Getting rid of "foreign evidence" China's new drugs need to be developed collectively

Dr. Liu Shengjiang, chief scientist at Bayer Pharmaceuticals, said that if it were a new drug developed by China itself, the drug manual would naturally be based on "Chinese evidence", and that many of the drugs currently on the market abroad would be introduced into China. In this regard, the industry is eager for China's new drugs can be "born" as soon as possible.
"China's drug instructions are based on 'foreign evidence', which is because there are few 'new Chinese medicines', " he said. On July 5, the Beijing-California Chinese Biopharmaceutical Entrepreneurs Forum was held in the Beijing Economic and Technological Development Zone, and Dr. Liu Shengjiang, Vice Chairman of the Organizing Committee and Chief Scientist of Bayer Pharmaceuticals, understood that the "foreign guidance" derived from the "foreign evidence" was not enough for the Chinese.
found that the maximum dose guidance for an introduced blood lipid-lowering drug was 10 times higher than the standard rate of muscle damage to Chinese of the drug. Liu Shengjiang said that if China developed its own new drugs, the drug description will naturally be based on "Chinese evidence", and many of the drugs are currently listed abroad for sale, the introduction of China.
this is undoubtedly the "birth" of China's new drug. "New drugs to protect public health are speeding up the review," said Xu Jiaqi, director of the Drug Review Center of the State Food and Drug Administration.
" 2015 China's drug review backlog of 22,000, as of yesterday, the backlog has dropped to less than 5000. "
" A few years ago, our first new drug was approved in 19 months, and now we can get approval in 2 months. "The person in charge of Beijing Tianguangshi Biological Company.
"New drug patents have a protection period, if the completion of the review only three or five years, who will develop new drugs?" Xu Jiaqi said that innovative drug review capacity must be strengthened, because the drug patent protection period from the date of application, the United States, Japan have implemented a patent compensation period system, for this reason, the review reform is also in full international standards. On June 19, China's State Administration of Food and Drug Administration joined ICH as a member, and international innovative drugs will not be signed up in China's evening market, and Chinese enterprises will be able to register internationally simultaneously.
international integration is almost in the "reverse force" evaluation efficiency improvement. "We have perfected the review system, and when phase I clinically, applicants can communicate with the review scientists," Xu said, noting that the goal of the reform is "to protect public health, encourage pharmaceutical innovation, and improve the quality of the industry."
"I am very pleased to have the opportunity to systematically understand the reform of China's drug review, which is in line with the Forum's position as a 'communication platform'," Liu shengjiang said. (Science and Technology Daily)