EDQM publishes New Chapter "Quality of Data" for Comments

The EU Pharmaceutical Legislation Reform: Impact on the API Industry

Recommendation

21 October 2025
Barcelona, Spain

The EU Pharmaceutical Legislation Reform: Impact on the API Industry
An ECA Course prior to the 28th APIC/CEFIC Global GMP & Regulatory API Conference

The draft of the new chapter "5.38. QUALITY OF DATA" has been published on the website of the EDQM (European Directorate for the Quality of Medicines & HealthCare) in the Pharmeuropa section and can be commented on until 31 December 2024, along with several other new drafts.

The draft of the new chapter refers to data that is generated, collected or used in the context of quality control and highlights its increasing importance in relation to the quality assessment of medicinal products. In particular, if this data is processed or read out using AI (artificial intelligence) and/or ML (machine learning), it is necessary to apply and guarantee a defined quality standard. To this end, the draft of the new chapter sets out specifications and definitions in six sections and several subsections.

You can view and comment on the draft of chapter "5.38. QUALITY OF DATA" on the Pharmeuropa website after registering once.