www.ema.europa.eu The European Medicines Agency (EMA) reminds applicants and marketing authorisation holders that adjusted fees for all applications, except for pharmacovigilance procedures, will be coming into effect on 1 April 2023.Every year, the European Commission adopts a regulation...

www.ema.europa.eu Nine new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended nine medicines for approval at its March 2023 meeting.The CHMP recommended authorising the COVID-19 vaccine Bimervax (previously COVID-19 Vaccine HIPRA) as a booster in people...

www.ema.europa.eu EMA’s human medicines committee (CHMP) has recommended authorising the COVID-19 vaccine Bimervax (previously COVID-19 Vaccine HIPRA) as a booster in people aged 16 years and above who have been vaccinated with an mRNA COVID-19 vaccine.Bimervax, developed by HIPRA Human...

www.ema.europa.eu DARWIN EU®, the Data Analysis and Real-World Interrogation Network, has accomplished its first year of establishment. Following the set-up of the DARWIN EU® Coordination Centre in February 2022, the first ten data partners were onboarded. The network also initiated its...

www.ema.europa.eu CVMP opinions on veterinary medicinal productsUnder Regulation (EC) No 726/2004The Committee adopted by consensus a positive opinion for a marketing authorisation of Newflend ND H9, from Ceva-Phylaxia Co. Ltd., a new vaccine for the active immunisation of one-day-old...

www.ema.europa.eu EMA has published a report summarising the mid-term achievements of its Regulatory Science Strategy (RSS) to 2025. The report provides an overview of the main deliverables achieved between March 2020 and December 2022 across the human and veterinary areas.“The achievements...