International Air Transport Association
Airline trade association whose Temperature Control Regulations set the air-cargo rules for time- and temperature-sensitive healthcare shipments, and whose CEIV Pharma programme certifies pharma handling.
What this page does not claim
SPEQ curates and cross-references these bodies. It is not affiliated with, accredited by, or endorsed by any of them, and a count of decoded standards is a measure of SPEQ’s coverage, not of a body’s importance.
WHAT IATA COVERS
The International Air Transport Association (IATA) is the airlines' trade association, representing over 370 airlines that carry some 85% of global air traffic. For the GxP supply chain its relevant output is the Temperature Control Regulations (TCR), the manual of requirements for transporting and handling time- and temperature-sensitive healthcare products by air. The TCR covers shipper and carrier responsibilities, government and carrier variations, packaging, documentation and labelling, acceptance and control, traceability, and air-transport logistics. It is published annually: the 14th edition applies for 2026, and IATA has announced the 15th edition for 2027. IATA also runs CEIV Pharma, a certification for pharmaceutical handling across the air cargo chain.
WHAT IATA PUBLISHES
- 01Temperature Control Regulations (TCR), published annually (14th edition, 2026; 15th edition announced for 2027)
- 02The Time and Temperature Sensitive Label and its FAQ
- 03The acceptance checklist for time- and temperature-sensitive healthcare shipments
- 04CEIV Pharma certification for organisations in the air cargo supply chain
- 05Guidance on pharmaceutical logistics and distribution, including vaccine transport
HOW ITS REQUIREMENTS BITE
The TCR binds through the air-cargo contract. Airlines and ground handlers accept or reject a healthcare shipment against it, and individual airlines publish operator variations that add their own requirements. Two elements are mandatory: the Time and Temperature Sensitive Label, required since July 2012 on every shipment booked as time- and temperature-sensitive, and IATA's standard acceptance checklist, required since July 2013. CEIV Pharma is a voluntary certification of handlers' facilities, equipment, operations and staff. IATA is not a medicines regulator, so GDP obligations remain with the shipper.
What practitioners get wrong
- GDP sets the outcome, and the TCR is how the air leg is operated. A lane qualification that ignores the TCR and the carrier's operator variations has not qualified the flight.
- The label states the external transport temperature range. Booking a range the packaging was not qualified for creates a deviation before the shipment leaves.
- CEIV Pharma certifies a handler's capability, not a specific shipment, so supplier qualification still needs lane-specific evidence.
- Operator variations change between editions, and the 15th edition for 2027 updates several. Re-check carriers on the lane every year.
WHERE IT SITS INTERNATIONALLY
The TCR is the air-transport counterpart to the GDP texts that bind the marketing authorisation holder and distributor, including EU GDP, WHO guidance on time- and temperature-sensitive products and USP <1079>. IATA's Healthcare Cargo Working Group develops TCR amendments under the Live Animals and Perishables Board, and the TCR includes WHO vaccine references in its documentation and labelling chapter.
IATA STANDARDS SPEQ DECODES · 1
DISCIPLINES IN IATA’S REMIT
IATA: frequently asked questions
Reference answers on International Air Transport Association’s mandate, what it publishes, and how its requirements acquire force.
What are the IATA Temperature Control Regulations?
IATA's manual of requirements for transporting and handling time- and temperature-sensitive healthcare products by air. It covers responsibilities, packaging, labelling, acceptance, traceability and logistics. It is published annually; the 14th edition applies for 2026 and the 15th edition is announced for 2027.
Is the IATA Time and Temperature Sensitive Label mandatory?
Yes. Since July 2012 it must be affixed to every shipment booked as time- and temperature-sensitive cargo and must show the external transport temperature range. The shipper is responsible for applying it correctly.
What is CEIV Pharma?
IATA's Center of Excellence for Independent Validators in Pharmaceutical Logistics, a certification showing that an air-cargo organisation's facilities, equipment, operations and staff meet a globally consistent standard for pharmaceutical handling.