Regulatory Rapporteur December 2025 – Contents
North America: Transparency, transformation and innovation pathways
From laboratory to patient: The role of New Substance Notifications in delivering innovative therapies in Canada
Cross-functional strategies in clinical data disclosure for EMA Policy 0070 and Health Canada PRCI
A year of change for the US FDA: An update on notable pilots and programmes
Bringing innovation to market: Regulatory strategy for MedTech companies
Bridging the digital divide: A toolkit for equity-centred regulation of digital mental health
Medical device standards update: December 2025
2025 Regulatory Intelligence Conference Europe: Meeting report
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Saudi FDA vision to be a leading regulator includes updating guidance on combination products
This industry news updates shares Saudi FDA’s updated guidance for combination products.
EC proposes regulation to simplify rules on medical and in vitro diagnostic devices
This industry news update shares the EC’saim to simplify medical and IVD device rules through a new proposal.
The VMD changes how it calculates adverse events incidents for animals
This industry news update shares the VMD’s changes to how it calculates adverse events, which has now taken full effect.
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DARWIN EU reaches more than 100 research studies
This industry news update shares a major milestone for DARWIN EU that has reached more than 100 research studies.
EMA launches #ItTakesATeam campaign to address medicine shortages
This industry news update explains the #ItTakesATeam campaign which aims to raise awareness of medicine shortages.
MHRA advances new reform for the treatment of rare diseases
This industry news update explores the MHRA’s upcoming framework that addresses treatments related to rare diseases.
EMA ETF offers scientific advice for antimicrobial resistance
This is an industry news update about the EMA’s ETF that offers scientific advice for antimicrobial resistance.
RegRapPod − InConversation with Zohra Nasir and Aksa Rahman
InConversation talks careers withZohra Nasir and Aksa Rahman
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