Guideline speeds access to drugs
Drugs developed in other countries are expected to be available for use on the Chinese mainland more quickly under a new guideline released by the central government. Authorities in China will now accept data collected from clinical trials conducted outside the mainland for applications to register drugs and medical equipment, according to the guideline on reforming approval procedures, which was released by the State Council. The data must be collected from clinical trials conducted at more than one center and must meet Chinese regulations for registration of drugs and medical equipment, the guideline said. Under current regulations, food and drug authorities cannot accept clinical trial data collected from overseas, and new drugs being developed overseas should finish their first phase of clinical trials overseas before developers can apply to start clinical trials on the mainland, according to Wu Zhen, vice-minister of the China Food and Drug Administration. This has delayed the availability of some major drugs on the Chinese market, he says.