Quote from VigiServe Admin on November 28, 2020, 9:06 AM

In Algeria, the pharmacovigilance system is strictly regulated and mature, governed jointly by the Ministry of Health and the Ministry of Pharmaceutical Industry. The operational bodies are the National Center for Pharmacovigilance and Materiovigilance (CNPM) for technical monitoring and the National Agency for Pharmaceutical Products (ANPP) for regulatory oversight.

1. Clinical Safety (Clinical Trials)

• Expedited Reporting: While the provided text focuses on post-marketing, standard practice for clinical trials in Algeria aligns with international norms (ICH), requiring SUSAR reporting.

  • Fatal or Life-Threatening: Within 7 calendar days.

  • Other Serious Unexpected: Within 15 calendar days.

• Emergency Use: For products under emergency use listing, serious adverse events must be notified within 24 hours.

2. Post-Marketing Pharmacovigilance

Post-approval obligations are rigorous and require significant local presence.

• Personnel: A Local Qualified Person for Pharmacovigilance (QPPV) is mandatory. This person must be a Pharmacist (Doctor of Pharmacy) residing in Algeria and available 24/7.

• Documentation: A Pharmacovigilance System Master File (PSMF) is mandatory, must be located in Algeria, and registered with the ANPP.

• Incident Reporting (ICSRs):

  • Serious Cases: Report within 15 calendar days.

  • Non-Serious Cases: Report within 90 calendar days.

  • Emerging Safety Issues (ESI): Immediate notification required (max 5 working days).

• Risk & Periodic Reporting:

  • PSURs: Submitted in ICH-E2C(R2) format. Frequency: Every 6 months (first 2 years) → Annually (next 2 years) → Every 3 years.

  • RMPs: Mandatory for new authorizations and significant changes. Must include an "Algerian Presentation" annex.

• Signal Management: Validated signals must be notified within 45 days.

Summary of Requirements

Component	Requirement in Algeria
Regulatory Authority	CNPM / ANPP
Framework	Law 18-11 / Decree 19-379
Local Personnel	Mandatory QPPV (Resident Pharmacist)
PSMF	Required (Registered locally)
Serious ICSR Timeline	15 Days (24h for Emergency Use)
PSUR Frequency	6m / 1y / 3y
RMPs	Mandatory (+ Local Annex)
Submission Language	French / Arabic

https://youtu.be/zblbc-aEEew

 

Pharmacovigilance Guideline

In Algeria, the pharmacovigilance system is strictly regulated and mature, governed jointly by the Ministry of Health and the Ministry of Pharmaceutical Industry. The operational bodies are the National Center for Pharmacovigilance and Materiovigilance (CNPM) for technical monitoring and the National Agency for Pharmaceutical Products (ANPP) for regulatory oversight.

1. Clinical Safety (Clinical Trials)

• Expedited Reporting: While the provided text focuses on post-marketing, standard practice for clinical trials in Algeria aligns with international norms (ICH), requiring SUSAR reporting.

  • Fatal or Life-Threatening: Within 7 calendar days.

  • Other Serious Unexpected: Within 15 calendar days.

• Emergency Use: For products under emergency use listing, serious adverse events must be notified within 24 hours.

2. Post-Marketing Pharmacovigilance

Post-approval obligations are rigorous and require significant local presence.

• Personnel: A Local Qualified Person for Pharmacovigilance (QPPV) is mandatory. This person must be a Pharmacist (Doctor of Pharmacy) residing in Algeria and available 24/7.

• Documentation: A Pharmacovigilance System Master File (PSMF) is mandatory, must be located in Algeria, and registered with the ANPP.

• Incident Reporting (ICSRs):

  • Serious Cases: Report within 15 calendar days.

  • Non-Serious Cases: Report within 90 calendar days.

  • Emerging Safety Issues (ESI): Immediate notification required (max 5 working days).

• Risk & Periodic Reporting:

  • PSURs: Submitted in ICH-E2C(R2) format. Frequency: Every 6 months (first 2 years) → Annually (next 2 years) → Every 3 years.

  • RMPs: Mandatory for new authorizations and significant changes. Must include an "Algerian Presentation" annex.

• Signal Management: Validated signals must be notified within 45 days.

Summary of Requirements