International – ICH guideline S1B(R1) on testing for carcinogenicity of pharmaceuticals Step5
Historically, the regulatory requirements for the assessment of the carcinogenic potential of
pharmaceuticals in the three regions (E.U., Japan, U.S.) provided for the conduct of...
International – WHO releases key regulatory considerations on AI for health
The World Health Organization (WHO) has published new key regulatory considerations on artificial intelligence (AI) for health to emphasise the importance of establishing the...
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 – Expert review shows AstraZeneca’s COVID-19 vaccine is ‘equally effective’ as mRNA vaccines
Infectious disease experts from Asia reviewed data from the VIEW-hub database on vaccine use and impact, developed by John Hopkins Bloomberg School of Public...
International – EMA-FDA parallel scientific advice program has ‘limited’ uptake
A review of the last five years of the Parallel Scientific Advice (PSA) program between the US Food and Drug Administration (FDA) and the...
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...
