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Exporters rush to meet Chinese FDA serialisation requirements

By Fiona BARRY , 26-Jun-2014
Last updated on 26-Jun-2014 at 14:10 GMT

Pharmaceutical companies are rushing to respond to shortened deadlines from China’s Food and Drug Administration (CFDA) for serialising drug packaging.

The Italian division of contract development and manufacturing organisation (CDMO) Aesica has launched a serialisation system from software makers QAD to meet Chinese deadlines, cut from 12 months to three.

Maurizio Beninati, IT Manager for Aesica’s site in Pianezza, Italy, told Outsourcing-Pharma.com pharmaceutical customers shipping to China began requesting serialisation ahead even of the March 2014 deadline, to make sure they did not run out of viable stock.

‘Strange’ regulations

The CFDA requires serialisation only for certain controlled pharmaceutical imports on its National Essential Drug List (NEDL). The process requires three steps: serial numbers must be placed on the product packaging, the shipping box and the pallet.

The particularity of Chinese serialisation is that China is one of the only regions which pre-assigns the serial code, so this means you have to ask the Chinese government to send you the needed codes to serialise the products,” said Beninati.

They don’t want external codes. Because they have central serialisation code management, they want to make sure that each code released for the product is present in Chinese database. As soon as a product arrives at country, they check that this code is present in the database.

The other strange thing is they decided to use a linear barcode, not a data matrix or a simple small 2D code – we are talking about a 20-digit code. This is another big problem if your packaging is really small – in this case you have to change your artwork because you have to leave one face of your presentation blank for the code.

All documentation is released in Chinese, a situation that “could be simpler” and can add to bottlenecks, said Beninati.

Next: Korea and Argentina

Aesica’s Pianezza plant equipped two existing lines for Chinese serialisation – one for lipid form oral solutions, and the other for solid form drugs – with new stations for track-and-trace and tamper-evident stickers, another requirement from China.

Aesica has been using the QAD Enterprise Application since September as a beta test. The software will come on to the commercial market at the end of the year. The serialisation system is able to receive external code from another system (in this case the CFDA) as well as generate its own, as is standard.

The coming months will see other countries enforcing serialisation deadlines on imports, notably Argentina and South Korea early next year. Aesica has begun working with customers shipping to these countries, Beninati said.  

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