Anticipating Challenges in CGT Cross-Border Transport

Cell and gene therapies (CGTs) are a rapidly growing area of study, ushering in new possibilities for treating life-threatening diseases and genetic conditions. As the use of these therapies increases, and global clinical trials for them proliferate, it becomes increasingly complicated to navigate their logistical intricacies. 

One central concern is how to transport medicines, including investigational medicinal products, to health organizations and trial sites in various countries. This blog will explore several key challenges and considerations for the cross-border transport of CGT components, including regulations, preclearance, and the designation of an importer of record.

Knowing the regulations

Every country has its own unique, often stringent, regulations that need to be thoroughly understood, so that medical products can be successfully imported. Ensuring compliance and avoiding costly delays requires advanced logistical planning and a thorough knowledge of the import requirements of each participating country. For instance, there may be regional differences in the documentation, labeling and packaging requirements, or in the classification of a medical product. 

Additionally, regional and national regulations can change quickly, as new approaches to medicine develop, and as the political landscape shifts. For instance, CGTs are still a relatively new form of medicine, and as a result, regulations in many places are still adapting to manage them. 

Further, some genetically modified organisms — a category which includes CGTs — are classified as dangerous or hazardous goods by certain regulatory bodies, such as the United Nations, who impose additional transport regulations, including packaging, surcharges, and restrictions. The United States (U.S.) and the European Union (EU) have strict requirements for CGT import, while regulations in developing nations are still rapidly evolving. Staying abreast of such shifts, and adjusting to accommodate them, is critical to any cross-border transport. 

Preparing for customs

Timely delivery of medicines is important, particularly in the case of temperature-controlled products, such as CGTs or other biologics. For such medical products, delays or interference caused by customs inspections at international borders can prove catastrophic, with the potential to cause temperature excursions that render the medicines no longer viable. Because of this, those transporting CGTs must make every possible preparation to limit any delays. Often, this takes the form of ensuring that customs payments and the necessary paperwork are provided beforehand, so that the lack of these does not provide reason for a shipment to be held up.

In select countries, preclearance of goods is possible to further expedite transport through customs. This process allows for the electronic submission of documentation and the necessary filing for clearance before arriving at customs. Additionally, the preclearance process for some countries also allows officials at key locations to examine and verify cargo within a host country before those goods reach the border. The use of preclearance enables the minimization of delays and the reduction of overall transit time. Such preclearance programs have been introduced between the U.S. and Canada, as well as between the U.S. and Mexico, and among other countries. It’s essential to know which nations employ these preclearance tools during logistical planning and make the best use of them before transporting medical products.

Designating importers of record

Due to the strict regulation of CGT import in many places, a knowledgeable importer of record (IoR) can be a true asset to smooth the process of cross-border transport. The IoR is responsible for ensuring goods comply with customs and legal requirements of the country they are entering and leaving, and will, generally, be the representative in communication with customs authorities to provide any necessary additional information or address any issues. The designation of an IoR is required for the import of medical products to many countries.

Depending on the country, an IoR can be one of a variety of stakeholders, such as the sponsor of a clinical trial, or the owner or purchaser of the medical product. Some countries allow the appointment of a third-party IoR, such as a logistics provider, whose global customs experience can streamline the process and reduce supply chain risk. Because of the role the IoR takes in coordinating a shipment — such as paying customs fees and taxes, maintaining proper documentation, and, in the case of a clinical trial, submitting the trial to the local ministry of health — it becomes crucial that the selected individual is well versed in the requirements of import for all localities involved in CGT transport. 

Planning with experience

One of the best ways to set your endeavor up for success is to lean on expert biopharma logistics coordinators, such as Yourway’s, who have experience with transport to the destination country. Additionally, Yourway’s local staff, who are in communication with the relevant agencies, can help with staying up to date on the current regulations and requirements, along with any pertinent changes. Ultimately, as in many enterprises, successful CGT cross-border transport comes down to knowing what to expect, and being prepared as far in advance as possible. In the interest of sharing our expertise and setting your clinical trial up for success, Yourway has written a whitepaper on the impact of integrated logistics on CGT clinical trials.

To learn more about CGT logistics, read Yourway’s whitepaper, or get in touch at info@yourway.com.