China Ministry Reshuffles to Create New Drug Regulator

In March 2018, China’s National People’s Congress approved plans for the China Food and Drug Administration (CFDA) to be merged into a newly formed National Market Supervision Administration, part of an overhaul of ministries. A new State Drug Administration under the merged ministry will be responsible for overseeing drug approvals. The plan, which still lacks key details, is aimed at reducing overlap between agencies and clarifying responsibilities for the food and drug industries. The new drug agency will have authority down to the provincial level, leaving post-approval marketing and sales monitoring to city and county authorities.

Day-to-day drug administration is expected to continue with little disruption. While the move creates some uncertainty for companies, it could enhance regulators’ ability to implement reforms aimed at raising China’s drug regulations to international standards. The government also plans to set up a new bureau to consolidate the administration of national health insurance and social security funds. This bureau will be responsible for drug and health service pricing and negotiating their inclusion on the National Reimbursement Drug List – a key step to achieving a wider patient reach.