France – Forfait innovation : une 1ère technologie de santé inscrite au remboursement par...
Mis en place en 2009 et piloté par le ministère chargé de la santé, le forfait innovation est un dispositif dérogatoire et temporaire de...
Europe – European Commission proposes framework for joint clinical assessments
The European Commission has proposed a framework for joint clinical assessments (JCA) as part of its effort to implement the EU health technology assessment...
UK – UK’s MHRA approves first drug under international recognition procedure
The UK Medicines and Healthcare products Regulatory Agency (MHRA) recently approved Amgen’s bone cancer drug Xgeva (denosumab), the first drug submitted through the international...
International – ICH E2D(R1) Guideline on post-approval safety data: definitions and standards for management...
It is important to establish an internationally standardised procedure to ensure the quality of post approval safety information and to harmonise, where feasible, the...
USA – Cell therapy equipment: regulatory guidelines and feedback opportunities
Cell therapy manufacturing requires specialized equipment to prioritize cell health, yield, and performance. A range of suppliers offer tailored equipment, but evolving regulatory guidance...
USA – FDA updates early Alzheimer’s drug development guidance to add support for biomarkers,...
The US Food and Drug Administration (FDA) has released a second revision of its draft guidance for developing drugs intended to treat early Alzheimer’s...
Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 March 2024
EMA’s safety committee (PRAC) concluded that there was insufficient evidence to establish a causal association between the COVID-19 vaccines Comirnaty and Spikevax and cases of...
France – La HAS actualise la stratégie de vaccination contre le zona
Causé par la réactivation du virus varicelle-zona, le zona est une affection virale de la peau et des muqueuses qui touche particulièrement les personnes...
Europe – DARWIN EU® continues expanding its capacity to deliver real-world data studies
The Data Analysis and Real World Interrogation Network DARWIN EU will continue working towards higher capacity for real-world data (RWD) studies and seeks to...
Switzerland – Nouvelles autorisations de médicaments complémentaires et de phytomédicaments
Chaque année, un grand nombre de médicaments complémentaires et de phytomédicaments ainsi que de bonbons et pastilles pour la gorge et contre la toux...
