Port filing and testing for drugs imported into China

A registration certificate does not by itself bring a drug through Chinese customs. Each import is filed with the drug regulator at the port, which issues an import drug customs clearance form (进口药品通关单). Customs releases the goods against that form and may not release them without it.¹

Testing comes in at two points. Registration testing is part of the marketing application, with periods set in working days.² Port testing applies at import, before filing for three groups of drug and after it for the rest.³

The rule in the Drug Administration Law

Article 64 sets three requirements for an imported drug.¹

• The drug enters through a port at which drug import is permitted.
• The importing enterprise files with the drug regulator at the place of the port.
• Customs handles clearance against the customs clearance form issued by the drug regulator.

The ports are proposed by the national drug regulator with the General Administration of Customs, and approved by the State Council.¹ The port regulator notifies a drug testing institution to carry out sampling tests on imported drugs.¹

Article 68 requires testing by a designated institution before sale or at import for three groups. A drug in those groups may not be sold or imported untested or after a failed test.¹

• drugs sold in China for the first time
• biological products specified by the national drug regulator
• other drugs specified by the State Council

Where a registered drug is imported without the port filing, the regulator orders correction within a time limit and gives a warning. Where the importer still fails to correct, the drug registration certificate is revoked.¹

The filing procedure

The Measures for the Administration of Drug Import were issued on 18 August 2003 and took effect on 1 January 2004. They were amended in 2012.³

A drug must hold its import registration document before import filing and port testing can be handled.³ The entity that files must be an independent legal person holding a drug distribution licence. A manufacturer importing active ingredients or intermediates for its own use must hold a drug production licence.³

The filing entity submits an import drug inspection application form with the original registration document. Article 13 lists the materials that accompany it, which include the following.³

• a copy of the registration document
• copies of the filing entity’s drug distribution licence and business licence
• a copy of the certificate of origin
• a copy of the purchase contract
• copies of the packing list, the bill of lading and the freight invoice
• a copy of the manufacturer’s release test report
• the package insert and samples of the packaging and label

For a biological product subject to batch release, the filing adds a summary of the production and test records. It also adds the original batch release certificate from the drug authority of the country or region of production.³

The port regulator checks the materials and the original registration document. It returns the original and completes the filing on the same day.³

Two paths at the port

Article 10 of the Measures names the drugs that must pass port testing before filing. They are the same three groups as in Article 68 of the law.³ These drugs must enter through a port that the State has specially approved for them.³

	Drugs within Article 10	Other drugs
Order of events	Port testing, then filing	Filing, then port testing
Customs clearance form	Issued after the drug passes the test	Issued once the materials are found in order
Result of a failed test	Filing refused	Handled by the port regulator under the law

Announcement No. 12 of 2018 of the National Medical Products Administration narrows the second path for chemical drugs. It states that imported chemical active ingredients and preparations are no longer subject to compulsory testing batch by batch at import. Chemical drugs sold in China for the first time are excepted.

When filing is refused

Article 17 lists the grounds on which the port regulator refuses the filing. They include the following.³

• The original registration document cannot be produced, has expired or has been revoked.
• The drug has less than 12 months of shelf life remaining at the time of filing.
• The place of production on the certificate of origin differs from the place in the registration document.
• The packaging or label departs from the regulator’s rules.
• A preparation has no Chinese package insert, or the insert differs from the approved one.
• The drug was imported through a port that is not approved for drug import.
• Documents or receipts have been forged or altered.

A drug whose own shelf life is under 12 months must have at least 6 months remaining at filing.³ A drug that is refused must be returned abroad. Where return is impossible, customs passes it to the port regulator.³

Since 1 July 2025 the port regulator has made one further check at the first import filing of a drug. It checks that the package insert carries the details of the domestic responsible person designated by the overseas holder.⁴

Documents that travel with the drug

A supplier of an imported drug in China must give the buyer copies of two documents, stamped with its seal.³

• the registration document
• the import drug test report, or the customs clearance form marked as sampled

For a biological product subject to batch release, the supplier adds a copy of the batch release certificate issued by the port testing institute.³

