Continuous refinement of Pharmacovigilance regulations in Arab countries

21st Nov, 2015


Continuous refinement of Pharmacovigilance regulations in Arab countriesPharmacovigilance (PV) significance and cognizance is constantly growing amongst pharma and biotech Industry, health care segments and masses at large. The Arab countries have also gained impetus and shown incessant refinement in gearing their countries towards attaining universal Pharmacovigilance observance goals. Beholding the regulations so far, Egyptian Drug Authority (EDA), Egyptian Pharmaceutical Vigilance Center (EPVC) has guidelines and legislations defined for a robust pharmacovigilance system.

Guideline Version Guideline Dates
Version 01 Egyptian Guideline On Pharmacovigilance for Medicinal Products for Human Use January 2012
Version 01 July 2012 (effective)
Version 01 GVP for Arab countries For Medicinal Products for Human use – Guideline for MAH March 2014
Version 02 December 2014
Version 02 1st July 2015 (effective)

Pharmacovigilance regulations are in place in Arab countries with effective implementation since mid-2015 to avail pharmaceutical products safety evaluation goals. These guidelines are to guide/direct Marketing Authorization Holders (MAHs) for establishing and/or maintaining global pharmacovigilance systems and assure adherence to pharmacovigilance compliance for a range of drugs and biologicals along with periodic benefit-risk monitoring and submissions.

EDA, EPVC have also provided the official regulations for MAHs in order to have:

  • QPPV or a concerned local safety responsible (LSR) person in place
  • Qualifications of QPPV/LSR
  • Post authorization ICSRs reporting time frames for pharmaceutical products (drugs and biologicals) for human use
  • Submitting PSUR (Periodic safety update report) and RMPs (Risk management plans) criteria for local and/or multinational MAHs
  • MAHs submitting list of products in their purview to regulate PSUR time periods
  • Emerging safety issues to be brought to Regulatory attention by immediate reporting
  • Actions pertaining to safety that might be (or have been) undertaken worldwide mainly where risk-benefit ratio is altered hugely

Timelines and reporting requirements/details along with legal framework are detailed in GVP for Arab countries guidance and the Ministry of Health legislations (in local language).

The Regulations have guidance documents to ensure that the MAHs pursue PV monitoring as a part of routine safety compliance.

Utilizing technology and IT intervention is exceptionally pivotal to have overall PV management and for the vast global reach of safety medicines monitoring esp. for the generic markets.

Technology can be leveraged to have:

  • Swift reporting of ICSRs online or a Gateway system
  • Rapid communication channel and interaction link between HCPs/reporters and MAHs or MAHs and Regulatory Authorities
  • Literature surveillance at a significantly higher speed than conventional manual search
  • Minimal data entry, system checks & validations as per standard norms/business rules
  • Managerial and analytical approach for escalating productivity and generating long periodic reports
  • Assisting for reporting signal detection tools in a voluminous database
  • Adherence to guidelines and the structured format for uniform reporting worldwide e.g., XML (Extensible Markup Language) format

In pharmacovigilance, a regulatory-driven industry with the dynamic pace of norms being updated and revised, mechanization is the key to sustain compliance.

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