|Aesica's facility in Pianezza, Italy--Courtesy of Aesica Pharmaceuticals|
The U.S. is not the only country requiring drugmakers to begin serialization of products to make them easier to track through the supply chain. China has also established new rules to protect its pharma supply from counterfeiting and allow for faster recalls. But the government shortened the time frame for meeting them, forcing drugmakers and contractors to scramble to catch up.
Contract developer and manufacturer Aesica Pharmaceuticals says a plant in Italy--makes multiple products but only two are affected by Chinas serialization regulations. With new equipment--it is prepared for the requirements. "Major changes are happening in product serialization and tracking regulations across pharmaceutical markets worldwide and China is a prime example of this," said Maurizio Beninati, IT manager at Aesica Pharmaceuticals S.r.I.
He said that new software at plant in Pianezza allows the company to identify individual packaging down to the smallest sellable unit sizes and aggregate the unit serial numbers as packages are consolidated onto shipping pallets. Then the CDMO can pull reports for government regulators or track a product that needs to be recalled.
China is believed to be the source of a large amount of the counterfeit drugs that infiltrate the global supply chain and its oversight has often been criticized as weak and ineffective. But China's State Food and Drug Administration (SFDA) has set out new rules and a three-year plan that put it ahead of many other countries, including the U.S., in terms of implementing track and trace systems. Last year China established requirements that companies use bar codes, electronic monitoring and standardized documentation to trace drugs through the supply chain, with full implementation beginning next year.
Europe, Brazil and the U.S. all have timetables to roll out drug tracking capabilities. The U.S. last fall passed the Drug Quality and Security Act. There are different players in the mix, and they face different deadlines for meeting requirements, but beginning next year, pretty much everyone must be able to track drug lots of prescription drugs. Two years later, the industry must begin assigning serial numbers to individual "saleable units" of every prescribed product sold in the U.S.
- here's the Aesica release
Editor's Note: The story was updated to indicate that the facility in Pianezza makes multiple products but only two are currently affected by serialization.