Europe – Health Technology Assessment : Guidance on outcomes for joint clinical assessments
Clinical outcome assessments (COAs), used in clinical studies (whether they are interventional (also called experimental), or observational), are a key component of health technology...
Europe – Faster access to clinical trial information in Europe
The launch of a new version of the Clinical Trials Information System (CTIS) will allow earlier and more efficient access to information about clinical trials in the European...
Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 June 2024
Review of painkiller metamizole started
Review will look into risk of agranulocytosis, a sudden drop in white blood cells that can lead to serious infections,...
Europe – Two new advice pilots to improve clinical trials in Europe
The Accelerating Clinical Trials in the EU (ACT EU) initiative is today launching two advice pilots aimed at improving the quality of applications for clinical trials, the...
Europe – Annual report 2023
The Management Board’s oversight role covers the full range of EMA programmes and activities, making sure that the Agency works effectively and co-operates successfully...
Europe – Procedural advice on paediatric applications
The Paediatric Regulation came into force in the European Union (EU) on 26 January 2007. Its objective is to improve the health of children...
UK – New restrictions on puberty blockers
The government has today introduced regulations to restrict the prescribing and supply of puberty-suppressing hormones, known as ‘puberty blockers’, to children and young people under 18 in...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
EMA’s human medicines committee (CHMP) recommended 14 medicines for approval at its May 2024 meeting.
The CHMP recommended granting a marketing authorisation under exceptional circumstances for Adzynma* (rADAMTS13) an enzyme replacement therapy indicated...
Europe – First vaccine to protect adults from Chikungunya
EMA has recommended granting a marketing authorisation in the European Union (EU) for Ixchiq, the first vaccine in the EU to protect adults 18 years and...
Europe – New gene therapy treatment for haemophilia B
EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Durveqtix (fidanacogene elaparvovec) to treat severe and moderately severe haemophilia B in...
