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On 26 Avril 2023, the European Commission put forward a 'pharmaceutical package' to revise the EU's pharmaceutical legislation and make medicines more available, accessible and affordable, while supporting the competitiveness and attractiveness of the EU pharmaceutical industry, with higher environmental standards. The package includes proposals for a new directive and a new regulation, which would replace the existing pharmaceutical legislation, including the legislation on medicines for children ...

During the first plenary session of October 2022, the European Parliament is expected to vote on two political agreements on proposals related to the European Health Union initiative: the proposed regulation on serious cross-border health threats (SCBHT), and the proposed regulation on extending the mandate of the European Centre for Disease Control (ECDC). Complementing the launch of the Health Emergency and Response Authority (HERA), and adoption of a renewed mandate for the European Medicines ...

The 75th World Health Assembly will take place in Geneva, Switzerland from 22 to 28 May 2022. The main topic is “Health for peace and peace for health”. It will discuss and treat matters focusing on four pillars, three of which contribute to the “triple billion targets”: Pillar 1: One billion more people benefiting from universal health coverage ; Pillar 2: One billion more people better protected from health emergencies ; Pillar 3: One billion more people enjoying better health and well-being ; ...

Plenary round-up – January 2022

Em síntese 21-01-2022

A solemn ceremony was held in Strasbourg to honour the Parliament's late President David Maria Sassoli, who died the previous week. Following this sad occasion, the main point on the agenda for the January 2022 plenary session was the already scheduled mid-term election of Parliament's President, 14 Vice-Presidents and 5 Quaestors. Parliament also debated the programme of activities of the French Council Presidency, with Emmanuel Macron, President of the French Republic.

As part of building a European Health Union, as well as in response to the Covid 19 pandemic, the European Commission proposed in November 2020 to reinforce the European Medicines Agency's role in crisis preparedness and the management of medicines and medical devices. The proposed regulation seeks to better anticipate possible shortages and to ensure timely development of high-quality medicinal solutions, to allow the EU to react to health crises more quickly, efficiently, and in a coordinated manner ...

The Analytical Study suggests that the seven EU agencies in the health and safety field demonstrate strong European added value and that this is widely recognised by Member States and other stakeholders including business. The agencies have played an important role in the COVID-19 pandemic. More generally. the study concludes that the cost of ‘non-agencies’, i.e. a situation where the agencies ceased to exist, would be higher to the European Commission, national authorities and business than the ...

On 11 November 2020, the European Commission adopted a proposal on serious cross-border threats to health. The proposed regulation aims to strengthen existing structures and mechanisms for better protection, prevention, preparedness and response against all health hazards at EU level. The European Parliament's Committee on the Environment, Public Health and Food Safety adopted its report on 13 July 2021. This is due to be voted during the September plenary session, thus setting Parliament's negotiating ...

On 11 November 2020, the European Commission adopted a proposal to bolster the mandate of the European Centre for Disease Prevention and Control (ECDC), with a view to improving the EU's capacity to anticipate, prepare for and manage future cross-border health threats. The European Parliament's Committee on the Environment, Public Health and Food Safety adopted its report on 29 June 2021. This is due to be voted during the September plenary session, thus setting Parliament's negotiating position ...

On 11 November 2020, the European Commission adopted a proposal to strengthen the European Medicines Agency (EMA). The proposed regulation would allow the EMA, among other things, to better anticipate possible shortages of medicinal products and ensure their timely development, with the aim of improving the EU's capacity to respond to health emergencies. The European Parliament's Committee on the Environment, Public Health and Food Safety adopted its report on 22 June 2021. This is due to be voted ...

The current drug development paradigm is too drug-centred and does not sufficiently take into account the patients that will receive the new therapy. This has led to the emergence of a research gap between the pre-approval development of medicines and their post-approval use in real-world conditions. In this study, semi-structured interviews were performed with experts in drug development process. It offer an overview concerning the concept of treatment optimisation and potential policy options.