Europe – High-quality data to empower data-driven medicines regulation in the European Union
EMA and the Heads of Medicines Agencies (HMA) in the EU Member States are moving ahead with their ambitious agenda to increase access and improve the...
Europe – EMA Management Board: highlights of October 2022 meeting
COVID-19
At its 6 October 2022 meeting in Amsterdam, the European Medicines Agency (EMA) Management Board heard an update on the recent activities related to...
UK – Bristol Myers Squibb’s active ulcerative colitis treatment bags NICE recommendation
The recommendation is specifically for patients who are intolerant of, or whose condition has had an inadequate response, or loss of response to previous...
UK – European Commission Decision Reliance Procedure (EC DRP) extension
European Commission Decision Reliance Procedure has been extended by 12 months to apply across Great Britain until 31 December 2023, to ensure British people...
Europe – Regulatory information – adjusted fees for pharmacovigilance applications from 3 October 2022
Pharmacovigilance fees payable to the European Medicines Agency by applicants and marketing authorisation holders increase by 5.6% as of 3 October 2022, to reflect the inflation rate...
Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 26-29 September 2022
New measures for terlipressin-containing medicines in the treatment of hepatorenal syndrome
EMA’s safety committee (PRAC) recommended new measures to reduce the risk of respiratory failure...
Europe – EMA pilot offers enhanced support to academic and non-profit developers of advanced...
EMA is launching a pilot to support the translation of basic research developments into medicines that could make a difference in patients’ lives in...
UK – MSD’s pembrolizumab therapy gets NICE approval
An estimated 1,500 people aged 12 years and over with melanoma are set to benefit from MSD’s – known as Merck & Co in the...
Europe – CHMP recommends 12 new medicines, including first RSV treatment for infants
The European Medicine Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) last week endorsed 12 new medicines for authorization, including the first treatment to...
Europe – Biosimilar medicines can be interchanged
EMA and the Heads of Medicines Agencies (HMA) have issued a joint statement confirming that biosimilar medicines approved in the European Union (EU) are interchangeable with their reference...
