From the second half of 2018, China CDE (Center for Drug Evaluation) has significantly speeded up its review and approval process of imported drug, which can be considered as the result of the national faster imported drug approval policy. According to the statistics of the first quarter of 2019, the number of acceptances and the…
On 20th of April 2019, the 10th Standing Committee meeting of the Thirteenth National People’s Congress in China (“NPC“) was held in Beijing, the draft amendment to the Drug Administration Law (“Amendment DAL”) was submitted for a second review, and below key amendments are announced and discussed: Strengthen the regulation of internet drug sales: Any…
After the “Adjustment Working Scheme of China Health Insurance Drug List in 2019” been published by China National Healthcare Security Administration on 17th April, the new Health Insurance Drug List adjustment in China was officially initiated. According to the Working Scheme the whole process can be divided into 5 main stages: phase 1-preparation period (Jan…
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…
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…
