[{"bbox": [99, 121, 1122, 253], "category": "Text", "text": "out the productions that will be used for clinical testing studies. The project will ensure the completion of the infrastructure and equipment of this complex for research and development operations to meet the demand for medicines and novel products from the Health System, in line with environmental practices in terms of preserving natural resources and preventing pollution. This industrial infrastructure will make it possible to develop the products to be used for clinical testing studies."}, {"bbox": [96, 262, 1133, 501], "category": "Text", "text": "**CECMED-Centre for State Control of Medicines, Equipment and Medical Devices:** it is the National Regulatory Authority (NRA), subordinated to the Ministry of Public Health, designated by the Cuban State to regulate and control medicinal products and medical devices for human use subject to health surveillance. It has the task of promoting and protecting the health of the population through an effective and transparent health regulation, control and surveillance system, ensuring medicines, medical equipment and devices, services and other health products with safety, effectiveness and quality. Through this project, the infrastructure of the CECMED National Control Laboratory will be completed, the information and communications infrastructure will be upgraded and the development of technical exchange between regulatory agencies will be promoted with a view to preparing for the WHO regulatory systems assessment process."}, {"bbox": [96, 510, 1133, 588], "category": "Text", "text": "**University of Havana:** it is attached to the Ministry of Higher Education and hosts 400 research projects, 71 international projects including 3 Horizon 2020 projects. It has an excellent talent with teaching, scientific and innovative skills."}, {"bbox": [96, 591, 1133, 645], "category": "Text", "text": "**Agencies of the Member States:** AFD is engaged in lending operations in the sector and planning new operations with shared objectives with the present action, which will be considered for EFSD+ operations."}, {"bbox": [96, 656, 1133, 711], "category": "Text", "text": "**International and regional organizations (PAHO/WHO/UNDP):** these actors will be key to ensuring policy coherence with international standards, timely delivery of equipment and effective transfer of knowledge."}, {"bbox": [96, 725, 903, 753], "category": "Text", "text": "**Private sector companies in the European Union:** potential participants in joint ventures."}, {"bbox": [96, 766, 1133, 820], "category": "Text", "text": "**Cuban SMEs:** the participation of Cuban SMEs in this project will be encouraged, seeking synergies with the action under the EU-Cuba MIP 2021-2027 to support new economic actors."}, {"bbox": [96, 828, 1133, 909], "category": "Text", "text": "Other actors included in this action are the Ministry of Higher Education (MES), with its network of universities, the Ministry of Foreign Trade and Investment (MINCEX), BioCubaFarma, the Ministry of Public Health (MINSAP) and centres such as Instituto Pedro Kouri³, and the Institute for Hygiene and Epidemiology (INHEM)."}, {"bbox": [96, 935, 1133, 1039], "category": "Text", "text": "In addition, this action will be developed in synergy with the ongoing EU programmes in Cuba supporting the biotechnology and health sector, in particular with the LAIF programme supporting MINSAP and the network of SUMA laboratories. As already mentioned, synergy will be ensured with the programmes under the EU-Cuba MIP 2021-2027."}, {"bbox": [86, 1082, 604, 1114], "category": "Section-header", "text": "# 3 DESCRIPTION OF THE ACTION"}, {"bbox": [144, 1148, 557, 1179], "category": "Section-header", "text": "## 3.1 Objectives and expected outputs"}, {"bbox": [96, 1194, 1133, 1248], "category": "Text", "text": "The **Overall Objective (Impact)** of this action is to strengthen capacities for the development, production, approval and control of relevant, safe and effective biotechnological products."}, {"bbox": [96, 1264, 647, 1292], "category": "Text", "text": "The **Specific(s) Objective(s) (Outcomes)** of this action are:"}, {"bbox": [135, 1293, 1133, 1368], "category": "List-item", "text": "1. To increase research, development, and production of biotechnological products and Active Pharmaceutical Ingredients (APIs), and its potential distribution through multilateral mechanisms such as COVAX."}, {"bbox": [135, 1372, 1133, 1424], "category": "List-item", "text": "2. To reinforce the National Regulatory Agency (NRA), CECMED, in its regulatory role and in monitoring the safety and efficacy of biotechnological products, according to international standards."}, {"bbox": [135, 1425, 1133, 1479], "category": "List-item", "text": "3. To create new opportunities for biotechnological scientific cooperation between EU and Cuba (international scientific project management, public procurement competences, etc)."}, {"bbox": [96, 1504, 1133, 1558], "category": "Text", "text": "The **Outputs** to be delivered by this action contributing to the corresponding Specific Objectives (Outcomes) are contributing to:"}, {"bbox": [86, 1621, 362, 1646], "category": "Footnote", "text": "³ Institute of Tropical Medicine"}, {"bbox": [1038, 1681, 1143, 1705], "category": "Page-footer", "text": "Page 6 of 24"}]