[{"bbox": [97, 134, 1132, 215], "category": "Text", "text": "This action will help to meet global quality standards and regulatory requirements to ensure quality, safety and efficacy of biotechnological products; leverage alliances with EU companies and financing towards scaled up production; boost research, technology transfer and innovation."}, {"bbox": [97, 226, 1132, 304], "category": "Text", "text": "The action is in line with the EU's gender priorities and in particular with the Gender Action Plan III (2021-2025) regarding its thematic area of engagement \"Promoting economic and social rights and empowering girls and women\"."}, {"bbox": [145, 322, 390, 352], "category": "Section-header", "text": "## 2.2 Problem analysis"}, {"bbox": [97, 367, 1132, 471], "category": "Text", "text": "In Cuba, despite the achievements in the fields of biotechnology, there are elements that require further progress, such as the development of international scientific cooperation and the increase of R&D capacities, production and regulation of medicines and vaccines, as well as the modernisation of information and communications infrastructure."}, {"bbox": [97, 482, 1132, 748], "category": "Text", "text": "The Research and Development Unit of the Biotech Industrial Complex CIGB-Mariel was set up with the aim of expanding the production capacities of the Centre for Genetic Engineering and Biotechnology (CIGB) designed for the production of pharmaceutical ingredients. The infrastructure related to premises, climate system, critical systems, electricity and the rest of the ancillary services are installed and ready to start operation. However, at this point in time, the equipment infrastructure is in an incomplete state hence the opportunity of this project to complete the missing elements which will enable to start producing the various products ready to start clinical studies. The basic missing equipment consist of fermenters, tanks, units of Limlete in Situ, Homogenizers, tubular centralists, tangential filtration equipment, low-pressure chromatography units, freezers, laboratory equipment for processing control, different formulation lines for filling final products or drugs (bulbs, suppositories, and small lyophiser, among others)."}, {"bbox": [97, 757, 1132, 1021], "category": "Text", "text": "CECMED has an international recognition that places it on the WHO Transition List of the new Regulatory Systems Assessment Process and has until 2027 (5 years) to pass the evaluation process to become a WHO listed Authority, the highest international recognition in this area. To achieve this objective, work is carried out on the basis of established assessment indicators, identifying as priorities the completion of the analytical capacities of the National Control Laboratory for pre-qualification by WHO, the strengthening of its communications infrastructure and the development of its human resources as preparation for the assessment process through scientific and technical exchange with its peers and the strengthening of the regulatory dialogue between international actors such as EMA and other agencies, allowing confidence building to facilitate regulatory approval of priority medical products, especially those intended to respond to health emergencies, such as COVID-19."}, {"bbox": [97, 1033, 1132, 1246], "category": "Text", "text": "Moreover, although Cuba has experience in carrying out research and development projects, there is insufficient staff trained to manage and implement them and disseminate them through international impact journals. The University of Havana as a training centre has the capacity to develop training programmes on these topics with links with national and international experts. Therefore, in order to increase these capabilities, it is essential to have a technological infrastructure to facilitate the training of professionals and exchange with experts. Capacity building requires parallel actions in the training of professionals who are part of the entities involved in the project. In addition, training is required for the use of the new technologies installed and computing resources, as well as for the development of new analytical methodologies and the use of assessment tools."}, {"bbox": [97, 1255, 1132, 1441], "category": "Text", "text": "Cuba has a track record of highly successful prevention measures against infectious diseases and the implementation of research and production of competitive biotechnology at international level. The articulation of Cuban and European Union institutions and SMEs with a strong public health and research programme could benefit the people of both regions in urgent matters of global health and pandemic prevention. This will specifically include disease surveillance, ecosystem health and treatment research. This requires the development of an epidemiological intelligence system to monitor the health situation, risks, endemic and emerging diseases and thus inform relevant strategies in prevention, alert status, treatment and response to future health challenges."}, {"bbox": [85, 1483, 1142, 1539], "category": "Text", "text": "Identification of main stakeholders and corresponding institutional and/or organisational issues (mandates, potential roles, and capacities) to be covered by the action:"}, {"bbox": [97, 1558, 1121, 1639], "category": "Text", "text": "CIGB-Mariel Biotech Industrial Complex: it is a productive entity that has been designed and built to further develop Cuban biotechnological sector. It has production facilities based on active principles, formulation and filling, product packaging and production support areas. It also has a Research and Development Unit to carry"}, {"bbox": [1038, 1681, 1143, 1705], "category": "Page-footer", "text": "Page 5 of 24"}]