Now there is version 2.0 again, which is the first "whitelist" system for biopharmaceutical research and development products in the country
The reporter learned from the Shanghai Municipal Commission of Commerce that recently, the revised and improved "Shanghai Biopharmaceutical Research and Development Import Pilot Plan" version 2.0 has been officially implemented. The plan, jointly formulated by the Shanghai Municipal Commission of Commerce, Shanghai Customs, Shanghai Drug Administration, Shanghai Science and Technology Commission, and Shanghai Science and Technology Foundation, responds to the specific demands of biopharmaceutical enterprises, shortens the identification cycle of the "white list" of imported biopharmaceutical research and development items, and adjusts it from once every half year to once every month, making the identification cycle of the "white list" more in line with the cycle of enterprises undertaking research and development projects.
In the process of developing new drugs, some imported items will be used as reference materials for drug development, in order to complete preclinical experiments and research projects related to drugs. Among these imported goods, some of them are not listed domestically or internationally, but they are also subject to the supervision of the Import Drug Clearance Form when imported. Due to the fact that these items are not marketed drugs both domestically and internationally, but are only used as research and development items during the drug development process, it is currently not possible to apply for the Import Drug Clearance Form for such research and development items. If enterprises are unable to obtain these imported research and development items in a timely manner, corresponding drug research and development projects may be affected.
In June 2021, the Shanghai Municipal Commission of Commerce, together with the Shanghai Customs, the Shanghai Drug Administration, the Shanghai Science and Technology Commission, and the Shanghai Science and Technology Foundation, jointly formulated the "Pilot Plan for the Import of Biomedical Research and Development Articles in Shanghai", establishing a collaborative mechanism at the city and district levels for the "white list" of imported research and development articles by biopharmaceutical enterprises. For enterprises included in the "white list" of imported raw materials, synthetic precursors, and other research and development articles, they are exempt from processing the "Import Drug Clearance Form", and the pilot period is 2 years.
This policy is the first to be piloted in the Pudong New Area and Lingang New Area. Based on the summary of pilot experience, it will be promoted throughout the city in 2022. As of now, Shanghai has released three batches of imported biopharmaceutical research and development items as a "white list".
The "whitelist" system for biopharmaceutical research and development items in Shanghai was pioneered nationwide. Since then, many regions across the country, such as Beijing, Tianjin, Chongqing, Hubei, Guangzhou, and Suzhou Free Trade Zone, have also drawn on Shanghai's experience to support local innovation in new drug research and development, and have formulated local "whitelist" systems for the import of biopharmaceutical research and development items.
It is reported that the revised and improved version 2.0 of the Shanghai Biopharmaceutical Research and Development Import Pilot Plan has also added a rapid identification mechanism. For enterprises that have been included in the "whitelist", they need to apply for rapid identification of imported research and development items again. Enterprises do not need to submit other application materials except for information on imported research and development items. The municipal joint promotion mechanism will carry out identification in real time.
At the same time, further clarify the requirements for in-process and post event supervision, requiring each district to report on a quarterly basis to the municipal joint promotion mechanism the actual use, subsequent disposal, laboratory management, and other related inspections of imported research and development items of enterprises that have been included in the "whitelist".
The person in charge of the Shanghai Municipal Commission of Commerce stated that the next step will continue to amplify the policy effect, optimize the business environment, and include more eligible biopharmaceutical enterprises in the pilot program.