China Expediting the Review and Approval of Drugs to Treat Life Threatening Diseases
Chinese health authority published a list with 48 orphan drugs that qualify for an expedite review process of their registration application. The 48 drugs are used for the treatment or prevention of rare and life-threatening diseases, and have already been approved outside of China in one of the reference countries such Japan, the United States, or Europe.
According to this new regulation, the China National Drug Administration (CNDA) will waive the requirement for local clinical trials. To qualify for the expedite review process, manufacturers of the critically needed drugs will need to show that their products have already been approved by health authorities in Japan, the United States, or Europe,. They also need to submit data to demonstrate that no racial or ethnic differences between the populations will affect the product’s efficacy.