According to new Drug Registration Regulation recently published, the insiders said, "the technology threshold rises greatly for copy drugs and changing formulation drugs with low technology. Previous way of drug registration "short time, easy to get approval" is no longer existing."
Now for copy drugs or changing formulation drugs, the time limit of examation and approval is prolonged to 160 working days from previous 80 working days, namely adding 4 months. Adding up the time spending on pre-registration research and middle test etc., it should take about 3 years to get the production approval from SFDA for a oral solid copy drug. At the same time, the cost of registration is higher, and the risk of rejection by SFDA also increases. All these should cause the registration amount of copy drugs and changing formulation drugs reduces greatly, and the rate of drugs getting the approval should also reduce.
It can be affirmed that the research & development way of copy drugs or changing formulation drugs should become no longer easy. The amount of drug registration just for meeting the marketing needs should reduce to a great extent.