International – ICH adopts Q9 guidelines on quality risk management
The International Council for Harmonisation (ICH) has adopted a revised version of its Q9 guideline that aims to improve current quality risk management (QRM)...
International – Pfizer and BioNTech share positive results for Omicron-adapted COVID-19 vaccine
The data shows that a booster dose of both Omicron-adapted vaccines gave a considerably higher immune response against Omicron BA.1, compared to Pfizer/BioNTech’s current...
International – ICH releases draft guideline proposing harmonized bioequivalence testing
The International Council for Harmonisation (ICH) last month released a draft M13A guideline which proposes harmonized bioequivalence (BE) testing of new orally administered immediate-release...
International – ICH guideline Q3C (R8) on impurities: guideline for residual solvents Step 5
The objective of this guideline is to recommend acceptable amounts for residual solvents in
pharmaceuticals for the safety of the patient. The guideline recommends use...
International – ICH paper calls for ‘stepwise’ harmonization of RWE
The International Council for Harmonisation (ICH) issued a Reflection Paper outlining a “stepwise” approach to harmonization of real-world data and evidence (RWD/RWE) that includes...
International – Efficacité et tolérance des vaccins contre la COVID‐19
Nous avons inclus et analysé 41 ECR évaluant 12 vaccins différents, y compris les schémas vaccinaux homologues et hétérologues et l'effet des doses de...
International – ICH charts new topics, touts progress in updating existing guidelines
The International Council for Harmonisation (ICH) announced plans to work on three new topics this year covering patient preference studies, non-clinical safety studies for...
International – Convergence: Confusion lingers over interchangeability and switching of biosimilars
While there are some areas of general alignment on standards for accepting biosimilar applications in the US, EU and Canada, some differences are impeding...
International – ICH to adopt final guideline on drug interaction studies early next year
The pharmaceutical industry would like to get more clarity on the timing of drug-drug interaction (DDI) studies and the scope of these DDI studies...
International – ICH M13A BE testing guideline expected to be adopted this summer
The International Council for Harmonisation (ICH) is expected to adopt its M13A guideline on bioequivalence (BE) testing of immediate-release (IR) solid oral dosage form...
