2012 China Drug Review Annual Report药品审评中心发布英文版《2012年度中国药品审评报告》.pdf

2012 China Drug Review Annual Report Center for Drug Evaluation (CDE), China Food and Drug Administration (CFDA) Date of release: February 28, 2013 On August 31, 2012, a 60 cm high bronze statue called the sick child was unveiled in Stolberg, West Germany. On the left of the bronze statue is a girl born without arms and with defected legs leaning in a chair and the right side is an empty chair. In the middle of the foundation, the following words are carved: “In memory of the dead and survived thalidomide victims”. This year marks the 50th anniversary of thalidomide incident. It is this tragedy that once shocked the world. In the 1950s, a German drug manufacturer introduced the sedative of thalidomide, which became popular in many countries for its effectiveness in alleviating the symptoms of morning sickness during early stages of women’s pregnancy. Meanwhile, a medical officer, named Frances Oldham Kelsey at the US Food and Drug Administration (FDA) was reviewing information submitted by this German company. Because of her concern over the data, thalidomide’s approval was withheld in the United States. Later, when congenital missing limbs of newborn infants, i.e. thalidomide babies emerged from Europe, Australia, Canada and Japan where the drug was used, it became clear that, with the support of scientific evidence, the culprit of missing limbs in newborn infants is thalidomide. By then, there were almost 10,000 thalidomide babies born around the world. It is also this tragedy that has driven the reform effort in improving scientific review and approval system in various countries of Europe and the US since the 1960s. China’s escape from the tragedy is mainly due to relatively underdeveloped innovated drug sector and lack of the connectivity of pharmaceutical industry to the rest of the world. However, China had its own challenges, mainly a serious shortage of drugs as most of drug research and develop