How a drug clinical trial is approved in China

A drug clinical trial in China requires the approval of the national drug regulator, and the application is treated as approved where the regulator gives no notice within 60 working days of accepting it.¹ The Center for Drug Evaluation carries out the review and notifies the result through its website.² A channel of 30 working days has applied to qualifying innovative drugs since September 2025.³

A reader who knows the 30-day rule for an investigational new drug application at FDA will recognise the mechanism. The Chinese period is 60 working days, and the time an applicant takes to supply further material is left out of the count.² A planned start date that adds 60 working days to the date of acceptance therefore holds only where the reviewer asks for nothing.

The rule in the statute

Article 19 of the Drug Administration Law requires a sponsor to submit truthful data, materials and samples on the development method, the quality indicators and the results of pharmacology and toxicology studies.¹ The drug regulator of the State Council decides within 60 working days of accepting the application and notifies the sponsor. Where no notice is given within that period, the application is treated as approved.¹

Two further conditions sit beside the approval. Article 20 requires the trial to follow ethical principles, to have a protocol and to be reviewed and approved by an ethics committee.¹ Article 21 requires the sponsor to explain the purpose and risks of the trial truthfully to the subject or the subject’s guardian and to obtain a voluntarily signed informed consent form.¹

How the clock runs

Article 23 of the Drug Registration Measures gives the review to the Center for Drug Evaluation. The Center decides within 60 days of acceptance and notifies the applicant through its website. Where it gives no notice in time, the applicant may run the trial under the protocol it submitted.² Article 125 counts every period in the Measures in working days.²

Article 103 lists the time that is left out of the count.²

• time the applicant takes to supplement its materials, to make corrections after an inspection, or to verify the production process, quality standard and label as required
• delay caused by the applicant in an inspection, a test or an expert consultation meeting
• a period in which the review is suspended under a law or regulation
• the time taken by an inspection outside China

Article 102 allows a period to be extended where the nature of the product or the work of review, inspection or testing makes it necessary. The extension may be no more than half the original period, and the technical body that extends it tells the applicant in writing.²

The 30-working-day channel

Announcement No. 86 of 2025 of the National Medical Products Administration is dated 9 September 2025 and took effect on publication.³ It provides for review and approval within 30 working days of acceptance for qualifying clinical trial applications for innovative drugs.³ The application must be for a class 1 innovative drug, which may be a traditional Chinese medicine, a chemical drug or a biological product. It must also meet one of three conditions.³

• The product is a key innovative drug of clear clinical value that is supported under the national policy system for the full chain of innovative drug development.
• The product is a paediatric innovative drug, a rare disease innovative drug or an innovative traditional Chinese medicine that the Center for Drug Evaluation has published as qualifying.
• The product is developed simultaneously worldwide. This covers phase I and phase II trials, and phase III international multi-centre trials led or jointly led by a principal investigator at a Chinese trial institution.

The channel places duties on the applicant before filing. The applicant works with the lead trial institution and runs project initiation and ethics review in parallel with the application.³ The applicant must be able to assess and manage development risk, and must undertake to start the trial within 12 weeks of approval.³

The applicant marks the application form for the channel. The Center decides on acceptance within 5 working days.³ Where a difficult question requires technical consultation or an expert meeting, the Center tells the applicant within 20 working days of acceptance and the 60-day period applies to the application as a whole.³

Filings that take the place of approval

Several steps in development proceed without a fresh approval.

A bioequivalence study is filed on the website of the Center for Drug Evaluation, and the applicant then runs the study under the filed protocol.² The Drug Administration Law provides for the same filing.¹

A later phase of an approved trial needs no fresh approval. Before starting it, the sponsor prepares the protocol, obtains the approval of the ethics committee and submits the protocol and supporting materials on the Center’s website.²

A change during the trial is assessed by the sponsor for its effect on subject safety. A change that leaves subject safety unaffected may be implemented directly and reported in the development safety update report. A change that may increase the risk to subjects requires a supplementary application, which is decided within 60 days and is treated as approved where no notice is given in time.²

A new indication is different. Article 27 requires a new clinical trial application where an approved investigational drug is to be studied for a further indication or in combination with another drug.²

Duties while the trial runs

Article 28 requires a development safety update report once a year, submitted within two months after each full year from approval.² The sponsor must also report suspected unexpected serious adverse reactions and other serious safety risks to the Center in good time.²

Article 22 of the Law applies where the sponsor finds a safety problem or other risk. The sponsor must adjust the protocol or suspend or end the trial, and must report to the regulator.¹ The regulator may order the same where necessary.¹ Article 30 of the Measures names the situations in which the sponsor can be required to adjust, suspend or end a trial.²

