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 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 – 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 – Convergence: Confusion lingers over interchangeability and switching of biosimilars
While there are some areas of general alignment on standards for accepting biosimilar applications in the US, EU and Canada, some differences are impeding...
International – E6(R3): ICH releases draft of overhauled GCP guideline for consultation
The International Council for Harmonisation (ICH) on Tuesday published the long-awaited draft version of its ICH E6(R3) guideline on good clinical practice (GCP) for...
International – ICH S5 (R3) Guideline on detection of reproductive and developmental toxicity for...
The purpose of this document is to recommend international standards for, and promote harmonization of, the assessment of nonclinical developmental and reproductive toxicity (DART)...
International – ICH guideline S12 on nonclinical biodistribution considerations for gene therapy products –...
The objective of this guideline is to provide harmonised recommendations for the conduct of nonclinical biodistribution (BD) studies in the development of gene therapy (GT) products....
International – Generic industry group wants clarity on ICH bioequivalence guideline
The Association for Accessible Medicines (AAM) said the US Food and Drug Administration (FDA) should ensure alignment between the International Council on Harmonisation’s (ICH)...
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 – 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...
