What Are Advanced Therapies and CAR-T Treatments?
Advanced therapies — including cell and gene therapies (CGTs) such as Chimeric Antigen Receptor T-cell (CAR-T) therapies — represent a major leap forward in modern medicine. These innovative, patient-specific therapies are designed to use living cells to repair or replace damaged tissue, treat cancers, and in some cases, even cure diseases that were once considered untreatable.
Each therapy is manufactured for a single patient and must be delivered within precise time and temperature parameters to maintain its viability. A delay or deviation at any stage can make the treatment unusable, underscoring the critical importance of reliable logistics, regulatory compliance, and technical expertise.
Why CAR-T Logistics Require Extreme Precision
CAR-T products are highly temperature-sensitive, requiring deep-frozen or cryogenic conditions—often at temperatures below –150°C—to preserve cell function. From the moment a therapy leaves the production site until it reaches the hospital, it must remain in a strictly controlled environment.
These are not routine shipments; they are life-saving deliveries where every detail matters. Selecting a logistics partner experienced in managing such shipments is essential to ensure the product’s integrity, safety, and traceability.
IMP’s Expertise in Importation and Remote QP Release
At IMP Clinical Supply Services, we specialize in the importation of advanced therapy products into Israel. Our team manages the end-to-end import process, ensuring that CAR-T and other cell and gene therapy shipments are delivered directly to the treating hospital under full regulatory compliance.
When required, Qualified Person (QP) release can be performed remotely, providing flexibility and continuity of oversight without delaying patient treatment. IMP has successfully coordinated remote QP releases for several years, helping streamline access while maintaining the highest quality standards.
Israel’s Regulatory Requirements for Advanced Therapies
The regulatory framework for advanced therapies continues to evolve in support of clinical and patient needs.
Recently, the Israeli Ministry of Health confirmed that CAR-T shipments that are part of clinical trials will be exempt from VAT, recognizing their unique status as life-saving, patient-specific products and aligning Israel with global practices that facilitate the delivery of advanced treatments.
In addition, importers must comply not only with clinical trial labeling requirements but also with the Advanced Therapy guidelines and labeling instructions set out in Procedure EX-022. IMP’s regulatory team ensures that every shipment meets these dual standards, from documentation through labeling and delivery.
Ensuring Safe, On-Time Delivery for Life-Saving Treatments
Handling advanced therapies requires more than logistical capacity — it demands precision, reliability, and experience. IMP Clinical Supply Services combines technical know-how, regulatory expertise, and dedicated coordination to ensure that every shipment reaches its destination safely, compliantly, and on time.
Through this work, we are proud to play a part in bringing cutting-edge therapies to patients in Israel, supporting both clinical research and the future of personalized medicine.
Contact us to learn more about importing advanced therapies into Israel.