EMA and EU medicines regulatory agencies agree on joint strategy until 2028
EMA and the Heads of Medicines Agencies (HMA) have published their joint EU medicines agencies’ network strategy to 2028 (EMANS),…
EMA: New clinical trial map launched in the EU
A new clinical trial map is now accessible from the public website of the Clinical Trials Information System (CTIS). The…
One Health Task Force: ECDC hosts cross-agency workshop on stakeholder engagement
The workshop brought together the five agencies of the Task Force – the ECDC, the European Food Safety Authority (EFSA),…
EMA establishes regular scientific advice on certain high-risk medical devices
The European Medicines Agency (EMA) and the EU Commission have established a standard procedure for manufacturers of certain high-risk medical…
EMA recommended 114 new medicines and 46 new active substances for approval in 2024
The Agency recommended, among others, the first medicine to treat early Alzheimer’s disease, the first needle-free and smaller form of…
EMA publishes revised rules on handling of competing interests
The European Medicines Agency (EMA) has published the revised version of its policies on the handling of competing interests of…
EU Medicines Agency on new EU rules for health technology assessments
The regulation is an important step forward in accelerating and widening access to new medicines. In the European Union (EU),…
European Shortages Monitoring Platform enables better monitoring of shortages in the EU
The European Shortages Monitoring Platform (ESMP) has gone live with a core set of functionalities. Using this first version of…
EMA issues recommendation of Leqembi for treatment of early Alzheimer’s disease
The human medicines committee (CHMP) at the European Medicines Agency concluded that, in the restricted population assessed, the benefits of…
EMA: Use of opioids with weight loss medicine Mysimba may lead to serious side effects
Opioid medicines may not work effectively in patients taking Mysimba, because one of the active substances in Mysimba, naltrexone, blocks the effects…
EU Auditors: EU medical agencies need a booster to prepare for the next pandemic
The health crisis caused by the COVID-19 pandemic caught the EU partially off guard. Even though the two EU medical…
Common respiratory virus: EU Commission authorises mRNA vaccine
The EU Commission has authorised the mRNA vaccine ‘mResvia', to immunise adults over 60 years of age against lower respiratory tract disease, which…