Lead Story
DIN SPEC 91509: A milestone for structured, digital medical device documentation
This industry news update introduces a new model that will help with the digitalisation of documentation under EU law.
Industry news
MHRA points to clinical trial growth and faster assessment routes
This industry news update shares how clinical trials have grown over the past year and new regulations coming into effect.
MHRA invites Call for Evidence to assess AI regulation
This industry news update explains the reason for the MHRA’s Call for Evidence for AI regulation and provides guidance.
FDA and EMA publish guiding principles of good AI practice in drug development
This industry news updates shares the ten principles of best practice for AI.
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.
More news
DARWIN EU reaches more than 100 research studies
EMA launches #ItTakesATeam campaign to address medicine shortages
MHRA advances new reform for the treatment of rare diseases
EMA ETF offers scientific advice for antimicrobial resistance
EMA launches #HealthNotHype campaign
MHRA cuts approval times for UK clinical trials in half
NICE reviews health technology assessment to better support patients
