France – Avis relatif à la couverture des besoins de la population générale en...
Le HCSP évalue la couverture des besoins nutritionnels de la population pour le fer et la vitamine D dans le cadre de la mise...
France – L’ANSM publie les nouvelles règles des bonnes pratiques de préparation
Les nouvelles règles ont été élaborées grâce à un Comité scientifique regroupant pharmaciens hospitaliers, officinaux, inspecteurs et universitaires, ainsi qu’à partir des propositions formulées...
France – Virus de la variole du singe : recommandations pour sécuriser les dons...
Ces recommandations sont détaillées dans une note publiée sur notre site internet, mise à jour en novembre 2016. Elles concernent la collecte de selles pour la...
USA – OIG raises concerns about accelerated approval pathway
More than one-third of accelerated approval applications do not meet their original confirmatory trial dates, and four drug applications were more than 5 years...
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...
USA – Remote regulatory assessments: Pharma, device groups want more details on FDA guidance
Trade groups representing the pharmaceutical and medical device industries, while largely supporting the use of remote regulatory assessments (RRAs) as outlined in the US...
International – WHO reports warnings of ‘COVID-19 complacency’ from countries tracking global vaccine roll-out
Emphasising that the global pandemic is ‘not over’, the ACT-Accelerator’s Council Tracking and Accelerating Progress Working Group – co-chaired by Indonesia and the US...
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...
