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China issue new document to accelerate the clinical trial of new drug

  • 1.  China issue new document to accelerate the clinical trial of new drug

    Posted 27 days ago

    On 17th April, Beijing Municipal Medical Insurance Bureau issued The measures to support the high-quality development of innovative medicine of 2024, which states some measures to encourage the drug clinical trial in Beijing.

    Encouraging the drug IND submission and the ethical review at same time. Currently in China, most of the ethics committee in hospitals will approve the clinical trial just after the CDE approval. But now, the ethical review was encouraged to conducting at same time with the IND submission as to accelerate the kick off of the clinical trial.

    Expand the membership of the Mutual Recognition Alliance of the MCT(multi-center clinical study), encourage the mutual recognition of the ethical review in different hospitals. 

    Beijing will as the pilot city to compress the review timeline of IND from 60 days to 30 days, and compress the supplement review timeline from 200 days to 60 days.



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    Jennie Yang
    RA Director
    Heaslicen Pharma Consulting
    www.heaslicen.com
    HeaslicenPharma@163.com
    Beijing, China
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