The intent of these guidelines is to develop a holistic, coordinated, proactive and technology driven strategy for management of biological disasters through a culture of prevention, mitigation and preparedness to generate a prompt and effective response in the event of an emergency. Th
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e document contains comprehensive guidelines for preparedness activities, biosafety and biosecurity measures, capacity development, specialised health care and laboratory facilities, strengthening of the existing legislative/
regulatory framework, mental health support, response, rehabilitation and recovery, etc. It specifically lays down the approach for implementation of the guidelines by the central ministries/departments, states, districts and other stakeholders, in a time bound manner.
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Document No. : FDA/SMC/CTD/GL-CCT/2013/01
Guidance for the preparation and submission of dossiers
To understand the national situation, Ethiopia did a situation assessment, launched its first strategy in 2011, and took action to contain AMR, as detailed in the blue boxes found throughout this strategy. This updated version of the strategy was in
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response to the revised health and medicines policies, health sector transformation plan, and the resolutions of the 68th World Health Assembly
of May 2015 and so that Ethiopia’s efforts could be coordinated with global initiatives in the prevention and containment of AMR.
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The National pharmaceutical policy aligns itself to the Government vision for development of the health sector, as defined in Vision 2020, the Millennium Development Goals and the Economic Development for Poverty Reduction Strategy and the
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National Health Policy. The pharmacy policy addresses, among other challenges, the establishment of functional National Medicines Regulatory Authority that will implement all the regulatory functions, lack of local manufacturing facilities, lack of pricing policy of health commodities and technologies in private sector. This policy is based on the following key priorities: the Quality assurance, accessibility and the rational use of medicines, other health commodities and technologies.
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The safety of medicines in Zambia - why health workers need to take action | Produced by the National Pharmacovigilance Unit (NPVU)
This is the first NAP on the Prevention and Containment of AMR in Kenya. It has been developed based on the National Policy on Prevention and Containment of AMR and the recommendations of the situation analysis on AMR conducted in 2011 and updated i
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n 2016. This strategy provides a regulatory and implementation framework to establish and strengthen systems to contain the emergence and spread of AMR. Implementation of this strategy will require substantial funding and high-level political commitment. Because AMR is a multidisciplinary and intersectoral issue, successful implementation of this strategy will require effective coordination and collaboration among different sectors.
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Overcoming barriers in low- and middle-income countries
For the first time, this year’s report includes information on hepatitis C diagnostics. With a focus on selected countries with diverse HCV epidemics, the report provides updates on the various dimensions of access to HCV diagnostics and pha
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rmaceutical products, including product pricing, the regulatory environment and patent status, which together shape the national hepatitis response in different settings. It highlights key areas for action by ministries of health and other government decision-makers, pharmaceutical manufacturers and technical partners.
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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
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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 overall goal of the programme, to reduce the malaria morbidity and mortality by 75% (using 2012 as baseline) by the year 2020, continued to be pursued in 2014. The following areas were identified as some of the priorities for the year: Malaria Case Management under which we have Malaria in Pregn
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ancy (MIP), Home Based Care and Diagnostics.
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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
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authority of the Pharmaceutical Inspection Cooperation Scheme (jointly known as PIC/S). PIC/S aims to develop international standards between countries and pharmaceutical inspection
authorities, to provide harmonised and constructive co-operation in the field of GMP. PIC/S affiliation is subject to initial and periodic assessment of the participating authority to ensure that it has equivalent legislation, regulatory and enforcement procedures and inspection capacity.
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A series of tools and templates have been developed by WHO, FAO and OIE to accompany the manual for developing national action plans on antimicrobial resistance
This document has been developed as a guide to allinstitutions producing health care waste in planning and implementation of interventions that will reduce mismanagement of hazardous waste in Zambia.The National Health-Care Waste
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Management Plan for 2015 to 2019 provides an overview of the situation analysis, the proposed activities and the health care facility waste generating processes in Zambia and presents options for minimizing health-care waste generation through source reduction. The hazardous wastes generated by health care facilities are a challenge in Zambia as handling, storage, transportation and final disposal leaves much to be desired.
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Reporting system for the general public - This document aims to provide practical guidelines on how to set up national systems for consumers to report adverse reactions to medicines. The purpose is
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to help countries set up a well-organized and effective consumer reporting system within their pharmacovigilance centre. Throughout this document, the phrase “consumer reporting” is used to refer to reporting of adverse drug reactions (ADRs) by the general public.
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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 f
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ormulation of national and/or regional GACP guidelines and GACP monographs for medicinal plants and related standard operating procedures; and
3. encourage and support the sustainable cultivation and collection of medicinal plants of good quality in ways that respect and support the conservation of medicinal plants and the environment in general.
These guidelines concern the cultivation and collection of medicinal plants and include certain post-harvest operations.
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Doc. No.: INS/GDL/001-(Annexes)