In May, 2018, Chinese government published the first rare disease national list, the list contains 121 diseases which published by China National Health Commission in together with other four Chinese government agencies. Although there is not yet a definition of rare disease in China, this first list contains Albinism, Hemophilia, Neonatal Diabetes Mellitus are all…
The second batch of off patent drugs published by China Center for Drug Evaluation (CDE) contains 7 abroad approved drugs, which are regarded as clinically valued and the patent of chemical compounds has been expired, invalid or terminated in China, however, there is still no generic drug application in China until October, 2018. The Anti-HIV…
On Mar 28th, 2019, China CDE announced a new batch of Reference Listed Drugs on its website for public opinion from Mar 28th to April 15th. It’s the 21st batch of RLD list published officially since China initiated the industry-wide generic drug consistency evaluation, and it’s the first time injection RLD being included. Among the…
On March 28th, China Center for Drug Evaluation (CDE) released an “urgently needed” new drugs list for fast track, accelerated approval, priority review which contains a list of 30 overseas country approved new drugs. This list mainly refers to new drugs for the treatment of rare diseases and for the prevention and treatment of diseases that seriously endanger life or seriously affect quality of life, which have been existingly approved by US FDA, the European…
Since March 1st, 2019, China will reduce taxes on rare disease drugs: the importation is taxed at 3% reduced rate, and the domestic production, wholesale and retail can adopt 3% rate according to the simple calculation method. The first tax-reduction rare diseases list includes 21 drug preparations such as Bosentam Tablets, Iloprost solution for inhalation…
Until February 13th, 2019, the China Center of Drug Evaluation, National Medical Products Administration (CDE-NMPA) has announced 126 drugs’ information which passed the consistency evaluation on its website. The public information includes the basic information of drugs and companies, the BE test data and product specifications. According to the third-party statistics, the total number of…
On July 10th, 2018, the China National Medical Products Administration (NMPA) officially issued the Technical Guidelines for Accepting Overseas Clinical Trial Data of Drugs. With the release of this Guidelines, the qualified overseas clinical trial data can be directly used for pharmaceutical registration in China, which makes the simultaneous R&D work of new drugs feasible…
