International – ICH signs off on carcinogenicity testing addendum
The International Council for Harmonisation (ICH) recently announced that its S1B(R1) addendum outlining a “weight of evidence” (WoE) approach to assess the human carcinogenic...
International – ICH adopts M7(R2) guideline on mutagenic impurities to limit carcinogenic risk
The International Council for Harmonisation (ICH) earlier this week announced the adoption of its M7(R2) guideline that aims to harmonize the framework for assessing...
International – ICH M11 guideline, clinical study protocol template and technical specifications
The purpose of this new harmonised guideline is to introduce the clinical protocol template and the technical specification to ensure that protocols are prepared in a...
International – ICH plans model-informed drug development guideline in 3-4 years
The International Council for Harmonisation (ICH) released a widely anticipated timetable detailing its plans to issue general guidance on model-informed drug development (MIDD) approaches...
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 – Pharma groups question enhanced approach in Q14, call for more alignment between...
Pharmaceutical industry groups praised certain aspects of the International Council for Harmonisation (ICH) draft Q14 and Q2(R2) guidelines yet had questions on how enhanced...
International – WHO proposes updated excipient GMPs in wake of contaminated cough syrup
The World Health Organization (WHO) recently proposed updated guidance to assist pharmaceutical manufacturers in assessing the quality of excipients after child deaths were reported...
International – Modular plug-and-produce facilities for cell therapies
At the start of 2021, a crane lifted a shrink-wrapped, elongated structure off a truck flatbed and through a window into an upper floor...
International – WHO recommends Veklury for high-risk patients
The World Health Organisation (WHO) has recommended Veklury (remdesivir) for the treatment of patients with non-severe COVID-19 who are at the highest risk of...
USA – Pharma groups say ICH guideline on viral safety evaluation needs to incorporate...
US pharmaceutical industry groups endorsed the major principles of the International Council for Harmonization’s (ICH) Q5A(R2) guideline on viral safety of biotechnology products but...
