Snapshot

The Temporary Use Authorization (ATU) pathway has been developed by the of Ivory Coast.

This pathway can be used where Unregistered pharmaceutical products or the unapproved use of registered pharmaceutical products in the context of a public health emergency, to diagnose, treat or prevent serious or life-threatening diseases or conditions, in the absence of adequate, approved and available alternatives. .

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Target time assessment is Two (2) exemption schemes to the marketing authorization procedure are possible in order to make pharmaceutical products that do not have a marketing authorization or certificate of compliance available as quickly as possible in an emergency and/or when there is a public health need. Temporary Use Authorization (ATU): The exceptional use of pharmaceutical products that do not have marketing authorization and are not subject to clinical trials in Côte d'Ivoire is subject to obtaining prior Temporary Use Authorization (ATU) issued by the Ivorian Pharmaceutical Regulatory Authority (AIRP). In practice, there are two types of temporary authorizations for use (ATU): 1) The so-called nominative ATU (ATUn) is issued for a single, named patient who is unable to participate in ongoing biomedical research in Côte d'Ivoire, at the request and under the responsibility of a registered prescribing physician, provided that the pharmaceutical product is likely to benefit that patient. These are pharmaceutical products whose efficacy/safety ratio is presumed to be favorable for these patients in view of the available data. 2) Cohort ATU (ATUc) concerns pharmaceutical products whose efficacy and safety of use are strongly presumed, and which are intended for a group or subgroup of patients treated and monitored according to criteria defined in a protocol for therapeutic use and information collection (PUT). A Protocol for Therapeutic Use and Information Collection (PUT), established between the AIRP and the holder/operator of the marketing authorization for the pharmaceutical product, must be put in place for all nominative ATUs and cohort ATUs. This PUT sets out, in particular, the procedures for monitoring patients receiving treatment and for collecting data on efficacy, adverse effects, actual conditions of use and the characteristics of the population benefiting from the authorized product. It also contains information specifically written for patients, which must be provided to them by prescribers. The following situations do not fall within the scope of ATUs: • continuation of treatment at the end of a clinical trial; • the use of a hospital or extemporaneous preparation made from a pharmaceutical product that does not have marketing authorisation in Côte d'Ivoire; • pharmaceutical products benefiting from an import authorisation issued by the AIRP in the context of their unavailability on the national territory (due to a stock shortage or a marketing discontinuation). The AIRP's response time to named ATU requests is 7 to 21 days on average..