In the year of 2019, CDE has accepted 6,106 application acceptance numbers of chemical drugs, 413 application acceptance numbers of traditional Chinese medicines and 1,078 application acceptance numbers of biological products (the data is calculated by acceptance number dimension, except for APIs, and the same below). The marketing application acceptance number of chemical drugs is…
On December 1st, 2019, the new edition of “China Drug Administration Law” was implemented officially. This is the second major revision of the law since it was promulgated in 1984. The new law has made corresponding adjustment to the import and export regulations, which promotes the continuous improvement of China’s drug import and export supervision…
Takehomes: The newly revised “Drug Administration Law” encourages drug development and innovation in five major areas, and gives priority to reviewing and approving these medicines. A risk control mechanism for halting clinical trials at any time has been established. The Law introduces an extended clinical trial clause for the drugs used for seriously life-threatening disease.…
Roxadustat approved in China for the treatment of anaemia in non-dialysis-dependent patients with chronic kidney disease China is the first country to approve roxadustat for all chronic kidney disease patients with anaemia AstraZeneca today announced that its partner FibroGen (China) Medical Technology Development Co., Ltd. (FibroGen China) has received marketing authorisation for roxadustat in China…
After communicating with Beijing and Hangzhou Customs for clarification, we have summarised the key takeaways below: Key Takeaways: On April 22, Customs announced the cancellation of label filling for imported pre-packaged foods, meaning from 1st Oct 2019, importers and customs brokers will no longer have to submit to China customs product labelling documentation (inclu. Chinese…
