What are the new Israeli adverse event and safety requirements issued in August of 2012 and how do they affect the pharmaceutical industry?
The drug license holder is obliged to assign a pharmacist Qualified Person for Pharmacovigilance (QPPV) and to implement a system for tracking and evaluating adverse events (AEs) and new safety information for each pharmaceutical product.
Reporting to the Health Ministry:
Reports must be submitted within 15 days through the Assigned Pharmacist by the QPPV on:
- Every new notification that relates to pharmaceutical product safety published by the FDA, EMA or the authority that issued the Certificate of Pharmaceutical Product (CPP)
- New safety information that was published in English professional or scientific literature
- New information from safety reports issued by the manufacturer or license holder
- A deviant AE for which there is suspicion that the AE frequency is higher than known levels
- One or more serious AEs discovered in Israel, that:
- Are suspected to have caused death, paralysis, severe limitations or life-threatening conditions
- Required significant medical care
- Caused a birth defect when the drug was taken during pregnancy
- Caused the problems stated above regardless of whether they were reversible
- Adverse events, lack of efficacy, toxicity of a new medicine formulation in Israel that was discovered during the first 12 months of drug marketing in Israel
- AEs that were reported in Israel that were not documented in the Israeli physician prescribing information, or Summary of Prescribing Characteristics (SPC)
Monthly reporting – reporting on adverse events with deviation in frequency
The Assigned Pharmacist or QPPV must perform a monthly review of AE reports relative to usage or sales information, and report to the Ministry of Health if there was an increase compared to the recent year in Israel or international data.
Periodic Safety Update Report (PSUR)
The Assigned Pharmacist or QPPV must submit to the Health Ministry a summary report and conclusions from the periodic safety report regarding every pharmaceutical product, just as the international authorities require. This information must be submitted with a signed declaration after reviewing the complete report.
The Assigned Pharmacist or QPPV must verify that the report is valid and contains the details required according to EU good Pharmacovigilance practices (GVP).