selection

health legislation

This tag is associated with 4 posts

Medical devices and in vitro diagnostic medical devices [Plenary Podcast]

Written by Nicole Scholz, The current EU approval system for medical devices (MDs) and in vitro diagnostic medical devices (IVDs) is based on conformity assessment by ‘notified bodies’. A number of scandals stressed the need to tighten the regulatory framework for such devices. The European Commission’s proposals for regulations on MDs and IVDs, being discussed … Continue reading

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

Written by Nicole Scholz A high level of protection for human health is a central objective of European Union (EU) public health policy. To guarantee this objective, high standards of quality and safety for medicinal products are essential. Although pharmaceuticals are primarily regulated at the national level by the Member States, there is a large body of EU legislation … Continue reading

Essais cliniques: révision de la réglementation: Simplifier tout en maintenant la sûreté et la sécurité

La révision de la réglementation européenne sur les essais cliniques était attendue par toutes les parties intéressées. Elle conclut un processus d’évaluation de la directive 2001/20/CE, mené par la Commission à travers des consultations auxquelles la plupart des acteurs des essais cliniques (médecins, patients, industrie, organes de recherche) ont contribué. L’objectif de la proposition de … Continue reading

Financing and providing long-term care: The challenge of an ageing population

Older people are not the only people in need of long-term care (LTC), but in terms of numbers, they represent the greatest need. As more people live longer, the demand for LTC in Europe is expected to increase significantly. Paying for and providing quality care will be important challenges as the proportion of the population … Continue reading

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