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  • China NMPA Registration Questions - China Med Device
    What is China NMPA medical device registration timeline? The timeframe of China NMPA medical device registration can vary from 12 to 22 months The time length is dependent on the product, such as the classification, required testing, etc
  • NMPA (CFDA) Regulations - China Med Device
    NMPA (CFDA) English Regulations China Med Device provide complementary English copy of China NMPA (CFDA) regulations, including: General Decrees, Registration Filing, GMP QMS, Clinical Evaluation, Guideline Standard, PMS, etc
  • New Drug Approvals in China in 2021 - DIA Global Forum
    In June, the NMPA approved the first cell therapy in China, axicabtagene ciloleucel, for the treatment of recurrent or refractory large B-cell lymphoma after previous second-line or more systemic treatment In September 2021, the global new drug and second CAR-T product, relmacabtagene autoleucel injection, was approved
  • 2025 NMPA Approvals: China Clears Record Number of New Drugs
    With the tremendous development of China’s innovative drug industry as backdrop, 2025 saw the number of new drugs approved by the National Medical Products Administration (NMPA)—the country’s regulatory authority—reach triple digits for the first time, an increase that was driven primarily by therapies developed domestically
  • UDI Database - China Med Device
    NMPA launched Unique Device Identification (UDI) Database on its website on August 10, 2020, facilitating the implementation of China UDI system for the first group of devices which will take effect on October 1, 2020
  • Evolving Policies and Use of RWE in Regulatory Decisions in China
    NMPA and CDE continue to encourage use of RWE through their emphasis on data mining of historical real-world data, direction on how to efficiently collect and translate RWD into high-quality RWE suitable for regulatory purposes, and support of pilots and other initiatives that introduce more therapies to Chinese patients
  • NMPA: Four IVD Guidelines Issued - China Med Device
    NMPA published the four IVD-related guidelines on January 18, 2024 They are aimed to facilitate manufacturers with more product-specific guidance and clarity in registration process
  • Appendix: New drugs approved by the NMPA in 2025
    Comprehensive list of new drugs approved by China’s NMPA in 2025, including chemical and biologic therapies, targets, disease indications, and approval dates
  • NMPA Medical Devices regulation - China Med Device
    The NMPA issued the “Regulation on the Supervision and Administration of Medical Devices” on January 7, 2025, a revised version of the same-named regulation implemented on June 1, 2021
  • China Focusing Innovation Through ICH Global Regulatory Vision
    NMPA has aligned itself with the ICH guidelines through three principles The first is to ensure that its own content does not conflict with the ICH guidelines The second is to fully draw on the guidelines of developed regulatory agencies in Europe (EMA), the US (FDA), and Japan (PMDA) to ensure that China aligns with international standards





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