Pharmaceutical Packaging

Pharmaceutical Packaging refers to packaging materials, containers, and systems used for drugs, including primary packaging that directly contacts the drug (such as vials, blister packs, ampoules) and secondary packaging (such as cartons, package inserts, labels). In foreign trade, this term emphasizes compliance with regulations such as Good Manufacturing Practice (GMP), the U.S. Food and Drug Administration (FDA), or the European Medicines Agency (EMA), and must meet characteristics such as moisture resistance, light protection, sterility, and child safety. Usage scenarios are commonly found in pharmaceutical export contracts, purchase orders, technical specifications, and customs declarations. Notes: Exporting to the EU requires compliance with the Guideline on Pharmaceutical Packaging Materials, and the U.S. requires submission of a Drug Master File (DMF); packaging changes may trigger registration updates. The difference from ordinary 'packaging' is that pharmaceutical packaging is strictly regulated and often involves stability testing and compatibility studies. Foreign trade practitioners should pay attention to whether suppliers have ISO 15378 certification and clarify the responsibility attribution of packaging materials.