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The State Food and Drug Administration issued an announcement
Write off rosiglitazone maleate tablets
and 223 drug registration certificates
The deregistration involves multiple businesses
The drugs that cancelled the drug registration certificate are rosiglitazone maleate tablets, hypromellose eye drops, cimetidine tablets, methyltestosterone tablets, compound acetylsalicylic acid tablets, chloramphenicol tablets, azithromycin tablets, pediatric compound sulfamethoxazole tablets, etc., involving a number of enterprises.
Among them, GlaxoSmithKline (Tianjin) Co., Ltd. has cancelled 4, Pfizer Pharmaceutical Co., Ltd. has cancelled 5, Suzhou Yifan Pharmaceutical Co., Ltd. has cancelled 20, Hainan Boda Pharmaceutical Factory has cancelled 18, and Ningxia Qiyuan Sinopharm Co., Ltd. has cancelled 101.
There are more than 5 drug cancellation documents
From the perspective of generic names, among the drugs that were cancelled by the announcement, the number of dextrose injections, oxygen, metamicin tablets, oxytetracycline tablets, tetracycline tablets, furazolidone tablets, and vitamin C injections were all 5 or more.
219 drugs were cancelled upon application
From the perspective of deregistration, except for oxygen held by Ningxia Xingping Fine Chemical Co., Ltd. and anti-rheumatic liquid, rheumatic painkiller liquor and Xueqi medicinal liquor held by Ningxia Rongsheng Pharmaceutical Co., Ltd., the remaining 219 drugs are cancelled according to the application.
Cancellation of the catalogue of drug registration certificates
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Article 83 of the Drug Administration Law of the People's Republic of China stipulates that, after evaluation, the drug registration certificate shall be cancelled for drugs with inaccurate efficacy, large adverse reactions or other reasons that endanger human health.
Drugs that have been deregistered from the drug registration certificate shall not be produced or imported, sold or used.
Drugs that have been cancelled from drug registration certificates, exceeding the validity period, etc., shall be destroyed by the drug regulatory department under supervision or other harmless treatment measures shall be taken in accordance with law.
Source | State Food and Drug Administration, Jiangsu Market Supervision, copyright belongs to the original author
Edit | Runqi
Proofreading | He Qiyun
Review and sign | Shum Jay Chang