China National Drug Agency (CNDA) has released guidance aimed at manufacturers of drugs it wants to make available in the country. The guide builds on the earlier publication of a list of 48 drugs that China is willing to approve on the basis of limited data.
In the summer, CNDA identified clinically important drugs that are available in other markets but are yet to win approval in China. To encourage the manufacturers of these drugs to bring them to China, CNDA offered to issue marketing authorizations on the strength of data showing how they perform in people of different races and ethnicities. The proposal offered a radically reduced path to market but lacked details about exactly what is expected of applicants.
Now, CNDA has shared a document detailing the requirements applicants must meet to bring drugs to market under the truncated pathway. The text addresses some of the key questions raised by the fast-track proposal, such as what data on racial and ethnic differences CNDA wants to see before approving a product.