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 – Genetically altered vaccines developed to help eradicate polio
Polio is a highly infectious viral disease that largely affects children aged under five years. The virus is transmitted by person-to-person and multiplies in...
International – ICH details milestones reached on guidelines after Athens meeting
The International Council for Harmonisation (ICH) announced it has reached several milestones over the past year, including advancing guidelines on validating analytical procedures for...
International – WHO warns on contaminated cough syrups linked to child deaths
This WHO Medical Product Alert refers to two substandard (contaminated) products, identified in Uzbekistan and reported to WHO on 22 December 2022. Substandard medical...
International – The WHO anatomical therapeutic chemical/defined daily dose toolkit
This article provides a high-level overview of the anatomical therapeutic chemical/defined daily dose (ATC/DDD) toolkit developed by the World Health Organization (WHO) for drug...
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 – ICH Q14: Pharma groups want clarity on benefits of enhanced approach
Pharmaceutical industry groups questioned whether following the enhanced approach in International Council for Harmonization (ICH) Q14 guidance will confer regulatory relief for manufacturers that...
International – WHO seeks to align biowaiver policy with ICH guidelines
The World Health Organization (WHO) wants to align its bioequivalence classifications with other global guidelines by reducing the number of in vivo studies required to prove...
International – Generic industry group wants clarity on ICH bioequivalence guideline
The Association for Accessible Medicines (AAM) said the US Food and Drug Administration (FDA) should ensure alignment between the International Council on Harmonisation’s (ICH)...
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...
