"Our registration documents submitted to SFDA almost were withdrawaled", the president of a Chinese pharmaceutical enterprise said."From 2005 to 2006, we totally submitted the registration applications of 9 drugs. But olny one drug was approved by SFDA. The average cost for a drug is 70,000-80,000 Yuan. The applications were rejected in the end, and our effort didn't work out. "
Now it's a normal phenomena that registration documents are withdrawaled by SFDA.
Recently at the International Biotechnological Economy Symposium, the principals coming from dozens pharmaceutical enterprises said in succession, "From last year to now, the speed of examination and approval for registration application is very slow, and it's hard to communicate with the officals of the relevant departments of SFDA. So for enterprises, drug R&D and registration application is almost stagnant and this greatly blocks enterprise's development. "
Wu Zhen, the deputy director general, said the phenomena that pharmaceutical enterprises said is actually existing, but the drugs being rejected by SFDA most are changing formulation drugs or copy drugs. Because SFDA strengthens the examination for changing formulation drugs or copy drugs.