Li Tianquan: Interpretation of drug technology transfer policy and project docking

On November 18, Li Tianquan, the co-founder and senior engineer of yaozhi.com, the "marriage" of the elite club of Yaozhi, China Pharmaceutical University, and the editorial board of pharmaceutical progress will jointly hold the "China (Nanjing) 2015 pharmaceutical information access and utilization forum" in China Pharmaceutical University (Xuanwumen campus) At the meeting, Li Tianquan, the co-founder and senior engineer of yaozhi.com, made an academic report, policy interpretation and project docking of drug technology transfer Let's review the highlights of the lecture: first of all, Li Tianquan briefly analyzed the change trend of drug technology transfer policy Before 2013, the State restricted the transfer of drug technology (including drug technology transfer and new drug technology transfer); from 2013 to 2015, the state encouraged the transfer of drug technology (including non sterile products and sterile products); from 2015 to 2017, the state encouraged the transfer of drug technology, but only non sterile products); after 2017, the State restricted the transfer of drug technology (including drugs Technology transfer, new drug technology transfer) Secondly, Li Tianquan outlined the relevant laws and regulations of drug technology transfer He pointed out that there are three types of drug technology: single drug transfer, production line, approval transfer and drug factory transfer Some cannot be transferred, for example, the relevant legal registration of the transferor or the transferee is invalid; the transfer out is not approved by all the holders of the new drug certificate; the effective approval documents cannot be provided; narcotic drugs: including psychotropic drugs (class I all, class II raw materials), and the varieties of easily made toxic chemicals In the case of non transfer, there are still some flexible strategies For example, the substantial buyout means that the total distribution right is bought out, and the drug approval document is not transferred Or first form a famous group (recognized by industry and Commerce), transfer varieties within the group, and then split after the transfer is successful, and become an independent unrelated enterprise Another way is to set up "workshops outside the factory" to produce the varieties to be transferred Then it is independent as a production enterprise in the form of continuous separation Finally, the transferor withdraws and the varieties to be transferred belong to the transferee Note: according to SFDA registration department's reply on the ownership of varieties after some workshops are independent of drug manufacturers (SFDA [2003] No 56): "after the workshops outside the factory are independent of drug manufacturers, the varieties that were legally produced in the workshop can be supplemented according to the change of the name of drug manufacturers on the premise of clear product ownership Fill in the application for variety transfer formalities " Finally, Li Tianquan also analyzed the current situation of drug technology transfer in detail, pointing out that each provincial Bureau has successively obtained the authorization of "drug technology transfer review" At the meeting, Li Tianquan recommended to you the drug technology transfer platform, yaozhi.com As the largest pharmaceutical technology trading platform in China, yaozhi.com can provide data analysis, matchmaking and trading, and technical support.