Tag: china

The port filing, the customs clearance form and the testing that apply to a drug imported into China, with the periods for registration testing.

Breakthrough therapy, conditional approval, priority review and special approval for drugs in China, and which of them shortens a review period.

The national bodies that regulate drugs, devices, reimbursement, genetic resources and personal data in China, and what provinces handle.

How a drug clinical trial is cleared in China, from the 60-working-day rule and the 30-working-day channel to the filings that replace approval.

The national fees for registering a drug or medical device in China, when they fall due, and the exemption for small and micro enterprises.

The number of drug and medical device applications China's national regulator accepted and approved in 2025, and what each count measures.

Which medical device trials in China need approval from the national regulator, which need only a filing, and what each route requires.

The statutory clocks for a security assessment, a standard contract filing and certification of data exports from China, and what extends each.

What China's commercial health insurance innovative drug list is, which drugs may apply to it, and what a place on the list gives.