Importing Investigational Medicinal Products (IMPs) and medical supplies for clinical trials is a complex and highly regulated process. Unlike standard commercial imports, clinical trial importation involves unique regulatory and logistical challenges that require specialized expertise. At IMP, we ensure a seamless and compliant importation process, working closely with regulatory authorities, customs officials, and shipping providers to avoid delays and compliance issues.
Understanding the Importation Process for Clinical Trials
Importing pharmaceuticals and medical devices for clinical trials requires compliance with strict regulatory frameworks. Each shipment must meet customs requirements, regulatory approvals, and QP release standards before reaching trial sites. Here’s what makes clinical trial importation unique:
- Customs & Documentation Compliance
Before an import can be processed, all supplier invoices and shipping documents must be carefully reviewed to align with customs and regulatory requirements. At IMP, we meticulously verify and amend invoices where necessary to prevent issues at customs clearance. - Import Permits & Regulatory Approvals
Unlike standard imports, investigational drugs require specific pharmaceutical import permits, which may be issued on a one-time or periodic basis by the Israeli Ministry of Health. Each product type—whether it’s an investigational drug, medical device, ancillary equipment, or lab supplies—might necessitate additional regulatory clearance from the relevant authorities. At IMP, we ensure that all necessary permits and approvals are obtained efficiently, so that your clinical trial shipments comply with all regulatory requirements. - Importation of Controlled Substances & Compassionate Use Treatments
Some trials involve cannabis, narcotics, or compassionate-use therapies, which require specialized permits and coordinated approvals to ensure compliance with controlled substance regulations. - Ongoing Communication with Authorities & Logistics Providers
Ensuring a smooth import process requires constant coordination with customs authorities and courier services to prevent delays and facilitate timely delivery. At IMP, our team works proactively with these entities to handle any issues before they impact the trial timeline.
Ensuring Compliance: QP Release & Final Distribution
Since a regulatory update in 2013, it has been prohibited to import pharmaceuticals directly into hospitals or pharmacies in Israel. Instead, all imported medicinal products must first be processed through a licensed pharmaceutical wholesaler, where they undergo QP (Qualified Person) or QA (Quality Assurance) release before being distributed to clinical trial sites. However, in special cases—such as CAR-T therapies and others—waivers may be granted by the Ministry of Health. IMP has extensive experience managing direct-to-site importation when such waivers are in place.
Expert Importation Solutions with IMP
With our deep regulatory expertise and strong industry connections, IMP ensures seamless importation for clinical trials, minimizing risks and avoiding costly delays. Our team handles every step—from obtaining permits to coordinating with customs and regulatory agencies—so you can focus on advancing your research.
Need assistance with clinical trial importation? Contact us today to discuss your needs.
📩 Get in touch: [email protected]
📩 Get in touch: [email protected]