Recently, rumors that China CFDA will shortly unveil the second draft of its pending IF formulation registration rule have been circulating. Industry insiders have revealed the following key potential updates:
The power of implementing the pending registration requirement for both domestic and imported IF formulations would be centralized under the roof of CFDA. AQSIQ won’t be responsible for registration of imported IF products.
Domestic IF companies may only be allowed to have 3 IF brands. It’s still unknown whether this requirement will be applied to imported IF products.
It’s is expected that the final draft would be released before the new year.
The pending regulation is of huge significance to China’s 70 billion RMB IF market and the industry is waiting with bated for the release of the finalized requirements.
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