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...
International – ICH Q12 IWG “Regulatory and Technical Considerations for Pharmaceutical Product Lifecycle Management »
L'ICH Q12 (IWG) "Regulatory and Technical Considerations for Pharmaceutical Product Lifecycle Management" Module 8 Training Material est désormais accessible sur le site web de...
France – Cannabis médical : point d’étape sur la dernière année de l’expérimentation et...
La fin de l'expérimentation et la mise à disposition pour 2025 des médicaments à base de cannabis se préparent. Ces médicaments devront avoir obtenu...
USA – Clinical Pharmacology Considerations for Antibody-Drug Conjugates Guidance for Industry
This guidance provides recommendations to assist industry and other parties involved in the development of antibody-drug conjugates (ADCs) with a cytotoxic small-molecule drug or...
USA – How to learn about biologics CMC: advice on technical issues, regulatory strategy,...
Chemistry, manufacturing and controls (CMC) are an integral step in creating an effective biological product — and a crucial element of an effective biologics...
International – ICH targets cell and gene therapies, real-world data as topics ripe for...
Officials from Health Canada and the pharmaceutical industry addressed plans to develop harmonized guidelines on cell and gene therapies and on the design of...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
10 new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended 10 medicines for approval at its February 2024 meeting.
The committee adopted positive opinions...
USA – Industry urges FDA to do more to help companies prepare for DSCSA
The pharmaceutical industry urged the US Food and Drug Administration (FDA) to take a more “assertive and forward-leaning” approach in assisting pharmaceutical manufacturers prepare...
