Sector Specific Documents

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Browsing Sector Specific Documents by Author "East African Community"

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    2nd EAC Regional Pharmaceutical Manufacturing Plan of Action 2017–2027:
    (EAC Secretariat, 2018) East African Community
    There is abundant interest on the part of the EAC Partner States in promoting their pharmaceutical industry. The first EAC Regional Pharmaceutical Manufacturing Plan of Action (EAC-RPMPOA): 2012–2016 provided the framework upon which regional and national strategies were aligned in an effort to strengthen the sector. While the implementation of the first plan has achieved several key milestones and contributed to the positive development of the sector, there is need for continuation and further improvement. The current plan (EAC-RPMPOA: 2017–2027) has been developed to build on the achievements and to set out new strategic approaches to surmount the challenges and capitalise on emerging opportunities within the sector. Key findings from this report show that while EAC pharmaceutical markets are growing rapidly, there is still a high dependency on imported pharmaceutical products and local firms are producing below capacity. Local manufacturers are strongly present in the anti-infectives product category but they miss out in immunological and cardiovascular markets, which have a large market share in the region. Even though locally produced medicines cover 66% of disease conditions, the region lacks the capacity to manufacture advanced formulations. This is attributable to a skills gap in the areas of product development and formulation expertise. Furthermore, there is a lack of appropriate and affordable financing for the sector, with options being limited to short-term loans with high interest rates. From the trade perspective, enhanced cooperation and harmonisation would reduce regulatory barriers and broaden export markets.
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    Aflatoxins:
    (East African Community, 2018-04) East African Community
    In the EAC Region, food crops and their products that are produced, consumed or traded in large quantities with high degree of susceptibility to aflatoxin include maize, groundnuts, cashew, and sesame. The potential economic and trade-related impacts of aflatoxin contaminated products in domestic and international markets can be significant. The contribution of market losses to the total economic impact depends on the extent to which the domestic market differentiates aflatoxin-contaminated products. If the domestic market does not differentiate aflatoxin-contaminated products, the market losses from the contamination will be minimal. Among EAC Partner States, in Kenya, the awareness about aflatoxins is high, signaling that domestic market impact will be higher than in other countries.
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    Africa agriculture transformation scorecard:
    (East African Community, 2018-06) East African Community
    Africa agriculture transformation scorecard: performance and lessons for East African Community
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    Agriculture and food security programmes
    (East African Community, 2020) East African Community
    The economies and livelihoods of citizens in East Africa are predominantly dependent on agriculture. The sector accounts for 25%-40% of EAC Partner States (Kenya, Uganda, Tanzania, Rwanda, Burundi and Republic of South Sudan) Gross Domestic Product and is a leading employer for over 80 percent of the population in the region. More than 70% of the industries in the EAC are agro-based and depend on agriculture as the main source of raw materials. Agricultural commodities constitute about 65% of the volume of intra-regional trade in the EAC.
