European Medicines Agency (EMA)

Supply of more than 100 drugs could be disrupted by Brexit

More than 100 medicinal products could be at risk of supply if marketing authorisation holders do not make the necessary changes to their marketing authorisations in time for Brexit, according to a survey from the European Medicines Agency.…

First CAR-T cancer therapies recommended for approval

The European Medicines Agency has recommended two marketing authorisations for chimeric antigen receptor T-cell medicines in the EU for the first time.…

First monoclonal antibody for migraine recommended for approval by EMA

The European Medicines Agency has recommended granting a marketing authorisation for erenumab for migraine prevention.…

Milan challenges EMA move to Amsterdam

The city of Milan is continuing to challenge the decision to relocate the European Medicines Agency’s headquarters from London to Amsterdam post-Brexit.…

EMA committee maintains recommendation to suspend hydroxyethyl-starch solutions for infusion

The EMA’s Pharmacovigilance Risk Assessment Committee has confirmed its recommendation to suspend hydroxyethyl-starch solutions for infusion in the European Union.…

EMA committee starts review of methotrexate dosing errors

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee has started a review of the risk of dosing errors with methotrexate medicines, which are used to treat cancers and various inflammatory conditions.…

MHRA will lose EMA work before Brexit transition period

The UK will lose its involvement in evaluating medicines for the European Medicines Agency from the date it formally leaves the European Union in March 2019, despite plans for the UK to remain closely tied to the EU during a transition period lasting until the end of 2020.…

EMA recommends six medicines for approval

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended six medicines for approval, including two biosimilars and one orphan medicine.…

EMA endorses strengthened regulatory measures for valproate

The European Medicines Agency’s Coordination Group for Mutual Recognition and Decentralised Procedures — Human has endorsed strengthened measures to avoid valproate exposure during pregnancy.…

EMA to hold public hearing on quinolone and fluoroquinolone antibiotic safety

The European Medicines Agency (EMA) has announced that its Pharmacovigilance Risk Assessment Committee will hold a public hearing on quinolone and fluoroquinolone antibiotics, as part of an ongoing safety review into the drugs.…