Schema ATU RTU EN

A FULL-SERVICE MANAGEMENT of french specificities

There are in France two exceptional procedures which are designed to ensure equity of access and the greatest possible security for the use of medicines outside the existing regulatory fields.

  • The Temporary Authorisation for Use (ATU) which allows patients to benefit from pharmaceutical specialities whereas they do not have any marketing authorization, provided that they are intended for the treatment of serious or orphan diseases and in the absence of appropriate treatment.

  • The Recommendation for Temporary Use (RTU) which allows to monitor off-label prescribed medicines, provided that there is non covered therapeutic need, and that the benefit / risk ratio of the medicinal product is presumed favourable, in particular from published scientific data or effectiveness and safety.

ATU RTU AMM EN

When it comes to medicinal products which have not yet a Marketing Authorization, temporary authorizations for use (ATU) may be granted, thus ensuring an early access to these drugs.

Two types of ATUs are possible:

The so called "named patient ATU" concerns a single patient, designated by name and who cannot participate in a biomedical research. It is issued at the request and under the responsibility of the prescribing physician.

The so called "cohort ATU" affects a group or sub-group of patients. These are treated and monitored following the criteria perfectly defined in a protocol for therapeutic use (PTU) and a collection of information. 

The RTU may apply to all medicinal products with a marketing authorisation in France, on a temporary basis and not to exceed 3 years. Their development is solely the responsibility of the ANSM* when it identifies a non-compliance situation to the Marketing Authorisation. To this effect, it takes into account the quality of the scientific evidence, the innovative character and the safety profile of the drug, the prognosis and the frequency of the disease, as well as the existence of clinical trials in France in the indication.

The RTU is not intended to oppose the data of the SPC and cannot be in contradiction with the MA.


Well versed in the regulatory and logistical specificities of Temporary Authorizations for Use, ICTA’s ATU department has been offering since 2004 a proven expertise in the full-service management of named patient and cohort ATUs.
Since 2012, and in order to meet the requirements of the French ANSM*, regarding the monitoring of prescriptions outside the MA, this specialized department has extended its activities to the management of RTU by putting to use its 10 years’ experience in ATUs

FULL SERVICE MANAGEMENT OFFERED FOR YOUR ATU OR RTU:

COMMON SERVICES

  • Designing of documents
  • Setting up of a dedicated cell to provide interface between the sites and the sponsor
  • Organisation of logistical aspects
  • Management of the pharmacovigilance
  • Processing of data according to ICTA standard procedures
  • Data analysis
  • Drafting of reports 

  

ATU Specificites

RTU Specificites

  • Deployment of i-TMS (ICTA Trials Management System), IT tool for the management of ATUs, and in particular the management of the centers and different stakeholders.
  • Receipt of data collection forms, check on receipt for compliance upgrade with the sites in real time. 
  • Validation of inclusions and allocation of inclusion numbers for cohort ATU.
  • Management of products orders
  • Design of shareware tailored to the collection of data via I-SIS, our collaborative platform 
  • Development of automatisms for the organization of the data flow between the different stakeholders: workflows, e-mail alerts, reminders.
  • Provision of a hotline for health care professionals

*Agence Nationale de Sécurité du Médicament