EMA and the national competent authorities (NCAs) in EU Member States have prepared a safety monitoring plan for COVID-19 vaccines. The plan outlines how relevant new information emerging after the authorisation and uptake of COVID-19 vaccines in the pandemic situation will be collected and promptly reviewed.
Five new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended five medicines for approval at its November 2020 meeting. The Committee recommended granting a marketing authorisation for Phesgo (pertuzumab / trastuzumab) for the treatment of early and metastatic breast cancer. The CHMP adopted a positive opinion for Roclanda (latanoprost / netarsudil) for the reduction of elevated intraocular […]
Today is my last day as Executive Director of EMA. My mandate comes to an end in the middle of the biggest public health emergency in a century.
EFSA’s animal health specialists have contributed to a rapid assessment of the risks to human health from the new SARS-CoV-2 variants related to mink.
EFSA’s existing guidelines for the risk assessment of genetically modified animals are adequate for evaluating risks associated with gene drive modified insects. However, further guidance is needed for some areas, such as molecular characterisation, environmental risk assessment and post-market environmental monitoring, say EFSA’s experts on Genetically Modified Organisms.
At least 74 migrants have died after the ship carrying them was wrecked off the coast of Libya, the UN says.
The European Commission’s reporting on how well the EU spending programmes perform shows mixed results, according to a new report published today by the European Court of Auditors (ECA). While the auditors welcome the fact that the reporting keeps improving and is becoming more balanced, they also point to a number of problems: the quality […]
A number of European countries have warned that it is too early to plan for Christmas travel, as coronavirus cases continue to rise across the continent.
The city of Nuremberg has opted to conserve the infamous Nazi party rally grounds after decades of debate over whether to preserve the site.
In September 2020, the European Food Safety Authority (EFSA) facilitated an online workshop on crisis preparedness and procedures with Members and Observers of EFSA’s Focal Point Network. The overall aims of the event were, in the context of a food or feed safety incident,(i) to establish the most appropriate ways to improve collaboration—and exchange data […]