• the ethics committee has failed to perform its duties
• the safety of subjects cannot be effectively assured
• the sponsor has failed to submit the development safety update report as required
• the sponsor has failed to deal with and report a suspected unexpected serious adverse reaction in time
• there is evidence that the investigational drug is ineffective
• the investigational product has a quality problem
• there has been fraud in the conduct of the trial

Registration of the trial

Article 33 requires the sponsor to register the protocol and other information on the drug clinical trial registration and information disclosure platform before the trial is conducted.² The sponsor keeps the registration up to date during the trial and registers the results after it ends. The registered information is published, and the sponsor answers for its truthfulness.²

Where the trial may be run

Article 22 of the Measures requires a drug trial to be run at a trial institution that has the required conditions and has been filed as the rules provide.² A vaccine trial must be carried out or organised by a tertiary medical institution, or by a disease prevention and control institution at provincial level or above, that meets the conditions set by the national drug and health authorities.²

Human genetic resources

A trial that uses Chinese human genetic resources with a foreign party has a further step. An international cooperation trial run to obtain marketing authorisation in China needs a filing in place of approval where no material is exported. The filing is made before the trial begins.⁴ Article 51 of the Implementing Rules requires the clinical trial approval, notice or filing from the drug regulator to be in hand first.⁴ The National Health Commission has administered this regime since 1 May 2024. The Implementing Rules were issued by the Ministry of Science and Technology in 2023 and their text still names it.

When a permission lapses

Article 32 requires a trial to be carried out within three years of approval. Where no subject has signed an informed consent form within three years, the permission lapses of itself and a new application is needed.² Article 31 applies the same period to a suspended trial. The permission lapses where the suspension has lasted three years and no resumption has been applied for and approved.²

Penalties for an unapproved trial

Article 125 of the Law lists the conduct of a drug clinical trial without approval among its violations.¹ The penalty includes confiscation and a fine of RMB 500,000 to RMB 5 million. In a serious case the responsible persons are fined RMB 20,000 to RMB 200,000 and are barred from drug production and distribution for ten years or for life.¹

Questions people also ask

How long does China take to approve a clinical trial application?

The regulator must decide within 60 working days of accepting the application, and the application is treated as approved where no notice is given in that time.¹ The time an applicant takes to supplement its materials is left out of the count.²

Is a separate approval needed for phase II and phase III?

Article 26 of the Drug Registration Measures requires the sponsor to obtain ethics committee approval and to submit the protocol and supporting materials on the website of the Center for Drug Evaluation before a later phase.²

Does a bioequivalence study need approval?

A bioequivalence study is filed on the website of the Center for Drug Evaluation and is then run under the filed protocol.²

When does a clinical trial approval expire?

The permission lapses where no subject has signed an informed consent form within three years of approval.²

Which drugs qualify for the 30-working-day channel?

The channel is open to class 1 innovative drugs that meet one of three conditions in Announcement No. 86 of 2025.³ The applicant must undertake to start the trial within 12 weeks of approval.³

Footnotes

1. Drug Administration Law of the People’s Republic of China (revised 2019), Articles 19 to 22 and 125. http://www.gd.gov.cn/zwgk/wjk/zcfgk/content/post_2521598.html ↩ ↩² ↩³ ↩⁴ ↩⁵ ↩⁶ ↩⁷ ↩⁸ ↩⁹ ↩¹⁰ ↩¹¹

2. Measures for the Administration of Drug Registration (State Administration for Market Regulation Order No. 27), Articles 22 to 33, 96, 102, 103 and 125. https://www.gov.cn/zhengce/zhengceku/2020-04/01/content_5498012.htm ↩ ↩² ↩³ ↩⁴ ↩⁵ ↩⁶ ↩⁷ ↩⁸ ↩⁹ ↩¹⁰ ↩¹¹ ↩¹² ↩¹³ ↩¹⁴ ↩¹⁵ ↩¹⁶ ↩¹⁷ ↩¹⁸ ↩¹⁹ ↩²⁰ ↩²¹ ↩²² ↩²³

3. National Medical Products Administration, Announcement on Optimising the Review and Approval of Clinical Trials of Innovative Drugs, No. 86 of 2025. https://yjj.sh.gov.cn/qtgzwj/20250912/c840a6ddf1cf4c58a4855427d0f9f476.html ↩ ↩² ↩³ ↩⁴ ↩⁵ ↩⁶ ↩⁷ ↩⁸ ↩⁹ ↩¹⁰

4. Implementing Rules for the Regulations on the Administration of Human Genetic Resources (Ministry of Science and Technology Order No. 21), Articles 32 and 51. https://www.most.gov.cn/xxgk/xinxifenlei/fdzdgknr/fgzc/bmgz/202306/t20230601_186416.html ↩ ↩²