China established a new drug regulator

After about five years as a standalone agency, the China Food and Drug Administration (CFDA) will merge into a gigantic national market supervision administration, with drug regulation as a new, second-tier bureau underneath.

The Chinese government – known as the State Council – proposed to combine the CFDA with agencies that regulate business registration, quality control, pricing and anti-monopoly efforts into a new department. Operations of the new drug regulator will only extend to the provincial level, while drug sales and marketing activities will be monitored by local market-supervision agencies.

Criticism of poor interagency coordination has been circulating in China, as at least four government bodies have as yet unclear responsibility for regulating the food and drug industry. That fragmentation is especially keen when it comes to marketed products.

The announcement lacks detailed plans for now, but it appears the specialized drug bureau will only focus on drug approvals and related accreditations, leaving post-marketing oversight to the bigger agency it will now belong to.

The government will also set up a new bureau focused on health insurance. It will make national health insurance policies and manage social security funds. More importantly for drug companies, the new bureau will handle drug and health service pricing and negotiate for their inclusion on the National Reimbursement Drug List, which is seen as almost a guarantee of wider patient reach in China.