China’s Food and Drug Administration Agency aims to move drugs through the pipeline at a faster pace.
China’s FDA is in a race to the clinic. The country’s approval agency is making an effort to shorten trial approval time and do away with limiting restrictions, in order to get drug candidates to trials within an abbreviated timeline. The agency is trying to make trial sites easier to open, inching away from previous stringent requirements that had been called for site certification.
The initial briefing on trial reform indicates a number of measures meant to make the taxing trial process both speedier and more expansive. The seven steps to improve time to market are thus outlined, with a key change being that researchers no longer need to wait as long for the CFDA to okay a trial. The agency would have 60 days to respond to a request to begin a trial — a lack in response would be accepted as a go ahead. In the U.S. this time frame is 30 days, so while still longer, it is significantly less than previous estimates of 195 days.
Another goal of the reform is to increase the amount of trial sites, which are currently low — especially taking into consideration the country’s size and population. For a site to be given approval to conduct trials, it must be certified, which is a major deterrent for a host of sites. The proposal would cut this blockade out of the equation, allowing sites to register to host trials, and be approved that way. This is likely to increase the amount of trial sites and attract investments especially from foreign companies seeking to conduct early phase trials in the region. Patient data from foreign countries will also be accepted, which is a step for the region towards the shared international requirements for trials, proposed by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), that is already employed in most developed regions.