International – The subjectivity of starting materials in the era of harmonization
Regulatory starting materials (RSMs) represent the starting point of drug substance synthesis from which subsequent steps are carried out under good manufacturing practice (GMP)...
International – ICH adopts guidelines on viral safety evaluation and analytical method development
The International Council for Harmonisation (ICH) announced on 8 November the adoption of its Q5A(R2) guideline on viral safety evaluation of biotechnology products as...
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 – The WHO anatomical therapeutic chemical/defined daily dose toolkit
This article provides a high-level overview of the anatomical therapeutic chemical/defined daily dose (ATC/DDD) toolkit developed by the World Health Organization (WHO) for drug...
International – E-labeling and digital transformation in healthcare
This article examines the regulations for electronic labeling (e-labeling) for prescription drugs and medical devices in Japan, Brazil, Singapore, the EU and US, Canada,...
International – FDA announces completion of first joint assessment with EMA in ICMRA pilot
The US Food and Drug Administration (FDA) on Friday announced the completion of its first collaborative assessment of a post-approval change for an oncology...
International – WHO proposes best practices for clinical trials
The World Health Organization (WHO) has issued a draft guidance spelling out some of the important scientific and ethical considerations for well-designed clinical trials....
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...
