title: Guidelines and strategy of the International Conference of Harmonization (ICH) and its member states to overcome existing impurity control problems for antibiotics in China.
abstract: In the present report, we review the technical guidelines and principles on impurity research and control for antibiotics established by various agencies, including the International Conference of Harmonization (ICH), the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the China Food and Drug Administration (CFDA). Progresses with the US Pharmacopoeia (USP), the European Pharmacopoeia (EP) and the Chinese Pharmacopoeia (ChP) to control impurities in antibiotics are also presented. Next, our discussion is focused on analyzing the CFDA's requirements on impurity research and control for antibiotics, and the implementation of ICH, FDA and other technical guidelines for generic drugs impurity control in China. Existing problems are further reviewed, in order to improve the overall process for the control of antibiotic purity.
authors.affiliation: Key Laboratory of Drug Targeting and Drug Delivery System, Ministry of Education, West China School of Pharmacy, Sichuan University, Chengdu 610041, China; Center for Drug Evaluation, China Food and Drug Administration, Beijing 100038, China.
authors.forename: Yu
authors.initials: Y
authors.lastname: Jiang
authors.affiliation: China Pharmaceutical University, Nanjing 210009, China.
authors.forename: Jun-Ping
authors.initials: JP
authors.lastname: Xia
authors.affiliation: Center for Drug Evaluation, China Food and Drug Administration, Beijing 100038, China.
authors.forename: Jian-Hong
authors.initials: JH
authors.lastname: Yang
authors.affiliation: Center for Drug Evaluation, China Food and Drug Administration, Beijing 100038, China.
authors.forename: Zhe-Feng
authors.initials: ZF
authors.lastname: Zhang
authors.affiliation: China National Institutes for Food and Drug Control, Beijing 100035, China.
authors.forename: Chang-Qin
authors.initials: CQ
authors.lastname: Hu
authors.affiliation: Key Laboratory of Drug Targeting and Drug Delivery System, Ministry of Education, West China School of Pharmacy, Sichuan University, Chengdu 610041, China. Electronic address: zrzzl@vip.sina.com.
authors.forename: Zhi-Rong
authors.initials: ZR
authors.lastname: Zhang
mesh_terms: D000900:Anti-Bacterial Agents / Q000592:standards*; D002681:China; D004340:Drug Contamination; D004335:Drug and Narcotic Control; D016568:Drugs, Generic; D005060:Europe; D006801:Humans; D004364:Pharmaceutical Preparations / Q000592:standards*; D010602:Pharmacopoeias as Topic; D011786:Quality Control; D012106:Research; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000900:Anti-Bacterial Agents; D016568:Drugs, Generic; D004364:Pharmaceutical Preparations
keywords: Antibiotics; Bridging; China; Guidelines; Impurity control