Quote from VigiServe Admin on November 29, 2020, 6:55 AM

In Israel, the pharmacovigilance system is regulated by the Ministry of Health (MoH) and is closely harmonized with EU Good Pharmacovigilance Practices.

1. Clinical Safety (Clinical Trials)

Clinical trials require MoH approval and adhere to ICH GCP standards.

• Expedited Reporting: Sponsors report Suspected Unexpected Serious Adverse Reactions (SUSARs).

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

  • Other Serious Unexpected: Within 15 calendar days.

• Periodic Reporting: Development Safety Update Reports (DSURs) are required annually.

• Submission: Direct submission to the MoH via electronic channels or forms.

2. Post-Marketing Pharmacovigilance

Marketing Authorization Holders must maintain a pharmacovigilance system compliant with MoH Procedure No. 6.

• Personnel & Infrastructure:

  • Local Qualified Person for Pharmacovigilance: Mandatory. A licensed Israeli pharmacist or physician with at least two years of experience must serve as the 24/7 contact.

  • Pharmacovigilance System Master File: Required. The file must be detailed and available for MoH inspections.

• Incident Reporting (ICSRs):

  • Timelines:

    • Serious: Within 15 calendar days.

    • Non-Serious: Within 90 calendar days.

• Risk & Periodic Reporting:

  • Periodic Benefit-Risk Evaluation Reports: Mandatory. Typically submitted every six months for the first two years, then annually.

  • Risk Management Plans: Mandatory for new, high-risk, or biologic products.

Summary of Requirements

Component	Requirement in Israel
Regulatory Authority	MoH (Ministry of Health)
Framework	Procedure No. 6 / EU Harmonized
Local Qualified Person for Pharmacovigilance	Yes
Pharmacovigilance System Master File	Yes
Safety Reporting	15 days (Serious) / 90 days (Non-Serious)
Clinical Reporting	SUSARs (7/15 days)
Submission Language	Hebrew / English