Tuesday Drugs developed overseas to be available
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.
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.
“The purpose of the measure is to reduce the time needed for approval of drugs from overseas,” Wu Zhen, vice-minister of the China Food and Drug Administration, said on Monday.
China’s current drug evaluation and approval system needs improving to expedite the use of new drugs in China, Wu said.