European Union clinical trials procedure

Hence, the standards for conducting clinical trials must be known before they can be applied. Standards are either international (e.g. ICH GCP), European (e.g. European Union Clinical Trials Directive (2001) and GCP Directive (2005)), national (i.e. national drug laws and GCP regulations) or even more local, such as State laws in the United States (Isidor and Kaltmann, 1999). Apart from the regulations, the clinical trial protocol, SOPs and other internal or external instructions document procedures how the trial should be carried out from start to finish. Compliance with these standards is expected. 

Compassionate use is a treatment option that allows the use of an unlicensed medicine. Compassionate use programmes are for patients in the European Union (EU) who have a disease with no satisfactory authorised therapies or cannot enter a clinical trial. They are intended to facilitate the availability to patients of new treatment options under development. To qualify for a compassionate use programme, the manufacturer calls on the national authorities for permission. The manufacturer must submit a request for the granting of a marketing authorisation or he must perform research in the context of a research programme with a cohort. Compassionate use procedures are also applicable for unlicensed medicines withdrawn from the market or for off-label use of licensed medicines. 

---