Drug Regulatory Scheme: China

FYI – A brief (2-page) news item and analysis appeared in the December 2018 issue of Nature Reviews Drug Discovery (Volume 17, pages 858-859) entitled “Reforming China’s drug regulatory system”. The “Reforming” of the CFDA may have an impact on nonclinical CROs and nonclinical drug development.for US companies that use laboratories in China.
Jack Budny

1 reply
  1. Harri Jarvelainen
    Harri Jarvelainen says:

    The most important thing to know here for toxicologist is that the ICH harmonization may have made dual (FDA & CFDA) compliant IND packages non-essential – one may now start clinical trials in the US and include China to the global program soon after, without a need for the excessive CFDA-compliant preclinical studies. The IND submission timeline is just 60 days. The CMC requirements have also relaxed. Overall, the clinical trials space will probably explode in China, innovative companies will continue to mushroom and low-quality generic manufacturers will disappear.

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