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    Application form for a mutual recognition application for the registration of veterinary pharmaceutical product(s) in the East African Community
    (East African Community, 2019) East African Community
    Application form for a mutual recognition application for the registration of veterinary pharmaceutical product(s) in the East African Community
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    Application form for a mutual recognition procedure for the registration of immunological veterinary product(s) in the East Africa region
    (East African Community, 2021) East African Community
    Application form for a mutual recognition procedure for the registration of immunological veterinary product(s) in the East Africa region
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    Application form for a pre-submission meeting for the registration of veterinary medicinal product(s) in the East African region
    (East African Community, 2016) East African Community
    Application form for a pre-submission meeting for the registration of veterinary medicinal product(s) in the East African region
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    Application form for a repeat use mutual recognition procedure for a veterinary immunological product registered through a mutual recognition procedure in the East African Community
    (East African Community, 2021) East African Community
    Application form for a repeat use mutual recognition procedure for a veterinary immunological product registered through a mutual recognition procedure in the East African Community
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    Application form for a variation to a marketing authorization for a pharmaceutical veterinary product issued through EAC MRP
    (East African Community, 2021) East African Community
    Application form for a variation to a marketing authorization for a pharmaceutical veterinary product issued through EAC MRP
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    Application form for a variation to the marketing authorization of an immunological veterinary product registered through the EAC mutual recognition procedure
    (East African Community, 2021) East African Community
    Application form for a variation to the marketing authorization of an immunological veterinary product registered through the EAC mutual recognition procedure
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    Application form for GMP inspection of veterinary medicinal products using mutual recognition processes in the East African Region
    (East African Community, 2021) East African Community
    Application form for GMP inspection of veterinary medicinal products using mutual recognition processes in the East African Region
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    Best practice guide for mutual recognition procedures for the registration of veterinary medicinal product(s) in the East African region
    (East African Community, 2021) East African Community
    Following the adoption of the Mutual Recognition Procedure (MRP) by the East African Community (EAC) and subsequent constitution of the EAC-Technical Working Group and the Coordination Group for Mutual Recognition (CGMR), a new Mutual Recognition Procedure has been created. If an applicant wishes to have a Marketing Authorization (MA) granted in more than one Partner State, then the Applicant will have to use a Mutual Recognition Procedure (MRP). Two types of MRP are possible. One is where an Applicant already holds a Marketing authorization in one or more Partner States and wishes to have this recognized in other Partner States. The second type is where an Applicant applies for Marketing Authorizations for a new product in several Partner States simultaneously
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    Check list for the pre-submission meeting for the registration of veterinary medicinal product(s) in the East African region
    (East African Community, 2016) East African Community
    Check list for the pre-submission meeting for the registration of veterinary medicinal product(s) in the East African region
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    Climate change strategy (2011-2016)
    (EAC Secretariat, 2011) East African Community
    Climate change is contemporarily the most important global environmental, social and economic challenge, predicted to have severe impacts on a planetary scale. The adverse impacts of climate change on environment, human health, food security, human settlements, economic activities, natural resources, and physical infrastructure are already noticeable world-wide. Global warming is the most stricking indication of the pronounced Climate Change issue. It is the most direct effect of the increased trapping of heat radiation. Climate science has a firm basis in physics and is supported by a wealth of evidence from real world observations. The Reports of IPCC represent the best consensus to-date on the Climate Change agenda. The Fourth Assessment Report (AR4) of the IPCC, completed in November 2007, finds with more than 90% probability that human action is implicated in today’s climate change, and presents the already observed and projected impacts it will give rise to. It is certain that increased greenhouse gas emissions from the burning of fossil fuels and from land use change lead to a warming of climate, and it is very likely that these greenhouse gases are the dominant cause of the global warming that has been taking place since the industrial revolution.
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    Controlling the burden of liver disease through integrating hepatitis A and B vaccination into the national immunization programs of the EAC partner states
    (East African Community, 2018-04) East African Community
    Liver cancer is a leading cause of deaths in the world. Chronic hepatitis B infection causes 80 percent of liver cancer cases in the EAC region. The combination of aflatoxin exposure with hepatitis infection especially among people, who are malnourished or living with HIV results in a double-disease burden that increases disease severity, reduces survivability and heightens liver cancer prevalence. The economic losses to residents of all EAC partner states associated with morbidity and mortality from aflatoxin-attributable liver cancer is of a high magnitude. There is an urgent need to prioritize the prevention of Hepatitis A and B infections by administration of immunizations for all age group in the EAC Partner States.
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    Disposal and alternative use of aflatoxin contaminated food
    (East African Community, 2018-04) East African Community
    Agricultural commodities, including maize, groundnuts, and cassava, milk, and cotton seed contaminated with aflatoxin pose serious threat to human and animal health, and to the economies of the EAC Partner States. It is, therefore, desirable that contamination should be prevented to the greatest extent possible. Given that eradication of aflatoxin contamination in foods is not feasible at the moment, alternative uses should be considered with disposal being the last resort. The EAC, however, doesn’t have established and functional mechanisms for disposal of aflatoxin-contaminated agricultural commodities.
