Literature


Five Signs of CFDA’s Unveiling New Regulatory Measures
DATE: 2015-01-05

The past three years is the prelude symbolizing China’s deep changes in pharmaceutical industry; such reforms will continue in the years to come. Although CFDA has yet to present a framework for thorough changes, drug producers can see the momentum by analyzing the new measures unveiled in the past year.

 

Through long-term focus and careful filing, the author has now sorted out the series of new regulatory measures for drug producers:

 

1、Avoid resource piling-up and unveil new policies on approval and transfer

 

The implementation of 2010-version GMP has exerted a huge impact on Chinese pharmaceutical companies, especially on small and medium-sized ones. If a company has small scale, simple or old product structure, weak profitability and comprehensive management capacity, it should embrace the trend of merger and acquisition actively or passively.