The China Food and Drug Administration (CFDA) is creating a priority review pathway to cut the time it takes for some drugs to come to market. CFDA is aiming the initiative at products to treat certain significant illnesses and those that use advanced technology to deliver clear therapeutic benefits.

In the proposal, CFDA details the criteria by which it will assess the clinical value of a product and, by extension, its suitability for inclusion in the priority review program. As well as considerations such as the use of advanced technology, the list of criteria includes the seven groups of patients CFDA is trying to serve through the fast-track scheme. Cancer, rare diseases, AIDS, tuberculosis and viral hepatitis are the five diseases being prioritized by CFDA. The other classes of drugs in line to receive priority review are those aimed at pediatric and elderly patients. 

Products that fit into the priority review categories will benefit from shortened regulatory timelines throughout the development and approval processes. CFDA has committed in writing to handling various steps of the processes within a certain timeframe, theoretically giving applicants far greater visibility into how long they will have to wait for a decision. Each of the timeframes is measured in days, with the single longest step taking 90 days. CFDA has given itself as few as five days to carry out certain tasks. 

The regulator is to implement the tightened timeline alongside a more flexible approach to certain aspects of the research and submission process. In rare diseases, for example, CFDA is open to firms running very small trials, an essential allowance given the tiny patient populations associated with some conditions. CFDA will review the requirements for rare disease drugs based on the size of the patient population and level of unmet need in China. The regulator is to take a similarly flexible approach to breakthrough drugs, giving conditional approval to those that are significant advances.

If the priority review process works as envisioned by CFDA, it will free a subset of products from the slow, onerous pathway drugs traditionally follow in China and cut the time it takes for patients to get access to therapies that cater to major unmet needs. Yet, in focusing its attention on products that are in some way exceptional, the scheme falls short of being a fix for the time-consuming, opaque primary process that has attracted the criticism of drugmakers. 

(SOURCE: Regulatory Affairs Professional Society)