Chinese FDA's crackdown on poor-quality drugs shows no signs of easing up
- The Chinese Food and Drug Administration (CFDA) has embarked on a series of reforms to improve quality standards of local drugs. In addition to rejecting dozens of drug applications this year, the agency has asked manufacturers to investigate their own trial data.
- Earlier this month, 82 drug companies voluntarily withdrew their submissions due to quality concerns.
- According to the CFDA, progress in terms of adhering to quality standards varies on a region-by-region basis. China's drug market is the second largest after the U.S.
The CFDA has been increasing regulatory pressure aggressively this year in an attempt to markedly improve quality standards. The domestic market has grown rapidly with roughly $63 billion in drug sales anticipated this year. Global companies like AstraZeneca have also increased investment.
The top 10 drug makers in China have had sales growth of 12% this year, which is roughly double foreign firms, accorindg to IMS consulting.
At the same time, China is attempting to rein in healthcare costs, which are expected to hit $1.3 trillion by 2020.
With Chinese firms growing strongly and the CFDA pushing for better quality, international firms could see greater competition in the Chinese market.