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    China New Drug Applications 2004–14: Regulatory Considerations for Clinical Development Supporting Their Approval

    Local clinical data are essential as supporting evidence for new drug applications (NDAs) in China. This article reviews the clinical development process of 148 new chemical entities (NCEs) and new therapeutic biological products approved in China from 2004 through mid-2014. It provides insights into critical regulatory considerations influencing the number of clinical trial patients and choice of development pathway needed to gain regulatory approval in China. Ch...
  • China: New Labeling Requirements for Imported Devices

    Chinese authorities have announced that as of 1 April 2013, all text appearing on the outside labeling and packaging of imported medical devices must be in Chinese, according to a notice issued to provinces, autonomous regions and municipalities by China's State Food and Drug Administration (SFDA) on 24 September. The Chinese text version can be "attached" to the foreign language, though it is unclear what forms will be permitted. Any devices not in compliance with the r...
  • China: Deadlines Established For Opthalmic GMP Implementation

    The Chinese State Food and Drug Administration (SFDA) issued a notice on 25 April to Chinese Provinces and Municipalities regarding the deadlines for implementing the revised Good Manufacturing Practices (GMPs) for ophthalmic solutions. The circular pointed out that the implementation of revised GMPs for sterile pharmaceuticals and sterile bulk drugs is effective as of 31 December 2013. These sterile bulk drugs include ophthalmic preparations, such as those for intra...
  • FDA In Process of Translating Many Publications, Guidances

    The US Food and Drug Administration's (FDA) Associate Commissioner for International Programs, Mary Lou Valdez, said in a statement the agency is working to translate many publications into different languages in order to help its foreign regulatory counterparts. In FDA's 11 April statement, Valdez notes the Office of International Programs (OIP) is "committed to supporting the agency's efforts to become a regulatory agency with a truly global reach." As a result, OIP i...