Welcome to our first monthly blog.
Regulatory and Quality guidelines in Israel are being politically highjacked by the non-FDA approved Israel decision to recommend over 60s to have third Covid vaccination.
The decision to ignore our local MoH strict guideline that all clinical use requires pre-approval by FDA or EMA, has the long-term potential of de-stabilising our local regulatory approval system.
In my opinion, the long-term implications of politicians meddling withing our local drug approval system require careful monitoring.
Timeframes for local drug licensing are still too-long.
Total duration from initiation of local registration until product available on pharmacy shelves is three-four years.
The background is:
- Manufacture priority for supply of updated consolidated dossier for Israel with all required local documentation
- Israel MOH substantial delays in dossier review and extended post registration process for preparation of leaflets and graphics, ending with a first batch submission.
- Lastly a majority of manufacturers are now requirement software upload of all packaging materials in three languages.
Manpower shortages: regulatory and quality systems require specialised manpower. lack of trained and experienced personnel encourages instability and creates extended durations for initiation of new projects. lack of manpower flexibility delays projects.