Guidance on Complex Clinical Trials and Seasonal Vaccine Trials
Guidance issued on the conduct and authorisation of complex clinical trials and trials involving seasonal vaccines.
Danish Medicines Agency · DenmarkDenmark
Regulation
Category
Type
Date
Q&A update: Non-clinical package for clinical trial applications – GLP status for pivotal animal studies
Updated Q&A guidance clarifying GLP status requirements for pivotal animal studies in clinical trial applications across all drug development stages.
Danish Medicines Agency · DenmarkNew short guidance for psychiatrists and general practitioners on ADHD medication
Danish Medicines Council publishes new brief guidance for psychiatrists and GPs on ADHD medication prescribing.
Medicinrådet (Danish Medicines Council) · DenmarkCTIS safety module go-live postponed
The Clinical Trials Information System safety module go-live has been postponed; details available in the Clinical Trials Newsletter.
Danish Medicines Agency · DenmarkNew Safety Module in the Clinical Trials Information System (CTIS)
A new Safety Module in CTIS will launch on 28 September 2026, with a two-month transition period ending 30 November 2026.
Danish Medicines Agency · DenmarkAI chatbot provides quick answers about Medicinrådet
På medicinraadet.dk kan brugerne få hjælp af chatbotten MAIA til at finde svar på faktuelle spørgsmål om habilitet, Medicinrådets vurderinger af nye lægemidler, faglige begreber og meget mere. Chatbotten bruger kunsti...
Medicinrådet (Danish Medicines Council) · DenmarkMedicinrådet strengthens visibility of patient contributions in assessment of new medicines
Danish Medicines Council introduces dedicated section in assessment reports to highlight patient representative input and systematise patient perspective in committee work.
Medicinrådet (Danish Medicines Council) · DenmarkMedicinrådet collaborates with DARE on real-world data
Danish Medicines Council announces collaboration with DARE on real-world data initiatives.
Medicinrådet (Danish Medicines Council) · DenmarkDanish Medicines Agency ATMP Open House
Are you working with advanced therapies in Denmark? Join us on 23 October for an afternoon focused on the development and regulation of Advanced Therapy Medicinal Products (ATMPs).
Danish Medicines Agency · DenmarkNew overview of medicines for type 2 diabetes
01. september 2026
Medicinrådet (Danish Medicines Council) · DenmarkNew reading guide explains Medicinrådet's key technical terms and methods
Patientrepræsentanter deltager i næsten alle Medicinrådets fagudvalg, hvor de bidrager med viden om, hvordan sygdom og behandling påvirker patienters og pårørendes hverdag. Deres perspektiver er med til at kvalificere...
Medicinrådet (Danish Medicines Council) · DenmarkMedicinrådet and Amgros extend deadline for pharmaceutical companies to propose alternative pricing agreements
The Danish Medicines Council and Amgros have extended the deadline for pharmaceutical companies to propose alternative pricing agreements.
Medicinrådet (Danish Medicines Council) · DenmarkNew heart medicine recommended for patients without other treatment options
Medicinrådet recommends a new cardiac medicine for patients without alternative treatment options.
Medicinrådet (Danish Medicines Council) · DenmarkMedicines Council decisions: 2 September 2026 – vorasidenib and mavacamten recommendations
Medicinrådet recommended vorasidenib for rare inoperable brain cancer and mavacamten for obstructive hypertrophic cardiomyopathy when cardiac intervention is not an option.
Medicinrådet (Danish Medicines Council) · DenmarkMedicinrådet does not recommend givinostat for Duchenne muscular dystrophy due to uncertainty about effect size and duration
Danish Medicines Council recommends against reimbursement of givinostat for Duchenne muscular dystrophy citing insufficient evidence on effect magnitude and duration.
Medicinrådet (Danish Medicines Council) · DenmarkMavacamten: recommendation not yet entering into force due to pricing disagreement
Bristol Myers Squibb cannot maintain its price offer for mavacamten; the Danish Medicines Council recommendation does not enter into force.
Medicinrådet (Danish Medicines Council) · DenmarkMedicines Council meeting 30 September 2026: decisions overview
Medicinrådet recommends brexucabtagene autoleucel (Tecartus), an advanced therapy medicinal product, for blood and lymph cancer patients under a performance-based risk-sharing agreement.
Medicinrådet (Danish Medicines Council) · DenmarkReimbursement recommendation for brexucabtagene autoleucel (Tecartus) under outcome-based risk-sharing agreement
Danish Medicines Council recommends CAR-T cell therapy brexucabtagene autoleucel for acute lymphoblastic leukaemia and mantle cell lymphoma under an outcome-based risk-sharing agreement.
Medicinrådet (Danish Medicines Council) · DenmarkMedicinrådet recommends continued burosumab for children with rare bone disease XLH
Danish Medicines Council reaffirms recommendation for burosumab in children with X-linked hypophosphatemia following clinical experience review and price renegotiation.
Medicinrådet (Danish Medicines Council) · Denmark
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