France – La campagne de vaccination contre le Covid-19 avancée au 2 octobre alors...
Face à une augmentation de la circulation du virus responsable du Covid-19, le ministre de la santé, Aurélien Rousseau, a décidé d’avancer la campagne...
Europe – European Commission proposes updates to medical device phthalates guidelines
The European Commission has launched a public consultation on an update to its guidelines on benefit-risk assessments for medical devices containing phthalates. This is...
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...
Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 November –...
EMA recommends withdrawal of pholcodine medicines from EU market
EMA’s safety committee, PRAC, has concluded its review of medicines containing pholcodine, which are used in adults...
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...
Europe – New agreement places Northern Ireland regulation back in the UK
Regulation of human medicines in Northern Ireland now are the responsibility of the UK Medicines and Healthcare products Regulatory Agency (MRHA) under an changes...
USA – FDA issues guidance on developing long-acting local anesthetics
The US Food and Drug Administration (FDA) has issued draft guidance on the development of local anesthetic products with a prolonged duration of effect...
UK – Nitrosamines impurities in medicines
The Medicines and Healthcare products Regulatory Agency (MHRA) has assessed the risk of nitrosamine formation or presence during the manufacture of human medicines and...
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...
USA – FDA to require new safety warnings for opioids
The US Food and Drug Administration (FDA) last week announced new labeling updates and safety warnings for immediate-release (IR) and extended-released/long acting (ER/LA) opioids...
