At the end of last year, the Municipal Food and Drug Administration, Municipal Science and Technology Bureau, Municipal Commerce Bureau, Tianjin Customs, and Tianjin Pilot Free Trade Zone Management Committee jointly issued the "Tianjin Biomedical Enterprises (R&D Institutions) R&D import Pilot Program", innovative The "white list" system was launched, and it was the first to be implemented in the Tianjin Pilot Free Trade Zone.
In the past two days, the Tianjin Pilot Free Trade Zone will usher in the first batch of imported drugs on the "white list". "The first batch of companies entering the 'white list' include Tianjin WuXi AppTec and Medratech, involving two items such as dextran and heparin sodium. It is 5,000 grams." Cao Zhengqing, deputy director of Tianjin Free Trade Zone Innovation and Development Bureau, said that although the overall import volume is not large, it is of great significance to the research and development of biomedicine in this city.
What is the "white list" system? Why are drug supervision, technology, free trade and other departments "circling" when hundreds of grams of "trace" R&D supplies are imported? Where is the innovation of the "white list" system? Recently, reporters interviewed relevant companies and departments with questions to find answers.
Crack the "pain" point of industry research and development
It is understood that for a long time, when some research and development items have been through customs clearance procedures at the customs, because the commodity numbers are included in the "imported Drug Catalog", they need to submit the "imported Drug Clearance Form" to the customs, but according to the current national policy, some research and development items are not issued. The situation of the "imported Drug Customs Clearance Form" has resulted in the inability to pass customs clearance, which has become a "bottleneck" restricting the research of new drugs.
Taking WuXi AppTec as an example, as a preclinical drug research institution engaged in CDMO, the problem of importing research and development materials has long caused problems for the company in terms of project design, research and development direction, and material selection. "It turns out that some R&D raw materials need to apply for import approval according to the principle of commodity classification. Take the customs clearance form for imported drugs (supervision code: Q certificate) as an example. In the past, similar situations have been encountered. Because these products are not listed drugs, the certificate cannot be successfully obtained. imports will affect the progress of research projects.” said WuXi AppTec’s operations director.
There are also other biomedical companies in the new area who have the same trouble. "Before the 'white list' was issued, some of our key reagents for R&D could not be imported due to their particularity, resulting in the lack of raw materials for R&D, which affected the progress of R&D projects." The person in charge of Metrotech said frankly.
Enterprises throw out the problem, how can the Tianjin Free Trade Zone take it steadily and make the enterprise more confident in its development? Cao Zhengqing said, "After investigating and understanding that biopharmaceutical companies are limited by the relevant regulations on the import management of biomedical R&D materials, which affect the company's R&D process, the Innovation and Development Bureau of the Free Trade Zone and relevant municipal departments formed a working team Research and formulate a biomedical 'white list' system, establish a 'white list' of biomedical pilot enterprises and items in this city, and then fill in the gaps in supervision, solve the import blockage of enterprises and simplify the relevant pre-approval procedures to facilitate customs clearance for enterprises."
Policy dividends stimulate innovation vitality
So how does the "white list" system break through the policy blockage? It is understood that, according to the pilot program, biopharmaceutical companies (R&D institutions) will replace the "imported Drug Customs Clearance Form" with the "White List" certification documents to go through the import declaration and inspection procedures at Tianjin Customs. The "white list" identification documents can be accumulated and used for customs declaration in batches within the approved import quantity.
At the same time, the pilot plan clearly states that the "white list" system consists of two parts: pilot enterprises and pilot items, and each pilot enterprise needs to correspond one-to-one with the pilot items. The first batch of pilots include biopharmaceutical enterprises (R&D institutions) in the Pilot Free Trade Zone and the Tianjin Pharmaceutical Manufacturing Foreign Economic and Trade Improvement and Efficiency Demonstration Project; or accessories.
