Pharmacovigilance requirements in Algeria – Interesting Facts!
Pharmacovigilance requirements in Algeria – Interesting Facts!
Algeria is a North African country located somewhat close to the European Union.
The Centre National de Pharmacovigilance et de Materiovigilance (CNPM) updated the Pharmacovigilance guideline in 2019, and it is more or less on the lines of GVP, with some minor alterations.
Some examples include:
1. ICSRs
· Domestic Serious – 15 Calendar Days
· Domestic Non-Serious – 90 Calendar Days
· Foreign reports only need to be included in PSURs
2. PSURs
· New Products – Six Monthly for the initial two years and then every three years.
· As per EURD
3. Local Qualified Person for Pharmacovigilance is the RPV. Suppose the RPV does not reside in Algeria. In that case, the company needs to nominate a local person who can liaise between the CNPM and the Pharmacovigilance head located internationally.
4. Besides, PSMF is required. Also, RMP is necessary for some products. Signal management is also needed to be performed for the company products.
Apart from these, the CNPM facilitates online reporting of Adverse Events, and there is something called the yellow form that is meant for reporting by HCPs. Besides, there is a separate online form in French/ Arabic that can be used by patients/ consumers for reporting adverse events.
Besides, what was notable is that the CNPM organises Pharmacovigilance seminars. Besides, there are other options for Pharmacovigilance training.
The CNPM Pharmacovigilance guideline is available only in French. Besides, there are specific requirements for adverse events from clinical studies, including annual DSURs.
When it comes to patient safety, we need to consider the aspects beyond Pharmacovigilance. In Algeria, we have the following forms for online reporting adverse events associated with medical devices, vaccines, reactants, plant-based medicines, cosmetics and food supplements:
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