Things are changing fast in Algeria: It has only been a few months since a Note was published to describe revised Safety Reporting requirements and the Algerian Authorities (1) have now published a full Pharmacovigilance Guide (2) with new changes to expedited reporting requirements.
The new Guide was produced by the “Centre National de Pharmacovigilance et de Materiovigilance” (CNPM) and includes a description of the local Pharmacovigilance System in Algeria. It covers the role of the stakeholders and includes a description of the obligations applicable to the Pharma Industry.
Among other topics, the Guide describes the expectations regarding the appointment of a Local Contact Person for Pharmacovigilance and for the maintenance and provision of the Pharmacovigilance System Master File (PSMF). The topics covered also include Procedures, Audits and Inspections, RMPs and PBRERs/PSURs, as well as Signal Management.
Regarding the Safety Reporting requirements, the Note published in June 2019 reduced drastically the number of ICSRs that required submission in Algeria by removing the obligation to include foreign ICSRs. The new Guide brings yet more changes when compared to the June 2019 Note and here is a summary of the resulting applicable ICSR reporting requirements:
Post-Marketing ICSRs, including cases originating from Non-Interventional Studies, must be submitted to the CNPM as follows:
- Domestic Serious ADRs: within 15 Calendar Days
- Domestic Non-Serious ADRs: within 90 Calendar Days
- All Foreign ADRs: through the PBRERs/PSURs
Clinical Trials ICSRs must be submitted to the CNPM and Ethics Committees as follows:
- Domestic Fatal/Life-Threatening SARs: initial report within 7 Calendar Days
- Other Domestic SARs: within 15 Calendar Days
- All Foreign ICSRs: through Annual DSURs
In other words, compared to the Note published in June 2019, there is no longer a requirement to submit Domestic Fatal/Life-Threatening Post-Marketing ADRs in 7 Days.
On the other hand, the requirements for Clinical Trials ICSRs now includes all SARs, whether they are unexpected (i.e. SUSARs) or not.
The Guide produced by the CNPM is only available in French and has been published on the website of the Agency. A copy was initially shared by a contact in Algeria and user of this blog, whom I would like to thank for notifying me of this new and important guidance.