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Physician Involvement in the Activities of the European Medicines Agency
Acta Médica Portuguesa, 2017 For more than two decades of activity, the European Medicines Agency has been operating as part of a network with the national medicines agencies in Europe, bringing together - in its various scientific committees and working groups - European experts on
Ivana Silva
doaj +7 more sources
Report of the European Medicines Agency Conference on RNA-Based Medicines
Nucleic Acid TherapeuticsRNA-based medicines have potential to treat a large variety of diseases, and research in the field is very dynamic. Proactively, The European Medicines Agency (EMA) organized a virtual conference on February 2, 2023 to promote the development of RNA-based medicines.
Anna Maria Gerdina Pasmooij +2 more
exaly +4 more sources
The European Medicines Agency’s goals for regulatory science to 2025 [PDF]
Nature Reviews Drug Discovery, 2019 It is increasingly important that regulatory agencies catalyse the translation of scientific and technological innovation into improved patient-centred health care. Here, we highlight the strategic goals of the European Medicines Agency to advance regulatory science and optimize the opportunities arising in areas such as cell and gene therapies, big ...
Philip A Hines, Richard H Guy
exaly +2 more sources
Frontiers in MedicineThe article shows that the input given by healthcare professionals (HCPs) adds value to the regulatory processes surrounding the development, authorisation, and monitoring of a medicine, but is also an instrument for accountability, trust, mutual ...
Ivana Silva +7 more
doaj +3 more sources
Performance of the accelerated assessment of the European Medicines Agency
British Journal of Clinical PharmacologyAbstract Aims In Europe, the European Medicines Agency (EMA) has an accelerated pathway to prioritize approval of medicines. Approved drugs are then assessed by Health Technology Assessment (HTA) bodies before being made available to patients.
Enrico Costa +2 more
exaly +3 more sources
Tuberculosis medicines for children in Europe: an unmet medical need
ERJ Open Research, 2023 The availability of first-line medicines for the treatment of drug-susceptible tuberculosis (TB) is inconsistent across European countries. This is particularly worrisome for child-friendly medicines.
Antonio Cherchi +4 more
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The Added Value of Patient Engagement in Early Dialogue at EMA: Scientific Advice as a Case Study
Frontiers in Medicine, 2022 The European Medicines Agency provides Scientific Advice to medicines developers and patient input has been an integral part of this process for many years.
Aisling Murphy +4 more
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What is the European Medicines Agency? [PDF]
Epidemiology and Psychiatric Sciences, 2012 In Europe, new medicines are approved or rejected on the basis of the results of studies carried out by the manufacturer and submitted to the European Medicines Agency (EMA). This article briefly presents the main roles and responsibilities of the EMA and the key rules that govern the approval process.
Bighelli, Irene, BARBUI, Corrado
openaire +3 more sources
Regulatory Standards in Orphan Medicinal Product Designation in the EU
Frontiers in Medicine, 2021 Twenty years of orphan regulation in Europe have now elapsed, with almost 2,400 orphan designated medicinal products and more than 190 orphan products authorised in the EU.
Stelios Tsigkos +7 more
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Frontiers in Medicine, 2022 In medicines development, the progress in science and technology is accelerating. Awareness of these developments and their associated challenges and opportunities is essential for medicines regulators and others to translate them into benefits for ...
Valentina Vignali +6 more
doaj +1 more source