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...
Europe – Commission approves up to €1 billion of State aid by six Member...
The European Commission has approved, under EU State aid rules, the first Important Project of Common European Interest (‘IPCEI') to support research, innovation and...
Europe – Commission facilitates faster access to medicines with clear rules for joint clinical...
Today, the European Commission adopted new rules for the joint clinical assessments of medicines at Union level, contributing to faster access to medicines for...
Europe – EMA revises Q&A guidance on drug-device combination products
The European Medicines Agency and the Co-ordination Group for Mutual Recognition and Decentralized Procedures (CMDh) have issued a revised guidance that clarifies the information...
Europe – EMA confirms recommendation for non-renewal of authorisation of Duchenne muscular dystrophy medicine...
Update as of 21 May 2024
The European Commission has asked the CHMP to review its January opinion on the renewal of the marketing authorisation for Translarna. The CHMP will now consider the...
Europe – Hydroxyprogesterone caproate medicines to be suspended from the EU market
EMA’s safety committee, PRAC, has recommended the suspension of the marketing authorisations for medicines containing 17-hydroxyprogesterone caproate (17-OHPC) in the European Union (EU). A review by the PRAC concluded...
