Photography: Comstock, Getty Images
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The key challenge clinical trial supply chain (CTSC) managers face in global distribution is ensuring that supplies arrive
at the trial sites on time and in good condition. Effective distribution requires a knowledge of regulations in the country
of origin and trial countries, qualified suppliers and storage infrastructure, and control of supply temperature and conditions
for the duration of delivery.
Regulatory compliance
Regulatory support is a critical aspect of clinical trial supply distribution, requiring the creation and control of essential
documents, study initiation, and activities to ensure a seamless supply of clinical materials. Another regulatory role is
labeling management, ensuring adherence to the labeling requirements of different countries, and managing the translation
of it.
When exporting clinical materials, CTSC managers must first ensure regulatory compliance with many government agencies in
both the originator and destination countries. In the United States, clearance is required from agencies such as the Food and Drug Administration, Department of Commerce,
Department of Homeland Security, and Drug Enforcement Administration (DEA), as well as state agencies to ensure that materials
are allowed to be delivered to destination countries, vendors, companies, and individuals, and that they are not on one of
the many government controlled sanction lists or embargo lists.
DEA-regulated supplies require additional clearances in the United States and abroad. Industry-specific computer software
is available to facilitate many of these functions.
Companies must also be knowledgeable about International Air Transport Association (IATA; http://www.iata.org/index.htm) regulations, which include guidelines for packaging and labeling diagnostic specimens. For example, shipments to Europe
can be made to one country within the EU and can then be freely circulated within the EU, subject to some minor exceptions.
The UK is commonly used as the EU port of entry since its importation requirements are often the least stringent.
All investigational supplies manufactured outside of the EU must be released by a registered Qualified Person (QP) for use
in European clinical trials. The QP is responsible for the compliance of imported supplies with European cGMP regulations
and guidelines.
Critical Forethought for Global Distribution
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Depending on the destination, the particular clinical trials materials, and how they need to be handled, global distribution
requires considerable preliminary work (see Table 1). Initially, the company must obtain import/export permits and other documentation
in compliance with the requirements of each country.
The CTSC manager should thoroughly review documentation to make certain it is accurate and complete. Every country has its
own unique terms, procedures, requirements, interpretations, and penalties, and each must be addressed individually. The risk
of noncompliance by even one company subsidiary can potentially jeopardize the import/export privileges of the entire corporation.
Shipping and logistics
Experienced CTSC managers and contractors have an established transportation and storage infrastructure, including vetted
third-party freight carriers and storage facilities, for efficient delivery. With a solid knowledge of shipping options and
current regulatory requirements, they determine the optimal distribution logistics:
- What are the most effective routes of transportation?
- Who are the most efficient, reliable freight couriers?
- Which freight courier is best for a particular shipment?
- What is the best way to coordinate shipping schedules and manage requirements for air, ocean, and ground transit?
- Which port of entry has the most efficient government customs clearance process?
- What special arrangements must be made for time-and temperature-sensitive supplies?
Distribution managers should also be knowledgeable about the unique regulatory requirements of each country.
Criteria Checklist
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China, for example, requires companies to make entry arrangements with a Chinese corporation that has a relationship with
the Chinese government. Otherwise, the supply may be delayed or the company may need to use a freight forwarder with a Class
A license. In India, the commercial invoice is stamped and becomes the import permit. For Israel, a pro forma invoice detailing
materials, use, and estimated cost is required for appropriate taxing. A common problem with less experienced supply chain
managers is the arrival of a shipment without all the required documentation. This can result in weeks-long delays at the
airport or depot, which can compromise the trial timeline and cause spoilage of temperature sensitive supplies. If there is
an extension or delay to the trial, and if supplies were manufactured before stability data was available, expiration dates
can also be a problem.
