FDA
FDA issues final rule updating nonclinical testing terminology
FDA substituted certain references to animal, preclinical, and in vitro tests or studies with consistent nonclinical terminology. The rule adds definitions and conforming amendments, aligns regulations with statutory changes, and adds no new requirements.
Read the official sourceFDA
FDA proposes corresponding nonclinical terminology amendments
FDA proposed terminology and definitional changes intended to remove emphasis on animal testing as the only scientific methodology for nonclinical safety assessment. The proposal would add no new requirements.
Read the official sourceEMA
EMA adopts ICH M13B at Step 5
EMA lists the ICH M13B guideline on additional strengths biowaivers for immediate-release solid oral dosage forms as adopted.
Read the official sourceMHRA
MHRA seeks views on AI in medicines development
MHRA and the Regulatory Innovation Office opened a survey inviting organisations to share views on using artificial intelligence in medicines development.
Read the official sourceMHRA
UK launches regulatory science funding opportunity
Four planned centres of excellence will bring together academia, industry, healthcare, and regulatory expertise to support regulatory science and healthcare innovation.
Read the official sourceWhy this matters
Regulatory teams should note the shift toward broader nonclinical terminology in FDA regulations and EMA’s adoption of a harmonised biowaiver guideline. The MHRA survey also provides a direct opportunity for organisations to inform discussion about AI in medicines development.
Scott Morvay
Founder, Gulfstream Intelligence
This brief provides general regulatory news and educational information. It is not legal or regulatory advice.