How deep is the water for imported atropine?

In the late-night emergency room, Mr. Zhang fell into a coma due to pesticide poisoning, and the doctor quickly injected an ampoule of atropine injection - this seemingly ordinary glass ampoule is a "life relay" that has traveled tens of thousands of kilometers from overseas laboratories to Chinese hospital pharmacies. As a golden member among emergency drugs, what is the industry secret behind the import agency of atropine? Today, we will unveil this mystery.

As a first-line antidote for organophosphorus poisoning, the purity requirement of the raw material drug of atropine reaches as high as 99.97%. Some domestic manufacturers, due to production process limitations, are difficult to stably meet the certification standards of the EU EDQM or the US FDA. Ms. Li from the pharmacy department of a tertiary hospital revealed: "The bioavailability difference of imported atropine in emergency scenarios can reach 15%, which is crucial for life-saving efforts in every second."

• Special dosage form requirements: Innovative dosage forms such as prefilled syringes are mostly developed by foreign companies
• Emergency reserve gap: Domestic production capacity may be insufficient during public health emergencies
• Challenges of cold-chain transportation: Some preparations require temperature-controlled transportation at 2-8℃ throughout the process

The First Barrier: Breaking Through the Qualification Maze It is necessary to simultaneously obtain the Imported Drug Registration Certificate, Medical Device Business License, and Special Drug Business Qualification. Professional agencies such as Zhongshitong usually need to start the filing process 18 months in advance.

The Second Barrier: The Extreme Challenge of Cold-chain Logistics During the transportation from the German factory to Shanghai Port, the temperature recorder generates 1 set of data every 30 seconds, and any exposure above 8℃ for more than 15 minutes will lead to the rejection of the entire batch.

The Third Barrier: The Special Pass of Customs Emergency drugs can take the "green channel", but the following need to be prepared:

• Notarized document of GMP certification in the origin country
• Purchase intention letter from a tertiary hospital
• Emergency use approval document from the National Medical Products Administration

Since 2023, some leading institutions have begun to use blockchain technology: Scanning code for traceability can view the full-life-cycle data of the drug from raw materials to distribution. Intelligent early warning system automatically monitors inventory and expiration dates in various places. Electronic customs clearance reduces the document approval time from 7 days to 8 hours.

When an emergency ambulance rushes by late at night one day, perhaps it is the information you have learned today that allows the pillar of a certain family to continue to see the sun tomorrow. Regarding the import of emergency drugs, how do you think the approval efficiency and quality supervision should be balanced? Welcome to leave your insights in the comment section.