A batch of special biological products no longer need to repeat the risk assessment many times, nor is it a long-term inspection and passage waiting, only need to dock a window to get the application license "one-time", and after the rapid customs clearance and release, you can "cross the ocean" to enter the laboratory ......
Soon, such a scene will become the norm in the new area, and the development of the life and health industry will be smoothed a "fast lane". Behind this is an innovative service enterprise initiative.
In January, Nanjing Customs and the people of Nanjing jointly issued an announcement to decide to establish a new area in Jiangbei New AreaPilot the implementation of a joint supervision mechanism for entry-exit special items. The new area also optimized the work plan for the first time, and held the first meeting of the multi-departmental joint supervision mechanism for special items entering and exiting the new area and a symposium on key biomedical enterprises to listen to the actual needs of enterprises face-to-face and collide with enterprises on better service measures.
Special items refer to human tissues, microorganisms, blood and their products, biological products, etc., which may have the risk of various infectious diseases and require strict import and export supervision.
On the other hand, these special items are indispensable "raw materials" for the development of new drugs. Especially in Jiangbei New Area, where more than 1,000 enterprises in the field of life and health are gathered, with the strong rise and rapid development of the industry, the planned import volume of special items by enterprises in the park is also "rising".
Enterprises hope that "the sooner the better", how to solve the problem of "service enterprises" article?
As early as March 2020, a new area was built around the facilitation of customs clearance for special biomedical itemsCentralized supervision and public service platform for biomedicine. Improve the efficiency of customs clearance by simplifying the approval process, implementing centralized supervision, and assisting the Customs in organizing risk assessment meetings for high-risk special items.
Since the operation of the platform, a "green channel" has been opened for enterprises: the approval of the import of biological products such as small molecule drugs, blood and their products has been shortened from the original 20-30 working days to the fastest 1-3 working days; The risk assessment meeting has also been held 16 times, and 272 enterprises have participated in the risk assessment, involving 922 products, and the product pass rate has reached 9436%。
Behind these numbers, there is a surge of innovation. However, in the answer sheet of customs clearance facilitation for special items, the new area is still breaking through.
According to the relevant person in charge of the Investment Promotion and Commerce Bureau of the New District, the joint supervision mechanism for entry-exit special items implemented in this pilot project is the management mode of "enterprise biosecurity control system assessment + comprehensive assessment and approval before entry + follow-up supervision by various departments after entry" for special items.
This means,The "siloed" of multiple regulatory authorities has shifted to more efficient "co-governance". With credit risk management as the core, it is also to lower the entry threshold in advance and let special items".Enter, pass quickly, and manage
We also undertake testing business internationally, and we need to import a lot of blood samples every year. In recent years, the company's overseas market has further expanded, and the demand has become larger. Jiang Siming, deputy general manager of Shihe Gene, said, "The new mechanism of 'one-stop' solution to problems and the reduction of intermediate links will greatly improve our customs clearance efficiency, which is also the key for us to sail to the sea and promote China's advanced biomedical technology to the world." ”
The implementation of the new mechanism will save a lot of steps and time for our work, and we can quickly get the materials we need, which has some advantages in the competition with foreign counterparts. Pei Bo, vice president of Beiheng Biotechnology, also sent a thumbs up.
From the centralized supervision and public service platform to the joint supervision mechanism for entry and exit special items, this is another bold and bold attempt of the new area. It is not limited to solving problems for enterprises with policies and measures, but to facilitate enterprises with institutional innovationIndustrial development has also gained new impetus.
Before a new mechanism can be implemented, it also needs to be "tested" by enterprises.
I just want to listen to the most real needs of business friends, so that the system can be better implemented, and really become everyone's helper. ”
Not long ago, the first meeting of the multi-departmental joint supervision mechanism for entry and exit special items in the new area and the symposium on key biomedical enterprises were held. It is understood that the new area will quickly carry out the review of the first batch of pilot enterprises according to the needs of enterprises.
In addition to the multi-departmental joint supervision mechanism, at the end of January, the new area also announced a pilot plan for the "white list" system for the import of biomedical R&D items. Focusing on import facilitation, the import of items on the "white list" will not need to go through the "Customs Clearance Form for Imported Drugs", so as to help the industry advance with institutional innovation.
Prior to this, the new area also built the "Ningyantong" reference preparation service platform. Many measures are accelerating the facilitation of customs clearance, and on the basis of intimate services, the business environment of the life and health industry in the new area is also constantly optimized.
Material** Investment Promotion and Commerce Bureau.
Text |Zhou Qin, Gao Yuan.
Publish |Zheng Hao.
Audit |Liu Yuntao.