Public Network poster news reporter Dong Haoqian reported from Jinan
On September 2, the Information Office of the Shandong Provincial Government held a press conference to interpret the "14th Five-Year Plan for Drug Safety in Shandong Province". Cao Sen, director of the Registration Department (Administrative Licensing Department) of the Shandong Provincial Food and Drug Administration, introduced that in the first half of this year, the Shandong Provincial Food and Drug Administration issued 23 measures to promote the high-quality development of the pharmaceutical industry and 30 measures for the development of traditional Chinese medicine, and 65 new products were approved for listing, ranking second in the country, of which 8 were innovative drugs, improved new drugs, and new Chinese medicine drugs, which were twice the total in the past 5 years. The first self-produced vaccine in Shandong Province was approved for marketing, and the "Xuan Lung Septic Granules" settled in Shandong Province.
Cao Sen said that during the "14th Five-Year Plan" period, the Shandong Provincial Food and Drug Administration will adhere to the reform of the drug and medical device review and approval system as an important starting point for promoting the high-quality development of the pharmaceutical industry, optimize the review and approval process, encourage drug innovation and research and development, solidly promote the work of drug registration and licensing, continuously improve the ability to serve the development of the pharmaceutical industry, and consolidate the industrial foundation of drug safety. Focus on actively encouraging the innovation of pharmaceutical equipment in our province, further promoting the consistency evaluation of generic drugs, and further promoting the implementation of the drug holder system and the medical device registrant system to do a good job in the development of the service industry.
In terms of actively encouraging the innovation of shandong pharmaceutical devices, the Shandong Provincial Food and Drug Administration will coordinate and accelerate the review progress. Make good use of the relevant policies of the state to accelerate the listing of drugs, coordinate with the State Food and Drug Administration to include drugs with major innovations that meet clinical urgent needs into the scope of priority review, and give them conditional approval. This year, the two "global new" innovative drugs approved by our province - tetaciloxip for injection and videcilumab for injection - have been approved for listing after completing the Ι and Phase II clinical trials, and enterprises can supplement and improve the Phase III clinical trial data, which has greatly accelerated the product listing process.