CNDA Clinical Research Center

CNDA Announcement: 48 ‘Urgently Needed’ Drugs to Receive Fast Track to China Market

cscimmeditor Industry News

On 8th August, 2018 (20180808 – a great number in Chinese), the CNDA (CDE) provided a list of 48 New Drugs that are “urgently needed in China” and that are “already marketed overseas.” These drugs will be offered an expedited evaluation process in accordance with the priority review procedure in a conscious effort to get them to market as soon as possible.

Click here to see the original announcement or contact Richard Tadd for a copy of my translation

The list focuses on new drugs for the treatment of rare diseases approved by the United States, the European Union or Japan in recent years that are not yet available in China, as well as new drugs for the prevention and treatment of diseases that seriously threaten life or seriously affect quality of life, and that currently have no effective method of treatment.

The announcement also provides potential beneficieries with clear instructions on how to proceed.

Great news for the lucky few, amazing news for the Chinese people, and a ray of hope for the future.