17

Resultado(s)

Palavra(s)
Tipo de publicação
Domínio de intervenção
Autor
Palavra-chave
Data

European Medicines Agency: A look at its activities and the way ahead

10-07-2017

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 ...

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 decision-making process for selecting the new location were announced on 22 June 2017. Interested Member States have until 31 July 2017 to submit their offers. A decision is expected to be taken in November 2017. The EMA is governed by a management board and employs 897 staff (December 2016 figures). Its executive director is Guido Rasi. Around 89 % of the agency's budget comes from fees and charges levied for services rendered. Its scientific work is conducted in its scientific committees, working parties and other groups. Its main activities include: facilitating the development of and patient access to medicines; evaluating applications for marketing authorisations; monitoring the safety of medicines throughout their use in healthcare practice; and providing information to healthcare professionals, patients and the public.

Free Trade Agreements and Patterns of Risk Regulation in the EU and the US

13-09-2016

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 ...

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 if they are unusual deviations, and even if they go in both directions, transatlantic regulatory differences can still pose barriers to trade that may in some cases warrant harmonization. However, regulatory variation can also be the basis for learning to improve future regulatory design, both by comparing outcomes across regulations in different jurisdictions, and by planning adaptive regulation over time. International regulatory cooperation does not simply mean adopting the current standard of one side or the other. It can also involve collaboration to reviewing existing regulations and designing new approaches that improve outcomes for all.

The Paediatric Regulation: Are Children Still Missing Out on Potentially Life-Saving Treatments?

15-09-2015

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 ...

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 of the implementation of the Paediatric Regulation. The European Commission presented an overview of the findings of the 2013 Commission progress report on the Paediatric Regulation highlighting the remaining challenges. Some key problems, such as the difficulty to recruit quickly and to find a sufficient number of children patients to conduct clinical trials, were also presented from the industry perspective. The second part of the workshop focused on practical experiences and policy options for improved medicines for children. Still too often, children die from diseases which could be cured with the right treatments. All participants agreed that the Regulation provides a good basis, but that it needs further improvements and fine-tuning to ensure that children are not missing out on life-saving treatments. This workshop and the respective document were prepared by the Policy Department A at the request of the Committee on Environment, Public Health and Food Safety.

Autor externo

Olga SOLOMON, Magda CHLEBUS, Karen and Mr Kevin CAPEL and Andrea BIONDI

Medicinal products in the European Union: The legal framework for medicines for human use

01-04-2015

EU legislation on human medicines goes back 50 years. Its twofold aim is to safeguard public health without hindering development of the European pharmaceutical industry or trade in medicinal products. The regulatory framework is complex and covers the entire lifecycle of a medicine, from manufacture, to clinical trials, to marketing authorisation, to pharmacovigilance and patient information. Added to that, the principles of good manufacturing, distribution and pharmacovigilance practice contribute ...

EU legislation on human medicines goes back 50 years. Its twofold aim is to safeguard public health without hindering development of the European pharmaceutical industry or trade in medicinal products. The regulatory framework is complex and covers the entire lifecycle of a medicine, from manufacture, to clinical trials, to marketing authorisation, to pharmacovigilance and patient information. Added to that, the principles of good manufacturing, distribution and pharmacovigilance practice contribute to increasing medicines' safety. An emerging approach to granting early access to medicines – adaptive pathways – could prove its future merits for patients with a medical condition not adequately addressed by an existing therapy.

Control of drug precursors in the EU

17-10-2013

Trade in drug precursors is subject to strict controls at both international and EU level. Illicit drug producers manage however to "divert" these substances from legal trade, or replace them with substitutes, not yet controlled. Legislators try to keep pace with these developments, as illustrated by the recent Commission proposals to amend the 2004 and 2005 Regulations on drug precursors, due to be voted in plenary in October.

Trade in drug precursors is subject to strict controls at both international and EU level. Illicit drug producers manage however to "divert" these substances from legal trade, or replace them with substitutes, not yet controlled. Legislators try to keep pace with these developments, as illustrated by the recent Commission proposals to amend the 2004 and 2005 Regulations on drug precursors, due to be voted in plenary in October.

Disease Mongering (Pseudo-Disease Promotion)

15-11-2012

Disease mongering is the promotion of pseudo-diseases by the pharmaceutical industry aiming at economic benefit. Medical equipment manufacturers, insurance companies, doctors or patient groups may also use it for monetary gain or influence. It has increased in parallel with society's 'medicalisation' and the growth of the pharmaceutical complex. Due to massive investments in marketing and lobbying, ample use of internet and media, and the emergence of new markets, it is becoming a matter of concern ...

Disease mongering is the promotion of pseudo-diseases by the pharmaceutical industry aiming at economic benefit. Medical equipment manufacturers, insurance companies, doctors or patient groups may also use it for monetary gain or influence. It has increased in parallel with society's 'medicalisation' and the growth of the pharmaceutical complex. Due to massive investments in marketing and lobbying, ample use of internet and media, and the emergence of new markets, it is becoming a matter of concern, and policy makers should be aware of its perils and consequences.

