In September, 2018, the first international Medicine Quality and Public Health Conference was held at Oxford University, UK, to discuss opportunities and solutions to ensure that all people have access to affordable and quality-assured medical products. Delegates developed the short Oxford Statement..., calling for investment, policy change, and action to eliminate substandard and falsified medical products. The statement was born out of discussion between governments, national and international agencies, non-governmental organisations, professional associations, and academic institutions who together examined the latest evidence on the epidemiology and public health implications of substandard and falsified medical products.
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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
This 3rd edition of Guidelines for medicine donations has been developed by the World Health Organization (WHO) in cooperation with major international agencies active in humanitarian relief and development assistance. The guidelines are intended to improve the quality of medicine donations in inter...national development assistance and emergency aid. Good medicine donation practice is of interest to both donors and recipients...
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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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The purpose of these guidelines is to help health workers to participate in the process of continuous surveillance of safety and efficacy of the pharmaceutical products which are used in clinical practice, thus help to achieve the ultimate goal to make safer and more effective treatment available to... patients. This guideline addresses specifically the issues on what to report, why to report, when to report, where to report and how to report.
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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.
Namibia guideline for submission of applications for registration of pharmaceuticals for human use in common technical document format.
short information for migrants on how to access medicines in Germany
This guide provides national stakeholders and advocates with information and guidance to update the national essential medicines list to include a new commodity, a new indication, or a new formulation based on the available evidence and based on country need and disease burden. While the actors, tim...eline, and process may vary from country to country, this guide presents the broad steps involved in revising an EML for any health commodity. Additional resources and a glossary are included to provide supplemental information and to clarify key terms.
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The product of all this work is the Standard Treatment Guideline and Essential Medicines List of Common Medical Conditions in the Kingdom of Swaziland. These systematically developed statements are designed to assist practitioners in making decisions about appropriate treatment for specific clinical... conditions. They are meant to reflect expert consensus based on a review of current and published scientific evidence of acceptable approaches to diagnosis, man-agement, or prevention of specific conditions.It is enlightening to note that section A of the document contains the STG, and effort has been made to have the conditions commonly encountered in Swaziland classified according to systems. Written in simple, clear language, each section consists of a short definition followed by common symptoms and signs of the disease or condition and then management (pharmacological and nonpharmacological)
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The Animal Medicines Best Practice (AMBP) programme: developed by NOAH in partnership with stakeholders along the food supply chain to improve co-ordination and consistency in approach to the responsible use of medicines. Training modules are available for dairy, beef, sheep and pig farmers on the r...esponsible use of antibiotics.
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Using the WHO model list of essential medicines to update a national essential medicines list
Since 1977, WHO has been working with countries to design the package of essential medicines as an integral component of treatment within the continuum of care, developing and disseminating the Model List ...of Essential Medicines (Model List). WHO is committed to supporting Member States in sharing best practices in selecting
essential medicines, and in developing processes for the selection of medicines for national essential medicines lists (national EMLs, or NEMLs) consistent with the evidence-based methods used for updating the WHO Model List.
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The procurement of essential medicines and other health products is a critical function in support of the effective discharge of WHO’s mandate, and WHO values the importance of the quality of essential medicines and health products that are supplied to countries. The first World Health Assembly in... 1948 recognized the need to establish a procurement service at WHO, and recommended setting up an office “to give advice on the procurement of essential drugs, biological products and other medical supplies”.
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