On November 27, 2025, European regulators and ethics committees agreed to pilot FAST‑EU, a new fast‑track approach for authorizing multinational clinical trials. Launching in January 2026, this initiative aims to deliver quicker, more predictable approvals while upholding Europe’s high scientific, ethical, and safety standards.

Analyse/Research

Active substance: misoprostol Reminder of the authorisation-compliant application.

The article provides information on the correct procedure for approval procedures in accordance with Section 31 StrlSchG (Strahlenschutzgesetz (German Radiation Protection Act)) in the context of CTR applications and Substantial Modification in CTIS.

Active substance: azithromycin The European Commission's final decision on the risk assessment procedure for azithromycin has been published.

This report highlights two key milestones: the recent manual workshop in Tanzania and the first continental clinical assessment training – both of which underscore the fellowship's commitment to capacity-building and harmonization across the African continent.

Causes of death coding in Iris with ICD-11 testing results

CHMP Meeting Highlights July 2025

CHMP Meeting Highlights June 2025

CHMP Meeting Highlights May 2025

Pursuant to the Regulations (EU) 2017/745 and (EU) 2017/746 (MDR and IVDR) as well as German national regulations a favourable opinion of the competent ethics committee and an approval of or notification to the competent authority is required in order to perform a clinical investigation / performance study for medical devices.

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Comments concerning texts published in Issue 12.2

State: October 2025

Active substance: betaine SERB Pharmaceuticals has reported that three batches were packaged for the German market with a faulty PZN number in the NTIN-DE and in the 2D barcode.

Active substance: caspofungin The marketing authorisation holders of caspofungin containing medicines would like to inform that during treatment with caspofungin the use of polyacrylonitrile membranes during continuous renal replacement therapy should be avoided.

Active substance: clozapine The marketing authorisation holders of clozapine-containing medicinal products provide information on the revised recommendations for routine blood count monitoring.

Active substance: risdiplam The marketing authorization holder Roche Registration GmbH informs about the omission of a mandatory labelling statement on the bottle labels, product carton, summary of product characteristics and Instruction for
Constitution.

Active substance: finasteride, dutasteride The marketing authorisation holders of finasteride- and dutasteride-containing medicinal products provide information on suicidal thoughts as an adverse drug reaction of orally administered finasteride-containing products.