With the implementation of the "white list" system, it not only breaks through the "obstruction" that hinders the long-term development of biomedicine, but also feeds back the industry itself with an innovative industrial ecological environment. According to the first batch of companies entering the "white list" this time, after the implementation of the "white list" system, companies are exempted from importing Q certificates and can import research and development supplies smoothly. At the same time, the research and development progress continues to accelerate, and it provides great convenience for product conversion. "After the 'White List' is passed, it will solve the worries of our R&D companies and further enhance the competitiveness of domestic companies' R&D services. At the same time, it will be easier to integrate with international standards for similar products and further expand the scope of services." WuXi AppTec's operations director said.
According to Gong Ailong, deputy director of the New Economy Center of the Tianjin Free Trade Zone Innovation and Development Bureau, the "white list" system solves the problem that some research and development items cannot be cleared, fills the gap in the relevant regulatory system, and makes Tianjin's biomedical customs clearance convenience reach the domestic leading position The level is conducive to the operation of the enterprise, the real realization of cost reduction and efficiency increase, and the improvement of the overall operational efficiency. At the same time, the "white list" system speeds up the normal testing and listing of drugs, reduces the cycle of drug research and development, and greatly improves the efficiency of research and development. At the same time, a joint promotion mechanism is established to provide strong support and all-round services for biopharmaceutical companies and drive the high-quality development of the biopharmaceutical industry. and reform of government functions.
Introducing more innovations in the future
At present, the "white list" system has been launched for more than five months. How is the overall progress? "The 'white list' system was released at the end of 2022, and immediately entered the stage of enterprise registration and evaluation. The first batch of 'white list' was finalized in March this year, and the first batch of imported drugs on the 'white list' was ushered in in May." Cao Zhengqing Said that this time, there are two varieties of items with two product specifications included in the "white list", which has achieved a breakthrough in both type and quantity.
It is understood that since the implementation of the "white list" system, the Tianjin Free Trade Zone has continued to increase policy publicity and provide targeted services for enterprises. Continue to deepen the pilot project of importing biomedical R&D items, expand the implementation scope of the "white list" system, and gradually expand the categories of R&D items. Of course, you can let go only if you can get in and control it. Currently, the city implements dynamic adjustments to the "white list". At the same time, the pilot plan also clarifies that the items included in the "white list" are only for the corresponding biopharmaceutical companies on the list to carry out R&D work in strict accordance with the application purposes, and no sale, gift, exchange of imported items, or other changes in the ownership and use of pharmaceutical R&D items are allowed. the behavior of. "The interim and ex-post supervision methods of the 'white list' system guide enterprises to better implement their main responsibilities and improve the level of risk prevention and control." Cao Zhengqing said.
In addition to the "white list" system, the Tianjin Free Trade Zone has also continuously launched innovative measures to comprehensively improve the innovation and development level of the biomedical industry. During the period, the Tianjin Free Trade Zone promoted the construction of clinical urgently needed imported medicine and equipment channels, promoted the expansion of pilot green channels for clinically urgently needed imported drugs, and increased drug categories and pilot medical institutions in a reasonable and orderly manner. At the same time, continuously optimize the customs clearance mechanism for special items and improve the efficiency of special item approval. Promote the construction of a biomedical supply chain platform, and continue to expand public service functions such as supply chain docking and achievement transformation. Carry out reform pilots in the field of gene and cell therapy, and take the lead in trying "risk classification, access classification" management.
"In recent years, the Tianjin Free Trade Zone has continued to deepen the system integration and innovation of the entire biomedical industry chain and promote breakthroughs in the field of biomedicine." Cao Zhengqing said that in the future, the Tianjin Free Trade Zone will also launch more "small cuts, quick results" products The reform measures will break through the blocking points of the biomedical industry and solve the pain points of enterprises, thereby promoting the continuous improvement of the research and development capabilities of the biomedical industry in Tianjin Free Trade Zone, stimulating the vitality of industrial innovation, and providing an important guarantee for building a biomedical industry with global influence.
