Regulation (EU) 2017/745 on medical devices becomes applicable in the European Union. It aims to ensure the smooth functioning of the internal market as regards medical devices, for a high-level protection of health for patients and users.
CHMP at EMA has recommended granting an extension of indication for the COVID-19 vaccine Comirnaty® to include use in children aged 12 to 15.
The European Medicines Agency has launched a public call for scientific experts to express their interest in becoming members of its scientific advisory groups.
The manuscript “Ethical and procedural issues for applying researcher-driven multi-national paediatric clinical trials in and outside the European Union: the challenging experience of the DEEP project” has been published on the BMC Medical Ethics journal.
On February 2021, the European Data Protection Board (EDPB) released the Document on response to the request from the European Commission for clarifications on the consistent application of the GDPR, focusing on health research.
The European Commission granted a conditional marketing authorisation for the fourth COVID-19 vaccine, developed by Janssen Pharmaceutica NV.
The collaborative work “Paediatric clinical research in Europe: an insight on experts’ needs and perspectives”, developed within the Paediatric Clinical Research Infrastructure Network – PedCRIN project, was recently published on Contemporary Clinical Trials Communications journal.
The human medicines committee (CHMP) at the European Medicines Agency (EMA) has issued a reflection paper outlining the requirements for manufacturers planning to modify their COVID-19 vaccines in order to address SARS-CoV-2 variants.
In occasion of the Rare Disease Day 2021, Fondazione Gianni Benzi developed an informative material focused on rare diseases and COVID-19.
The article “Paediatric Medicines in Europe: The Paediatric Regulation—Is It Time for Reform?” was published on the journal Frontiers in Medicine – Regulatory Science.
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