International – WHO charts path to convergence on cell and gene therapies

The World Health Organization (WHO) has issued a white paper for consultation that proposes a risk-based framework for regulating cell and gene therapy products (CGTPs) to...

International – ICH releases revised Q9 guideline to improve risk assessments

The International Council for Harmonization (ICH) issued a revision of the Q9 guideline that aims to address the shortcomings of the current guideline. The goal of...
ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials

International – Pharmaceutical groups want more clarity on continuous manufacturing guideline

Several industry trade associations are asking for more clarity on the International Council for Harmonisation’s (ICH) Q13 guideline on continuous manufacturing, including what constitutes...

International – ICH M7 Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals...

This guideline emphasizes considerations of both safety and quality risk management in establishing levels of mutagenic impurities that are expected to pose negligible carcinogenic risk....

International – ICMRA: Remote inspections can complement, but not replace, onsite inspections

While there are benefits to conducting remote good clinical practice (GCP) and good manufacturing practice (GMP) inspections and these assessments can continue being used...

International – Pfizer/BioNTech promote booster against Omicron

The studies, announced by Pfizer/BioNTech, indicate that a third dose of their vaccine increases neutralising antibody titres 25-fold compared to two doses against the...

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 – Booster plans expanded to combat Omicron

The UK will now offer all adults a booster jab by the end of January the government has announced. Previously, the scheme was restricted...

International – ICH recaps progress made over past year, charts new topics

The International Council for Harmonisation (ICH) announced that “significant milestones” were reached over the past year, including the adoption of the widely anticipated guideline...

Israel – Israel approves COVID-19 vaccines for children aged 5-11

 Israel said on Sunday that children aged five to 11 would be eligible for vaccination against COVID-19, and that a starting date for the...

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