The Centre for Drug Evaluation (“CDE”) of the CNDA released the List of Overseas Drugs in Urgent Need (“List”) on 8 August 2018. The List was open for public opinions before 18 August 2018.
The List covers 48 kinds of drugs (names mentioned below) which have been approved to market in the United States, EU or Japan and regarded as urgently-needed drugs by CDE. CNDA will give priority review to the marketing application of these drugs. The applicant can directly file the marketing application without conducting clinical trials in China.
Following the market application, further documentation would be required for the priority examination, including but not limited to:
- marketing certificates of the relevant drug issued by the drug authorities in US, EU or Japan;
- a report of racial sensitivity analysis;
- a post-marketing research plan and a post-marketing plan on risk control; and
- a statement that the application materials submitted in China are the same with the materials submitted to the overseas authority, including the post-market research materials.
Application materials should be prepared in the format of the Common Technical Document (“CTD”) of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ("ICH")
To read the full text of the List, please click here.