Rwanda. Based on its findings, the assessment team expects Rwanda to be able to make great strides in evidence-based medicines quality assurance in the short to medium term, provided it receives adequate technical assistance and financial support.
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Introduction
Chapitre A.6
Edition en français Traduction : Cristina Constantin Sous la direction de : Priscille Gérardin Avec le soutien de la SFPEADA
Long Acting Muscarinic Antagonists (LAMA) such as tiotropium and glycopyrronium are used in the management of COPD1. They have been shown to improve lung function, quality of life and exercise tolerance. They have also been associated with reduced COPD-related exacerbations, associated hospitalisati...ons and duration of hospital stay. Both the South African Thoracic Society (SATS) and Global Initiative for Chronic Obstructive Lung Disease (GOLD), guidelines recommend the use of long acting anticholinergic drugs (or long acting beta agonists) in moderate to very severe disease as defined by lung function (FEV1). The most up to date guideline, utilizing the GRADE methodology (European Respiratory Society guidelines of 2017), confirms their superiority over long acting β agonists (LABA) as monotherapy for COPD in that LAMA's have demonstrated greater efficacy in terms of exacerbation reduction, with similar safety profile.2 These recommnedations are supported by published peer-reviewed
evidence including individual papers and Cochrane reviews.
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