ACTA - Anti-Counterfeiting Trade Agreement

29-06-2012

The Anti-Counterfeiting Trade Agreement (ACTA) is a plurilateral agreement between the EU, its Member States (MS) and ten other countries, including the USA and Japan.

The Anti-Counterfeiting Trade Agreement (ACTA) is a plurilateral agreement between the EU, its Member States (MS) and ten other countries, including the USA and Japan.

Palliative care in the European Union

24-06-2011

Palliative care is a holistic approach to problems faced by terminally ill patients, their families, and medical personnel working with them.

Palliative care is a holistic approach to problems faced by terminally ill patients, their families, and medical personnel working with them.

Diferenças nos custos e no acesso a produtos farmacêuticos na UE

15-03-2011

O presente relatório analisa as diferenças nos preços dos produtos farmacêuticos entre Estados- Membros. Apresenta uma visão geral dos preços de produtos farmacêuticos patenteados, bem como dos produtos farmacêuticos sem patente sujeitos à concorrência dos genéricos de preço inferior. O relatório analisa as abordagens utilizadas pelos Estados-Membros para regular o mercado farmacêutico tanto no domínio da procura como da oferta e avalia os dados relativos ao impacto das diferentes abordagens nos ...

O presente relatório analisa as diferenças nos preços dos produtos farmacêuticos entre Estados- Membros. Apresenta uma visão geral dos preços de produtos farmacêuticos patenteados, bem como dos produtos farmacêuticos sem patente sujeitos à concorrência dos genéricos de preço inferior. O relatório analisa as abordagens utilizadas pelos Estados-Membros para regular o mercado farmacêutico tanto no domínio da procura como da oferta e avalia os dados relativos ao impacto das diferentes abordagens nos preços dos produtos farmacêuticos, na contenção de custos e na inovação industrial. O relatório também considera as implicações que se geram no acesso dos doentes aos medicamentos. Considera ainda opções políticas destinadas a reforçar a coordenação entre Estados-Membros e o intercâmbio das melhores práticas.

Autor externo

Panos Kanavos, Sotiris Vandoros, Rachel Irwin, Elena Nicod and Margaret Casson (Medical Technology Research Group - LSE Health, London School of Economics and Political Science, study prepared under a framework contract held by Milieu Ltd.)

Note on the Pharmaceutical Package for the EP Information Offices (EPIOs)

16-08-2010

The Pharmaceutical Package in this document refers to the initiatives taken by the European Commission under the "Communication on the future of the single market in pharmaceuticals for human use", setting out the EC's vision for the sector. It comprises three pieces of legislation put forward to the European Parliament on different aspects of medicinal products. The proposals cover: information to patients on prescription medicines, pharmacovigilance, and patient safety and falsified medicines. ...

The Pharmaceutical Package in this document refers to the initiatives taken by the European Commission under the "Communication on the future of the single market in pharmaceuticals for human use", setting out the EC's vision for the sector. It comprises three pieces of legislation put forward to the European Parliament on different aspects of medicinal products. The proposals cover: information to patients on prescription medicines, pharmacovigilance, and patient safety and falsified medicines. These legislative proposals have a direct impact on public health, as well as connections with internal market and industrial policies. In the European Parliament the Committee on Environment, Public Health and Food Safety-ENVI is leading these reports. The committees on the Internal Market-IMCO and Industry, Research & Energy-ITRE are responsible for opinions. This note provides a general overview of the present situation on public health policy and pharmaceutical products in the EU, taking into account its degree of implementation and impact. The note presents the three proposals from a public health perspective with regards to their present state of advancement inside the legislative process. Finally it mentions the main stakeholders for these subjects. The note includes an annex with the key officials responsible for this policy area in the EU institutions. IP/

Futuros eventos

03-03-2020
Demographic Outlook for the EU in 2020: Understanding population trends in the EU
Outro evento -
EPRS
05-03-2020
Has the EU become a regulatory superpower? How it's rules are shaping global markets
Outro evento -
EPRS

Parceiros

Mantenha-se ligado

email update imageSistema de atualizações por correio eletrónico

O sistema de alerta por "e-mail", que remete as últimas informações diretamente para o seu endereço de correio eletrónico, permite-lhe acompanhar todas as pessoas e todos os eventos relacionados com o Parlamento Europeu, o que inclui as últimas notícias relativas aos deputados, aos serviços de informação ou ao Think Tank.

Pode aceder ao sistema de qualquer ponto da página eletrónica do Parlamento. Para se inscrever e receber notificações do Think Tank, basta comunicar o seu endereço de correio eletrónico, selecionar os temas do seu interesse, indicar a frequência (diária, semanal ou mensal) e confirmar o registo, clicando na hiperligação que receber por correio eletrónico.

RSS imageFluxos RSS

Não perca nenhuma informação ou atualização das páginas do Parlamento Europeu na Internet, utilizando o nosso fluxo RSS.

Clique na seguinte hiperligação para configurar o seu fluxo RSS.