EMA
EMA opens predictive biomarker assay guideline consultation
EMA published a draft guideline on predictive biomarker assays across the medicinal product lifecycle, with consultation open.
Read the official sourceEMA
EMA consults on reproductive and breastfeeding risk assessment
EMA opened consultation on Revision 1 of its draft guideline covering risk assessment in human reproduction and breastfeeding, from data through product information.
Read the official sourceMHRA
MHRA updates ILAP guidance
MHRA updated guidance on the Innovative Licensing and Access Pathway, which focuses on bringing transformative new medicines to patients in the UK health system more quickly.
Read the official sourceMHRA
MHRA updates 2026 marketing authorisations record
MHRA published its record of marketing authorisations granted in 2026.
Read the official sourceMHRA
MHRA updates 2026 parallel import licence record
MHRA published its record of parallel import licences granted in 2026.
Read the official sourceWhy this matters
The EMA consultations give regulatory teams an opportunity to review evolving expectations for biomarker assays and reproductive risk communication. The MHRA updates provide current reference points for UK access pathways, marketing authorisations and parallel imports.
Scott Morvay
Founder, Gulfstream Intelligence
This brief provides general regulatory news and educational information. It is not legal or regulatory advice.