For a long time, overseas drug and medical device companies have issues over China’s slow registration and approval process. This could result in delaying market launch in China of their products. Recently, CFDA has been addressing these issues by making changes to its procedures, in order to attract innovative drugs and devices to China to meet its domestic needs. In addition, joining of CFDA to ICH was a quantum leap forward leveraging existing international harmonization of the drug approval process for China.
CFDA has also adopted measures to reduce the time to market. In a bid to meet the growing domestic demand for affordable medicines and devices. Recent updates in CFDA regulation towards this direction: removal of the requirement for global multi-center trials to be in Phase II or III clinical trials with prior foreign approval; allow overseas companies to apply directly for market authorization after clinical trials are done. The CFDA also opened a “fast lane” for approval with innovative drugs and devices meeting prioritized domestic market demand.
CFDA’s recent efforts to simplify and streamline regulatory approval process is a promising development. With its success, China shall become an ever important market for overseas pharma and device manufacturers.
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