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Israel is Evolving Into a Clinical Trial Powerhouse – BUT Understand the Regulatory Processes!

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By: Angus Macleod March 15 2017

Tags: Regulatory Import Export, Importer Of Record, Logistics for Clinical Trials

Clinical Trial Powerhouse

Israel is evolving into a clinical trial powerhouse. Its highly skilled workforce, adherence to Good Clinical Practice (GCP) and strong patient enrolment and retention rates make this a country of interest for clinical research. However, I have one top tip for you - when considering the best way to import clinical trial materials to Israel, making allowances for the regulatory approval process, is of paramount importance.

One key challenge is to understand the regulatory process when importing clinical trial material particularly the requirements governing the import and release of Investigational Medicinal Products. This is known as the Ministry of Health (MoH) Procedure EX-012 for the Manufacture and Import of Investigational Products in Israel.  Timelines have to be taken into consideration where it takes up to 6 days to release the product when it arrives at the Israel depot.

Another consideration relates to plastic versus wooden pallets. According to the Israeli Ministry of Health (MoH) requirements, products must be shipped and stored preferably on plastic pallets or if not possible on wooden pallets that were treated by heat only (according to International Standards For Phytosanitary Measures ISPM15 regulation).

Facilities will be able to receive wooden pallets which were disinfected by heat and not by Methyl Bromide. The pallet must be labeled with the relevant IPPC certification symbol. This includes the country code, who treated the wooden pallet and the treatment type. If these requirements are not adhered to, there is the prospect of the pallets being quarantined and valuable time is lost in releasing the clinical supplies.

Later this month Fisher Clinical Services will participate in the Outsourcing in Clinical Trials Israel conference, 21-22 March. Why not stop by our booth #8 to discuss your clinical trial needs in Israel? Contact us via email. We can share best practices with you!

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