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.
Evidence for improving community health supply chains from Ethiopia, Malawi and Rwanda. Journal of Global Health vol. 4 No.2 (2014)
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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This is a detailed manual giving a step by step approach to undertaking the pharmacovigilance of antiretrovirals. It is intended to be a source of practical advice for Pharmacovigilance Centres and health professionals involved in HIV/AIDS prevention and treatment programmes. A number of WHO publica...tions are available that provide a background to pharmacovigilance and, as far as possible, that material will not be repeated here. Health officials, planners, the staff of Pharmacovigilance Centres, public health teams and all health workers should become familiar with these publications, which are: • Safety of Medicines: A guide to detecting and reporting adverse drug reactions
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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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In 2013, WHO and the Foundation for Innovative New Diagnostics convened a meeting of Buruli ulcer experts in Geneva, Switzerland (9) at which two priority unmet needs in diagnosis were identified:
a diagnostic test for early detection of Buruli ulcer in symptomatic patients with sufficient positive... predictive value to put patients on appropriate treatment; and
a screening test at the primary health care or community level for symptomatic patients with ulcer
In March 2018, they convened a global meeting with the aim of establishing an action plan to develop new diagnostic solutions for Buruli ulcer and to create a framework of collaboration to address unmet needs in diagnostics for the disease. The participants agreed to develop a target product profile (TPP) to address the need for a rapid diagnostic test for use at the primary health-care level.
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A toolkit for pharmacists.
Emerging data show that medication errors and adverse events cause significant harm to patients’ health and
well-being. It is estimated that the burden of adverse events due to medicines is now comparable to that of
widespread diseases, such as malaria or tuberculosis....1 The impacts of medication errors also represent a
burden for health systems, with the annual cost associated with medication errors estimated at USD 42 billion
worldwideharm
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This report reviews and analyses the Affordable Medicines Programme, which was introduced in Ukraine in April 2017 to provide patients with improved access to 23 outpatient medicines for the treatment of chronic noncommunicable diseases. The evaluation combines both quantitative and qualitative anal...ysis. The findings confirm that the Programme has contributed to a significant increase in access to needed outpatient medicines in Ukraine. Further, while implementation was successful overall, uptake across regions was uneven. The report concludes by listing a number of policy options to support the sustainability and expansion of the Affordable Medicines Programme.
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Building laboratory testing capacity
USAID Senegal and Health in Africa (HIA) initiative of the World Bank Group engaged the Strengthening Health Outcomes through the Private Sector (SHOPS) project to conduct an assessment of the private health sector in Senegal. The assessment’s primary focus is family planning, and its secondary fo...cus is maternal, neonatal and child health (MNCH), HIV and AIDS, malaria, and nutrition.
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MINISTERIAL ORDER Nº 002/17/10/TC OF 27/10/2017 DETERMINING THE FEES FOR REGISTRATION OF PHARMACEUTICAL PRODUCTS, MEDICAL DEVICES AND OTHER RELATED SERVICES | Official Gazette nº 46 of 13/11/2017
SHOPS and HIA finalized a scope of work with USAID Senegal in April 2015, and a team of five private sector experts conducted the onsite assessments between May and June 2015. The Private Sector Assessment (PSA) team worked closely with Senegalese key stakeholders throughout the process. The PSA tea...m interviewed more than120 individuals from approximately 78 organizations, including the government of Senegal (GOS), donors, USAID implementing partners, private sector umbrella organizations, private insurance companies, faith-based organizations (FBOs), nongovernmental organizations (NGOs), private health care facilities, and private pharmacies.
Through stakeholder interviews and review of government reports and online resources, the assessment team noted the following findings by theme.
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This field study to measure access to and use of medicines was undertaken in GHANA in May-June 2008. The study assessed information on the socio-economic level of households, and access to and use of medicines for acute and chronic conditions as well as opinions and perceptio...ns about medicines. The survey was conducted in six regions. In each region, six reference public heath care facilities were selected among those participating in the Level II Facility Survey that was carried out in parallel. Within defined distances from each reference public health care facility, households were selected by purposive cluster sampling. A total of 1065 household respondents were interviewed by means of a structured paper questionnaire
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Afr J Tradit Complement Altern Med. (2013) 10(5):210-229
Plants are important sources of medicines. Herbal medicines in Lesotho are exposed to excessive exploitation and habitat destruction. Comprehensive information to promote proper use and conservation of these herbal medicines is lacking. ...This study described the uses of medicinal plants in Lesotho with comparative reference between practice and the literature, highlighting important ethno-medicinal information and conservation status of the plants. Additionally, the study established a repository and monograph for the herbal medicines in Lesotho.
http://dx.doi.org/10.4314/ajtcam.v13i1.20
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