International – ICH advances guidelines on selective reporting of safety data, viral safety

The International Council for Harmonisation (ICH) recently announced the adoption of its E19 guideline, which outlines a risk-based approach for collecting safety data for...

International – ICH releases Q9 training materials on quality risk management

The International Council on Harmonization (ICH) has issued training materials to complement its revised Q9(R1) guideline on quality risk management aimed at assisting the...

International – Covid-19 nasal vaccine is here: Price, benefits, all you need to know

Vaccine maker Bharat Biotech's intranasal vaccine for Covid-19, the first in the world, is set to be launched soon and is already available on...

International – ICH M10 on bioanalytical method validation

This guideline is intended to provide recommendations for the validation of bioanalytical methods for chemical and biological drug quantification and their application in the...

International – ICH adopts S12 guideline for gene therapies

The International Council for Harmonisation (ICH) last week announced that its S12 guideline on nonclinical biodistribution (BD) considerations for gene therapy products has reached...

International – ICH releases M11 guideline proposing harmonized template for trial protocols

The International Council for Harmonisation (ICH) has released a draft guideline which outlines a harmonized template for clinical trial protocols to support consistent reporting...

International – ICH releases draft guidelines on analytical method development

The International Council for Harmonization (ICH) on Thursday issued two draft guidelines that should make it easier for manufacturers to switch analytical methods for...

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 – Novartis confirms death of 2 children after gene therapy

Novartis has recorded two deaths after treatment with its spinal muscular atrophy gene therapy Zolgensma, once again bringing gene therapy’s safety into attention. Two children...

Europe – ICH Guideline Q5A(R2) on viral safety evaluation of biotechnology products derived from...

This document considers testing and evaluation of the viral safety of biotechnology products derived from characterised cell lines of human or animal origin. It outlines...

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