CFDA becomes the "defendant" again because it does not approve the clinical trial

Guangzhou bercello Pharmaceutical Co., Ltd., a pharmaceutical company that filed a lawsuit with the State Food and Drug Administration for failing to obtain approval for clinical trials of new drugs, recently sued the State Food and drug administration The reason is that the State Food and drug administration does not approve the company's "clinical trial" application for cinnarizine lipid microspheres injection Two years ago, the company also sued the State Food and Drug Administration for clinical trials Berserro told reporters that in 2009, the company applied to the General Administration of food and drug for clinical trials of cinnarizine lipid microspheres injection It was not until August 20, 2011 that the State Food and Drug Administration issued the notice of examination and approval opinions, stating that "at present, there is no reliable information about the approval of marketing and safety and effectiveness of cinnarizine injection This product should be changed from oral preparation to lipid microsphere injection, and comprehensive pharmacodynamics, pharmacokinetics and toxicology studies should be carried out compared with oral preparation" On this basis, the State Food and drug administration did not approve it " Decision of clinical trial On November 18, 2011, berserro filed an administrative lawsuit to the first intermediate people's Court of Beijing On June 26, 2012, the first intermediate people's Court of Beijing rejected percello's claim Besero refused to accept the judgment and appealed to the Beijing Higher People's court The case was sent back to the first intermediate people's Court of Beijing for retrial On January 18, 2013, the first intermediate people's Court of Beijing rejected besero's claim once again Besero appealed to Beijing Higher People's court against the aforesaid judgment On November 25, 2013, the Beijing Higher People's court rejected the appeal and upheld the first instance judgment According to berserro, the notice of approval opinions issued by the General Administration of food and drug has no "technical review opinions", that is to say, without the professional review of pharmacy, it is impossible to confirm whether the quality of the applied drugs is controllable For this reason, berserro is ready to fight with the General Administration of food and drug to the end, and hereby applies to the Beijing High Court for retrial, and requests the Beijing high court to revoke the notice of approval opinions made by the General Administration of food and drug according to law, which has been accepted by the Beijing high court It is reported that in 2012, becero was suddenly stopped by the General Administration of food and drug for the clinical trial of compound reserpine and triamterene capsule which has been carried out for nearly three years, and the latter was sued to the court The first intermediate people's Court of Beijing ruled that the "suspension order" issued by the General Administration of food and drug should be revoked News extension: application for clinical trial registration is dead, Vietnam pharmaceutical company files a lawsuit against CFDA