How medicines and medical devices get approved in China

The standard route for a new drug that is not marketed anywhere. The applicant gets clinical trial approval, runs the trials, and then files a marketing application. The Center for Drug Evaluation reviews it within a limit of 200 working days, and the agency issues a drug registration certificate valid for 5 years.

Full application, new active substance · target 200 days · verified October 3, 2026

A route for drugs that improve a known active substance, for example a new salt, dosage form, route, combination or indication, and that show a clear clinical advantage. The procedure and time limits are the same as for innovative drugs.

Full or mixed application, known active substance · target 200 days · verified October 3, 2026

During clinical trials, an innovative or improved new drug for a serious or life-threatening disease can enter the breakthrough therapy procedure if there is no effective treatment or it shows a clear advantage. It gives more meetings with the Center for Drug Evaluation and advice on staged data. Products in it can later ask for priority review.

Intensive development support designation · verified October 3, 2026

A drug can be approved on early clinical data that show efficacy and predict clinical value when it treats a life-threatening disease without effective treatment or meets an urgent public health need. Some urgently needed vaccines also qualify. The certificate lists its validity and the studies to finish after approval.

Conditional or accelerated approval · verified October 3, 2026

Drugs with clear clinical value can get priority review at the marketing application. The review limit is 130 working days instead of 200, and 70 working days for urgently needed rare disease drugs already marketed abroad but not in China. Inspection, testing and name approval are scheduled first.

Priority or accelerated review · target 130 days · verified October 3, 2026

When a public health emergency threatens or happens, the agency can use special approval for drugs needed to respond. Acceptance, review, inspection and testing run faster and in parallel. Use can be limited to a set period and scope. Separately, vaccines can be used in an emergency within a set scope and period after expert review.

Emergency or temporary authorisation · verified October 3, 2026

Since September 2025, qualifying clinical trial applications for category 1 innovative drugs can be reviewed within 30 working days of acceptance, instead of the general 60 day implied approval. Applicants must prepare the lead trial site and ethics review in parallel and start the trial within 12 weeks of approval.

Other route · target 30 days · verified October 3, 2026

Designated hospitals in the Boao Lecheng pilot zone in Hainan can import drugs and devices approved abroad but not registered in China, when clinically urgent. Hainan health and drug authorities approve each use. Real-world data from this use can support a later registration in China.

Early or compassionate access · verified October 3, 2026

Designated hospitals in nine mainland cities of the Greater Bay Area can import urgently needed drugs already marketed in Hong Kong or Macao, and urgently needed advanced devices used by Hong Kong or Macao public hospitals. Products on the catalogue get decisions in about 5 plus 5 working days, others in about 10 plus 10 working days.

Early or compassionate access · target 5 days · relies on HK, MO · verified October 3, 2026

A hospital with an urgent clinical need can import a small quantity of an unregistered drug, or of a class II or III device, with approval from the national agency or a province authorized by the State Council. The product is used only in the named hospital for a specific purpose.

Early or compassionate access · verified October 3, 2026

A drug or device in a clinical trial for a life-threatening disease without effective treatment can be given to other patients with the same condition at the trial site, after ethics review and informed consent, when medical observation suggests benefit. Devices and diagnostics are given free of charge, and their safety data can support registration.

Early or compassionate access · verified October 3, 2026

A route for generic chemical drugs that copy an originator product. The generic must match the reference product in quality and efficacy, usually shown by a bioequivalence study that is filed rather than approved. Generics may go straight to a marketing application when clinical trials are not needed.

Generic application · target 200 days · relies on EU, JP, US · verified October 3, 2026

China classifies drugs as prescription or nonprescription. Some products can file directly as nonprescription drugs, for example when the same active ingredient, indication, dosage form and strength is already sold as an OTC drug. After technical review, a separate suitability review for OTC use is done within 30 working days.

Non-prescription application · target 200 days · verified October 3, 2026

Vaccines follow the drug registration procedure with extra rules from the Vaccine Administration Law. Trials run only at qualified top-level hospitals or provincial disease control centers. After approval, every batch needs lot release before sale or import.

Full application, new active substance · target 200 days · verified October 3, 2026

A drug-device combination product is made as one unit. It is registered as a drug if the drug action is primary, or as a device if the device action is primary. When the primary mode is unclear, the applicant asks the national device standards center to decide first. The lead review center can share the file with the other center for joint review.

Other route · verified October 3, 2026

Class I devices and diagnostic reagents are filed, not registered. Makers in China file with the city-level drug authority. Overseas makers file with the national agency through a company in China. Filing is complete when compliant documents are submitted, and the information is published within 5 working days.

Device: premarket notification · verified October 3, 2026

Class II devices and diagnostic reagents are medium risk. Provincial drug authorities register domestic products, and the national agency registers imported ones. The technical review limit is 60 working days, followed by a decision within 20 working days. The certificate is valid for 5 years.

Device: registration or licence with the regulator · target 60 days · verified October 3, 2026

Class III devices and diagnostic reagents are the highest risk group. The national agency registers both domestic and imported products. The technical review limit is 90 working days, followed by a decision within 20 working days. The certificate is valid for 5 years.

Device: registration or licence with the regulator · target 90 days · verified October 3, 2026

Devices with a core Chinese invention patent, a near-final design and a working principle that is first in China, with fundamental improvement and clear clinical value, can enter the innovative product procedure. The agency assigns contacts and offers meetings before and during review. Small and micro companies pay no fee for the first registration.

Device: breakthrough or priority program · verified October 3, 2026

Devices for rare diseases or cancer with a clear clinical advantage, devices for diseases of older people without effective options, devices made for children, urgently needed devices with no similar registered product, and devices from national key research programs can ask for priority registration. Review and quality system inspection are scheduled first.

Priority or accelerated review · verified October 3, 2026

For a public health emergency, the agency can use emergency registration for devices with no similar product in China, or when supply is not enough. Testing, quality system inspection and technical review run in parallel. Devices can also be used in an emergency within a set scope and period after expert review.

Emergency or temporary authorisation · verified October 3, 2026