International – ICMRA and WHO map out flexibilities used by regulators to respond to...
The International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO) have reviewed some of the practices applied by regulatory authorities worldwide to respond to...
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 – Mechanical, material stresses affect drug quality
Making medicines is a stressful business, literally. Bioprocessing technologies, cleaning agents, and even packaging can create stresses that impact drug quality. Understanding these stresses...
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 – 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 – 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 – 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 – 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 guideline M13A on bioequivalence for immediate-release solid oral dosage forms ICH...
ICH M13A Guideline is intended to provide recommendations on conducting bioequivalence (BE) studies during both development and post approval phases for orally administered immediate-release (IR) solid oral...
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...
