Global Pharma Guidance Tracker – May 2022
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
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The European Medicines Agency has been on a steep learning curve with its qualification of a digitally-measured outcome for use in Duchenne muscular dystrophy trials, smoothing the way for other developers entering the digital biomarker space.
Regulators in the EU are to publish a roadmap next year on existing, ongoing and planned guidance activities on novel clinical trial methodologies.
EMA Considers Product Development Stage For Complying With ICH Guide On Bioanalytical Method Validation
The European Medicines Agency has drafted a plan to address specific issues that drug companies may face when it comes to complying with the International Council for Harmonisation’s M10 guideline.