A new IT project called the Digital Application Dataset Integration (DADI) has been launched in the EU. The DADI project will replace the current PDF-file based electronic application forms (eAFs) with the web-based system. The new system will use the Fast Healthcare Interoperability Resources (FHIR) data standard which is the same one which is in use within the EU ISO IDMP (Identification of Medicinal Products) standards. The project will incorporate the learnings and developments of the CESSP phase 1 project. The project plan is under elaboration and further information (eg. timelines) will be shared in May. The variations application form (Human and Veterinary) will be the first area of focus.
Biological medicines: how does their manufacturing process differ from traditional medicines?
The differences in the manufacturing process and the nature of the active substance itself mean that biologicals differ from traditional medicines in many ways.
EU Council to postpone the MDR deadlines
The commission’s plan would not automatically apply an extended transitional period for all the medical devices, but the extension would be allowed on the condition that it is critical for the safety of the patients.