EMA’s safety committee (PRAC) has started a review of a safety signal to assess reports of acute kidney injury in some patients with COVID-19 taking Veklury (remdesivir). Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 September – 1 October 2020
Volume II. Vigilance of clinical trials Conduct of research involving the human person mentioned in 1 ° of Article L. 1121-1 of the public health code relating to the drug: Adverse reaction reporting, developments and reports annual security JANUARY 2020
The United Kingdom (UK) formally leaves the European Union (EU) on 31 January 2020 and becomes a third country
New and innovative technologies have led to an explosion in data coming from novel data sources that have not been widely utilized within medicines regulation
Faster patient access to highly innovative therapies
ANSM wants to strengthen the pharmacist’s advisory role for the use of Paracetamol and nonsteroidal anti-inflammatory drugs
First vaccine for active immunisation of individuals aged 18 years and older at risk of infection with the Ebola virus.
ANSM has decided to perpetuate the two accelerated clinical trial authorization devices (Fast Track)
