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The COVID-19 pandemic highlighted the need for a resilient healthcare system but also for quick access to inventions and technologies in challenging situations. To address this need, in April 2023 the Commission submitted a proposal for a regulation on compulsory licensing for crisis management. The aim is to secure the rapid deployment of patent-protected inventions in times of crisis or emergency, without eroding patent protection as an incentive to innovate. The proposal lays down rules and procedures ...

The proposed revision of the EU's pharmaceutical framework covers the EU's general pharmaceutical legislation and the paediatric and orphan medicines regulations ('specific pharmaceutical legislation') in an integrated manner. The merger of the orphan and paediatric regulations with the legislation applicable to all medicinal products is explained with 'simplification and increased coherence' in the explanatory memorandum of the proposed directive. The proposed revision is supported by two impact ...

On 26 April 2023, the European Commission launched a revision of the EU's pharmaceutical legislation, including legislation on medicines for children and for rare diseases. Since the early 2000s, the EU legislative framework has provided a complex set of obligations, incentives and rewards to stimulate the development of medicines for children and for rare disease patients. Over the last 20 years, the EU legislation has led to the development of new medicines for these categories of patients. The ...

These proceedings summarise the presentations and discussions before the European Parliament’s Health Working Group as part of the workshop on ‘New incentives to improve the accessibility and availability of antimicrobial medicinal products’, held on 26 October 2022. The five presentations touched, inter alia, upon the burden of AMR, the current research on development of antimicrobials, and incentive models. These workshop proceedings were provided by the Policy Department for Economic, Scientific ...

The crisis caused by the coronavirus pandemic has, with tragic consequences, brought to the fore the fact that the European Union (EU) is dependent on non-EU sources for medical equipment such as personal protection equipment (including masks) and artificial respiratory equipment, as well as other products needed in the fight against the virus. In response to shortages, Member States have taken initiatives to produce and distribute medical equipment and the EU has put in place a number of coordinated ...

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.

Zdravila in medicinski pripomočki

Kratki vodnik po EU 01-11-2017

Ker za zdravila in medicinske pripomočke veljajo pravila enotnega trga, je za izdajo dovoljenj za te izdelke z njihovim ocenjevanjem in nadzorom pristojna Evropska unija. Zaradi varovanja javnega zdravja dovoljenje za nova zdravila za uporabo v humani medicini izda Evropska agencija za zdravila v skladu s centraliziranim postopkom in/ali nacionalne agencije na necentraliziran način. Dostop medicinskih pripomočkov do trga je treba urejati s podrobnim regulativnim okvirom, ki ga izvajajo organizacije ...

The European Medicines Agency (EMA) is a decentralised agency of the EU. Its mission is to foster scientific excellence in the evaluation and supervision of medicines in the Member States of the EU and the European Economic Area. The EMA began operating in London in 1995. In the context of the United Kingdom's withdrawal from the EU (Brexit), the EMA will have to move to another location that will be decided upon by common agreement among the remaining 27 Member States (EU-27). The criteria and the ...

Transatlantic regulatory patterns overall and in four key sectors: food, automobiles, chemicals, and pharmaceuticals indicate that the EU risk regulation is not always or generally more stringent or precautionary than the US regulation. In fact, the reality is a complex mix of parity and particularity. While there is overall EU-US similarity, there is also variation. In some risk matters, and across and within sectors, there is more precaution in Europe, whereas in others it may be in the US. Even ...

This report summarises the presentations and discussions of the Workshop on "The Paediatric Regulation: Are children still missing out on potentially life-saving treatments?" held at the European Parliament in Brussels, on Tuesday 16 June 2015. The aim of the workshop was to discuss the main challenges and future perspectives related to the treatment of children in Europe in view of a potential future revision of the Paediatric Regulation. The first part of the workshop discussed the state of play ...