This guideline is intended to provide requirements to applicants wishing to submit
applications for registration of medicines in Botswana.
Rwanda Guidelines for variation to registered pharmaceutical products.
These guidelines have been developed to provide guidance to the Ministry of Health in managing applications for registration of human pharmaceutical products in Rwanda. It was compiled by the Technical Working Group (TWG) on Medicines Evaluation and... Registration (MER) of the East African Community Medicine Regulatory Harmonization (EAC MRH) Project. The group relied on their experiences and knowledge on medicines registration requirements of their individual Countries. World Health Organization (WHO) and the International Conference on Harmonization of Technical Requirements of Medicines for Human Use (ICH) and other available literature.
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Health system resilience is not an inevitable byproduct of any investment in health but must be intentionally programmed and developed with necessary input, investment and contextualization. This technical product aims to guide national, subnational..., and global health actors to operationalize the concept of health system resilience for advancement of universal health coverage, health security and ultimately better health for all. It supports the translation of relevant conceptual guidance and high-level recommendations into practical actions.
The specific objectives are to:
present a concise overview of the concept of health system resilience;
provide a roadmap outlining practical and foundational steps for building health system resilience to be adapted to different contexts;
share examples of actions and tools, including stakeholder roles, to support country application of the roadmap.
The target audience for this work is the various stakeholders involved in strengthening health systems and public health including management of emergencies (from prevention and preparedness to response and recovery) and other public health challenges in countries. This ranges from the donors, policy-makers and decision-makers at global, national and subnational levels to the implementing institutions and line managers of health system functions and services across the health system building blocks.
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WHO recently conducted a survey to assess the availability and cost of a national tracer list of essential medicines in the outpatient sector in Ukraine using a new collection tool – the WHO Essential Medicines and Health Products Price and Availa...bility Monitoring Mobile Application. This tool facilitates rapid and inexpensive data collection at the facility level.
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Essential Medicines and Health Products Information Portal
In order to streamline and effectively control compounding of medicinal products in hospitals and pharmacies, these Guidelines for Production of Extemporaneous and Hospital Based Sterile Preparation...s has been crafted. The purpose of these guidelines therefore is to assist pharmacists in discharging their legal and professional obligations to patients in the area of extemporaneous dispensing. This guidance will help to assure the safe and appropriate preparation and supply of extemporaneously prepared medicinal products to patients, where
the supply of such products is necessary.
Extemporaneous and hospital based sterile preparations are critical for patients whose clinical needs cannot be met by registered medicinal products. The guidelines outline the principles and application of the concepts of Good Manufacturing Practice (GMP) requirements for premises, equipment, personnel, storage, quality management system, quality control, compounding processes as well as documentation.
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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.
WHO recently conducted a survey to assess the availability and cost of a national tracer list of essential medicines in the outpatient sector in Ukraine using a new collection tool – the WHO Essential Medicines and Health Products Price and Availa...bility Monitoring Mobile Application. This tool facilitates rapid and inexpensive data collection at the facility level.
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The survey aimed at evaluating the quality of selected antimalarials in six countries of sub-Saharan Africa (Cameroon, Ethiopia, Ghana, Kenya, Nigeria and the United Republic of Tanzania). These countries have been supported by WHO to strengthen their regulatory controls o...ver antimalarial products. The survey was organized independently of manufacturers of antimalarial 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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A Global Analysis of Antimicrobial Resistance and Its Drivers.
Since the first State of the World’s Antibiotics report in 2015, antimicrobial resistance has leveled off in some high-income countries but continues to rise in many low- and middle-income countries (LMICs), where access to antibiotic...s has risen with increases in gross domestic product per capita. Per capita antibiotic consumption in LMICs is lower than in high-income countries, despite a higher infectious disease burden; however, consumption rates are rapidly converging. These trends reflect both better access to antibiotics for those who need them and increases in inappropriate antibiotic use.
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Introduction Pharmacovigilance (PV) systems to monitor drug and vaccine safety are often inadequate in sub-Saharan
Africa. In Malawi, a PV enhancement initiative was introduced to address major barriers to PV.
Objective The objective of this initiative was to improve reporting of adverse events (A...Es) by strengthening passive safety
surveillance via PV training and mentoring of local PV stakeholders and healthcare providers (HCPs) at their own healthcare
facilities (HCFs).
Methods An 18-month PV training and mentoring programme was implemented in collaboration with national stakeholders,
and in partnership with the Ministry of Health, GSK and PATH. Two-day training was provided to Expanded Programme on
Immunisation coordinators, identified as responsible for AE reporting, and four National Regulatory Authority representa-
tives. Abridged PV training and mentoring were provided regularly to HCPs. Support was given in upgrading the national
PV system. Key performance indicators included the number of AEs reported, transmission of AE forms, completeness of
reports, serious AEs reported and timeliness of recording into VigiFlow.
Results In 18 months, 443 HCPs at 61 HCFs were trained. The number of reported AEs increased from 22 (January 2000 to
October 2016) to 228 (November 2016 to May 2018), enabling Malawi to become a member of the World Health Organization
Programme for International Drug Monitoring. Most (98%) AE report forms contained mandatory information on reporter,
event, patient and product, but under 1% were transmitted to the national PV office within 48 h.
Conclusion Regular PV training and mentoring of HCPs were effective in enhancing passive safety surveillance in Malawi,
but the transmission of reports to the national PV centre requires further improvement.
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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 m...ake 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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Élément culturel important, les plantes ont été utilisées pendant des siècles par les populations pour se soigner. Cependant, peu d’ethnies connaissent leur pharmacopée de par le manque d’études ethnobotaniques. La présente étude, réalisée en pays San, entité territoriale traditionn...elle (Nord-Ouest du Burkina Faso), répond à ce souci de documenter les plantes médicinales. À travers une série d’enquêtes ethnobotaniques, 75 tradithérapeutes Sananont été interviewés. Les informations recherchées ont porté sur la plante, son nom local, ses parties utilisées, les pratiques médicales et les vertus thérapeutiques afférentes. Les résultats ont montré que 94 espèces végétales sont utilisées pour combattre différentes pathologies. Les feuilles (31 %), les racines (25 %) et les écorces du tronc (23 %) sont les principales parties utilisées pour préparer les recettes. Seules ou en association, ces parties interviennent dans l’élaboration des recettes par des procédés utilisant principalement la décoction (58 %), la trituration (17 %) et la macération aqueuse (11 %). Soixante-cinq pour cent (65 %) des produits obtenus sont administrés par voie orale via la boisson et les applications externes représentent 35 %. Treize catégories d’utilisation ont été recensées. Cependant, les tradipraticiens de santé sont en désaccord sur les thérapies proposées pour traiter ces catégories. La diversité des thérapies recensées en pays San, est une richesse culturelle. Ces données de la pharmacopée san sont une base pour une étude approfondie des aptitudes sylvicoles des plantes victimes de déracinement et la création de pépinières communautaires, afin de disposer de réservoirs de plantes médicinales proches des villages.
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