ATU & RTU - Euraxipharma

An ATU (temporary authorisation for use) is the French version of compassionate use and is granted by the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) in France subject to the following conditions:
– Specials are to be used for treating, preventing or diagnosing serious or rare diseases
– No other appropriate treatment is available
– There is sufficient scientific evidence to show their efficacy and safety
In practice, there are two kinds of ATU: cohort ATUs and named patient ATUs.

In France, the ANSM grants an RTU (temporary recommendation for use) to cover off-label prescriptions that do not comply with the marketing approval obtained, as long as:
– There is a therapeutic need
– The risk/benefit ratio is considered as favourable, in particlular in reference to published scientific data concerning efficacy and tolerance
The aim is to ensure that medicinal products are used safely through patient follow-up organised by the laboratories concerned.

We have created a team specialised in handling and following up ATUs and RTUs and ready to share its experience with you and provide advice on your projects.

Protocol for Therapeutic Use (PTU)

– Assistance with writing the protocol whether for a named-patient or cohort ATU or an RTU
– Critical revision, especially for appendices covering data collection
– Finalising of layout and distribution to physicians, pharmacists, French Regional Pharmacovigilance Centres (CRPV) and French Poison Centres (CAP)

ATU/RTU unit

– Creation of a dedicated team with back-ups
– Assigning a dedicated freephone no./fax no./e-mail account
– Management, revision, compliance-checking and validation of data

Web portal/Data collection

Web portal/data collection

Installing of a modular application dedicated to collecting data:

– Account creation module

– Data collection module

– Documentation module

– Reporting module

For ATUs, data can be collected via a paper or electronic CRF or a combination of both.

ATU and RTU specifics

ATU specifics:
– Medical validation of access to treatment requests
– Management of treatment ordering logistics

RTU specifics:
– Management of data flows
– Creation of automatic alerts

Pharmacovigilance and periodic report

– Management of pharmacovigilance cases together with the sponsor
– Write-up of oral statements
– Management of queries together with the sponsor’s pharmacovigilance unit
– Creation of e-mail alerts
– Quality control
– Production of French and English versions of summary reports and synopses