Nanjing Customs recently set up a risk assessment center for "special articles" in Taizhou city, in East China's Jiangsu province – making it the third city in the region to have such a center.
The term special articles refer to microorganisms, human tissue, biological products, blood and their products.
On the day of its establishment, three vaccine producers in Taizhou completed a risk assessment on the spot of the strain/antigen bioassay reference required for the production of an influenza vaccine.
"In the past, it had to be carried out in Nanjing or Suzhou," said Ye Yaping, an employee of a Taizhou-based biotechnology company.
"Now we were able to complete it locally, which greatly shortened the time of risk assessment and improved the speed of the customs clearance," Ye added.
As Taizhou's health industry develops rapidly, the most demand for the importation of influenza virus strain/antigen biological detection reference materials from enterprises across the province comes from Taizhou.
In 2021, Nanjing Customs completed 32 batches of risk assessment for such materials – including 27 batches from Taizhou, accounting for 84.4 percent of the total.
China requires the supervision and management of health and quarantine of entry-exit special goods to follow the principle of risk management – and that those responsible implement quarantine approvals, quarantine inspections and supervision management according to the risk level.
High-risk special goods entering and leaving the country must be declared to customs and be subject to risk assessment. After passing the assessment, a special goods approval form can be applied for and then the customs clearance formalities will be processed.
"The production, sales and marketing of the influenza vaccine are highly seasonal and time-sensitive," said Qiao Hualin, deputy director of Taizhou Customs.
"The import time needs to be determined according to the recommended strains released by the World Health Organization in the current year, which cannot be accurately estimated and enterprises need to wait for a long time if they miss the risk assessment," Qiao added.
Compared with the past, enterprises in Taizhou will now carry out the risk assessment on the biological test reference of influenza antigen to be imported locally.
This is expected to not only save time and costs, but also allow local experts to become more familiar with the enterprise and the whole process to be smoother – helping the businesses to develop an influenza vaccine more quickly, Qiao added.