Management of clinical trials in light of the current situation in Ukraine
The current situation in Ukraine can have an impact on the conduct of clinical trials. It can affect both the supply of trial-related drug products and the collection of critical data.
Therefore, an initial guidance on the management of clinical trials in light of the situation have been issued by the European Commission (EC), the European Medicines Agency (EMA) and the Clinical Trials Facilitation and Coordination Group (CTCG) – a working group under the European Heads of Medicines Agencies (HMA).
You can read more information in the EMA news on the impact of the war in Ukraine on clinical trials, and you can find the guidance from the CTCG here.
If Ukrainian trial participants arriving in Denmark have a medical need for trial-related drug products that are not available on the Danish market, a compassionate use permit is necessary. The compassionate use permit has to be applied for by a Danish physician and is only valid for the individual patient. If there is an urgent need for the compassionate use permit, please mark the application with “HASTER” (urgent) after the applicant’s name. The Danish Medicines Agency will try to process these applications within 24 hours.
You can find more information on our webpage for compassionate use permits.
If you have any questions about the impact of the war in Ukraine on the conduct and management of clinical trials, please feel free to contact us at + 45 44 88 91 23 or Send an email.