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    Draft declaration of the 12th summit of EAC heads of state on food security and climate change
    (East African Community, 2010) East African Community
    Draft declaration of the 12th summit of EAC heads of state on food security and climate change
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    Draft EAC trade and investment report 2016:
    (EAC Secretariat, 2017) East African Community
    The East African Community (EAC) consists of five countries namely; Burundi, Kenya, Rwanda, Tanzania and Uganda. South Sudan was admitted to the EAC in 2016. The EAC has a population of about 168.2 million with a combined GDP of US$155.2 Billion. As one of the fastest growing regional integration, growth in the EAC was driven by a growing manufacturing sector characterised by industrial development in all the five countries as well as a buoyant services sector especially construction, tourism and financial services. EAC is one of the leading exporters of agricultural commodities including cotton, coffee and fish and discovered significant amounts of extractives resources including oil, gas, high value minerals and abundant renewable energy generation potential.
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    Draft East African Community fertilizer policy
    (East African Community, 2021) East African Community
    The East African Community (EAC) Fertilizer Policy has been developed following the Council of Ministers’ Directive, and the EAC Regulatory Framework and Procedures for fertilizer marketing validated and adopted during the 7th EAC Sectoral Council of Ministers of Agriculture, Livestock, Fisheries and Food Security, in Kigali on 5th September 2014. It guides the development of legal instruments, strategies, programmes, and projects in the fertilizer industry in the realization of the overall objective of the EAC within the agricultural sector, to achieve food security and rational agricultural production, in tandem with the EAC Treaty and the EAC Agriculture and Rural Development Policy and Strategy. Further, Article 45. 3 (c) and (m) of the EAC Common Market Protocol promotes cooperation in production, availability and distribution of quality farm inputs in sufficient quantities in the Partner States. This calls for harmonized quality and standards of inputs, which includes fertilizer. The agricultural sector contributes heavily to the livelihoods, growth, and development of the six EAC Partner States, providing food, employment, and incomes to the population. The success of agricultural productivity relies substantially on agricultural inputs, of which fertilizer is key. The coordinated efforts of the EAC Partner States create market advantages that could be leveraged for the development of the fertilizer industry in the region and the ultimate benefit of smallholder farmers. The EAC Fertilizer Policy is, therefore, a strategic move by the EAC Partner States to achieve the goals of the EAC Treaty and the EAC Agriculture and Rural Development Policy and Strategy by anchoring the benefits that come with regional integration and harmonization. The Policy is organized in six sections. Section one contains background information on the situational analysis of the fertilizer industry and policy reforms that have been undertaken at the continental, regional, and Partner State levels relevant to the development of the fertilizer industry in the region. Section two describes the rationale and justification for the formulation of the Policy. Section three describes the goal and objectives of the Policy. Section four spells out the guiding principles by which the Policy and any of the instruments made under it will be directed. Section five details the policy statements. Finally, section six covers implementation and financial arrangements, outlines the roles of stakeholders, and describes the monitoring, coordination, and evaluation mechanisms, along with review of the Policy.
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    Draft harmonized criteria for registration and certification of processed and pre-packaged food for Intra-East African Community (EAC) trade
    (East African Community, 2020) East African Community
    The East African Community (EAC) has developed a Framework for facilitating cross border trade in food and cosmetic products. The framework aims to enhance intra-EAC trade in processed and pre-packaged foods and cosmetics products without medicinal claims by removing or minimising the impediments / non-tariff barriers (NTBs) created by standards, technical regulations and conformity assessment. The EAC Standardization, Quality Assurance, Metrology and Testing (SQMT) and Sanitary and Phytosanitary (SPS) frameworks provide for development and harmonization of procedures, guidelines and frameworks to enhance efficiency and effectiveness in achieving product safety and quality for consumer protection, as well as trade facilitation. The EAC has developed and harmonized a number of standards that have been adopted and implemented by Partner States in their food control systems and for trade facilitation. The EAC Partner States also recognize results of their respective conformity assessment processes among their respective National Standards Bodies (NSBs) whereby goods certified by the NSB of one Partner State are recognized as meeting quality and safety requirements and move freely across the borders.