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Figure 1
The Basic Regulatory Expectations (Requirements) of Using Digital Health Technology for Clinical Studies
GMP / GLP / GCP
BackgroundDefinitions and MeaningBenefits and ChallengesRecommendations of FDA DHT Draft GuidanceOther Aspects and Contents of the FDA DHT Draft GuidanceDraft Guideline on Computerised Systems and Electronic Data in Clinical Trials of EMASummary
Zusammenfassung
Im Jahr 2021 haben die European Medicines Agency (EMA) und die U.S. Food and Drug Administration (FDA) jeweils einen Entwurf eines Leitfadens bzgl. computergestützter Systeme bzw. Digital Health Technology (DHT) in klinischen Prüfungen veröffentlicht. Der folgende Beitrag enthält eine kurze Zusammenfassung der FDA-DHT-Guidance unter Berücksichtigung des EMA-Leitfadens.
Bohong Meng
 | Bohong Meng is a pharmacist. She studied public finances and law at the Dalian Maritime University in China and pharmacy at the University of Erlangen- Nuremberg. After finishing her studies, she worked in QA, QC and Regulatory Affairs for various companies such as ratiopharm, TEVA Ulm, and Boehringer-Ingelheim Biberach. |
Abstract
In 2021, 2 draft guidelines about computerized systems and Digital Health Technology (DHT) in clinical investigation were published by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). The following article is a brief summary about the FDA DHT draft guidance with consideration of the EMA draft guideline.
