Role
The Institute's main goal is to ensure the quality, safety and efficacy of medicines and the quality, safety and performance of health products in order to avoid the risks of their use while ensuring adequate standards of public health and consumer's protection.
Amongst Infarmed top activities the regulation and supervision of medicinal and health products from research up to their use by healthcare professionals and patients is of particular importance.
Infarmed performs at national and European levels its competences and responsibilities of National Competent Authority on medicines and health products and of Reference Laboratory on the Quality Control of Medicines within the scope of the Network of Official Medicines Control Laboratories (OMCL).
Activities
The Institute pursues its activity in several domains at national and at European levels:
- Research, evaluation and authorisation of medicines
- Quality, safety and efficacy control of medicines
- Good Clinical Practices (GCP's) in clinical trials
- Research, assessment, registration, monitoring and supervision of health products
- Clinical research evaluation, assessment and registration of CE marked medical devices, notification of health care products and market supervision activities
- Licensing and inspection of pharmaceutical activity
- Licensing, auditing and inspection of manufacturers, wholesalers and pharmacies ensuring the respect for the rules applicable to each operator namely Good Manufacturing Practices (GMP's), Good Distribution Practices (GDP's) and Good Pharmacy Practices (GPP's)
- Medicines and health products quality control
- Collecting medicines and health products samples along the whole circuit and their analytical control at Infarmed's laboratory
- Adverse Drug Reactions monitoring through pharmacovigilance, vigilance and monitoring of the use of health products
- Collecting and evaluating Adverse Drug Reactions or any other incidents that may occur with medical devices and any other information related with the usage of medicines and health products
- Supervision of the evolution of the market and promotion of the rational use of medicines including generics
- Evaluation of medicines for reimbursement purposes
- Evaluation of pharmaco-therapeutic and pharmaco-economic studies
- Monitoring of the access and use of medicines and health products
- Release of information to healthcare professionals and citizens with a view to promote the safe and rational use of medicines and other health products
- Release of information for various users through the web site of Infarmed and also through specific publications (such as the Therapeutic Handbook, the National Formulary of Medicines, the Guide of Generic Medicines, the Pharmacovigilance Bulletin, Infarmed Notícias Journal distributed to all partners)
- The Medicines Information Blue line (800 222 444)
- The Information Centre on Medicines and Health Products and the Technical and Scientific Documentation Centre
- Development of preventive and corrective actions on the Medicines Policy under implementation
Co-ordination on community and international affairs
Infarmed's role in international and European health
Infarmed plays a key role internationally, sharing its expertise in medicines and medical devices evaluation, clinical trials, authorisation, surveillance, licensing, health technology assessment and pricing and reimbursement.
Collaboration within the European system
As part of the European System for the Evaluation and Authorisation of Medicines and Health Products, Infarmed works with EU regulatory authorities to ensure product quality safety and efficacy. It is involved in key networks, including the European Network of Medicines and Medical Devices Authorities and the Network of Competent Authorities on Pricing and Reimbursement.
Infarmed is also a member of the Heads of HTA Agencies Group (HAG), responsible for increasing the convergence and cooperation of European Health Technology Assessment systems and to promote effective and efficient solutions for a European HTA collaboration, to enhance the impact of HTA in decision-making and on European healthcare systems.
Driving European health projects
Through the EU4HEALTH programme, Infarmed supports the EU priorities within the scope of pharmaceutical and medical devices legislation, clinical trial regulation, artificial intelligence, and inspections. These projects strengthen national authorities and prepare them for future challenges, including for new pharmaceutical regulations.
Global partnerships and cooperation
Globally, Infarmed collaborates with the European Medicines Agency (EMA) and other international organisations such as ICMRA to address global health challenges. It also partners with Portuguese-speaking and Ibero-American countries to share knowledge and best practices.
Infarmed is actively involved in the European project to establish the African Medicines Agency (AMA), working with Mozambique and Cape Verde to harmonise pharmaceutical regulations in the African Union and improve access to safe, high-quality medicines.
Infarmed remains committed to fostering international cooperation and advancing public health in the pharmaceutical and health products sector.
EMRN and Global Regulatory Cooperationn
INFARMED, I.P., as a participant in the European Medicines Regulatory Network (EMRN) embraces and actively supports cooperation with regulatory authorities in third countries. This collaboration aims to strengthen global regulatory systems, promote mutual reliance, and enhance public health worldwide.
For direct contact with other National Competent Authorities (NCAs) within the EMRN, please refer to the NCA Contact List on the HMA website.
Human resources
To fulfil its responsibilities in the various fields the Institute counts with 330 staff members of which more than 50 per cent has educational background on pharmaceutical and medical sciences amongst other scientific areas.
Infarmed relies likewise on a significant support of highly qualified experts from universities, hospitals and research centres. These professionals carry out their tasks in the Institute's several specialised technical committees as well as in external technical and scientific working groups, all totalling app. 150 experts.
Executive board
Rui Santos Ivo (President)
Raquel Ascenção (Vice-president)
Eduardo Costa (Member)
