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英文字典中文字典相关资料:


  • Regulatory timelines in the Asia-Pacific - pharmaphorum
    The TGA does not review any data relating to the clinical trial The institution or organisation where the trial will be conducted – the 'approving authority' – gives the
  • Clinical Research Regulation For Australia and China | ClinRegs
    In accordance with the G-CTHandbook, the G-TrialsSOP, and AUS-47, the Therapeutic Goods Administration (TGA) allows for the supply of unapproved therapeutic goods to be used in clinical trials under two (2) regulatory schemes—the Clinical Trial Notification (CTN) scheme and the Clinical Trial Approval (CTA) scheme
  • Understanding Country-Specific Regulatory Requirements for Clinical . . .
    Clinical Trial Approval (CTA) Scheme: This scheme involves a formal evaluation process by the TGA The sponsor submits an application seeking approval to supply 'unapproved' therapeutic goods in a clinical trial The TGA evaluates summary information about the product, including relevant scientific data, before the start of the trial
  • Technical Guidelines for Accepting Data from Overseas Clinical Trials . . .
    a complete The clinical trial data package can only be used for drug registration applications in China The data submitted for overseas clinical trial data for Chinese drug registration application should include biopharmaceuticals, clinical pharmacology, efficacy and safety data
  • Australian clinical trial handbook - Therapeutic Goods Administration (TGA)
    Clinical trials that do not involve the use of 'unapproved' therapeutic goods are not subject to the requirements of the CTN and CTA schemes This guidance has been developed by the Therapeutic Goods Administration (TGA) and therefore the use of ‘we’ and ‘us’ throughout refers to TGA
  • Regulatory news - apps. who. int
    health products The resources for clinical trials in China will be strengthened, and there will be provisions for acceptance of clinical trial data generated in other countries Reforms will be introduced to speed up the review and approval for urgently needed health products to meet public health needs Furthermore, measures
  • Therapeutic Goods Administration (TGA) Archives - Global Regulatory . . .
    On March 14, 2022, China’s CDE released the “technical guidelines for clinical trials of new chemical enhanced drugs TGA has decided to reform their medical device classification due to safety issues identified and to further harmonize to the European Union
  • Global View of Regulatory Agencies and Drug Approvals
    Median drug approval time as compared to the FDA: According to the latest CIRS report, TGA approved 27 new active substances (NASs) in 2020 The median approval time was 315 days, which is 71 days longer than the median approval time of the US FDA
  • Junshi Biosciences Toripalimab Gains TGA Approval for Nasopharyngeal . . .
    China-based Shanghai Junshi Biosciences Co , Ltd (HKG: 1877, SHA: 688180) has announced receiving marketing approval from the Therapeutic Goods Administration (TGA) of the Australian Government Department of Health and Aged Care for its toripalimab
  • International agreements and arrangements for GMP clearance
    The TGA has various international agreements and arrangements with other countries and regulatory authorities Some of these allow us to rely on each other’s Good Manufacturing Practice (GMP) inspection programs





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