Registration testing

Registration testing is separate from port testing and belongs to the marketing application. For a drug produced abroad, the National Institutes for Food and Drug Control organise port drug testing institutions to carry it out.² The applicant draws the samples as required. It sends the samples, the testing materials and the reference standards to the Institutes.²

An applicant may ask for registration testing before its application is accepted. It may do so once it has completed the pharmaceutical research, fixed the quality standard and validated the commercial-scale process.² Where it has not, the Center for Drug Evaluation starts registration testing within 40 days after acceptance.² In principle the applicant may ask only once before acceptance.²

Step	Period
Check of samples and materials, with a decision on receipt	5 working days
Sample testing	60 working days
Sample testing with verification of the standard	90 working days
Supplementing materials during testing	30 working days
Report to the Center for Drug Evaluation	In principle 40 working days before the review period ends

Periods in the Drug Registration Measures are counted in working days.² A testing institution may extend a period for special circumstances by up to one half of the original period. The head of the institution approves the extension, and the applicant is told in writing.²

Batches made before approval

Announcement No. 96 of 2025 is dated 29 September 2025. It concerns a drug that is marketed abroad and then approved in China. Commercial-scale batches made before the Chinese approval may be imported and sold after it, where the requirements are met.⁵ The drug must fall within one of six groups.⁵

• originator drugs and improved drugs
• drugs named in four national lists, which cover shortage drugs, generics to be encouraged and paediatric drugs
• drugs whose indications include a disease in the Rare Disease Catalogue
• drugs that were imported temporarily before approval under the scheme for drugs in urgent clinical need
• drugs approved in China through a faster registration procedure
• other drugs specified by the national drug regulator

Four conditions apply in addition to the Measures for the Administration of Drug Import.⁵

• The foreign regulator has permitted the drug to be sold.
• The quality standard, production site, production process, package insert and label match what the Chinese regulator approved.
• The batch was produced after a good manufacturing practice inspection was passed.
• The release document was signed after the approval in China.

The inspection may be one by China, by the place of production, or by a place where the drug is registered or has applied for registration.⁵

An innovative drug or improved new drug produced abroad may use the same route. Its import filing need not include the foreign regulator’s certificate permitting sale.⁵ The holder and its domestic responsible person submit the application letter and materials. Sales in breach of the announcement are handled by the provincial regulator where the domestic responsible person is located.⁵

Questions people also ask

What is an import drug customs clearance form?

It is the document issued by the drug regulator at the port after import filing. Customs handles clearance against it and may not release a drug without it.¹

Is every batch of an imported drug tested at the port?

Drugs sold in China for the first time and specified biological products must pass port testing before filing.³ Announcement No. 12 of 2018 states that other imported chemical drugs are no longer tested batch by batch at import.

How long does drug registration testing take in China?

Sample testing takes 60 working days, or 90 working days with verification of the standard. A period may be extended by up to one half.²

How much shelf life must an imported drug have?

Filing is refused where less than 12 months remain. A drug whose own shelf life is under 12 months must have at least 6 months remaining.³

Can stock made before approval be sold in China?

Announcement No. 96 of 2025 permits import and sale of commercial-scale batches made before approval, for six groups of drug and on four conditions.⁵

Footnotes

1. Drug Administration Law of the People’s Republic of China (revised 2019), Articles 64, 68 and 132. http://www.gd.gov.cn/zwgk/wjk/zcfgk/content/post_2521598.html ↩ ↩² ↩³ ↩⁴ ↩⁵ ↩⁶ ↩⁷

2. Measures for the Administration of Drug Registration (State Administration for Market Regulation Order No. 27), Articles 53 to 57, 98, 102 and 125. https://www.gov.cn/zhengce/zhengceku/2020-04/01/content_5498012.htm ↩ ↩² ↩³ ↩⁴ ↩⁵ ↩⁶ ↩⁷ ↩⁸ ↩⁹

3. State Food and Drug Administration and General Administration of Customs, Measures for the Administration of Drug Import, Order No. 4 of 18 August 2003, Articles 5, 6, 9 to 18, 34 and 45. https://www.gov.cn/gongbao/content/2004/content_63149.htm ↩ ↩² ↩³ ↩⁴ ↩⁵ ↩⁶ ↩⁷ ↩⁸ ↩⁹ ↩¹⁰ ↩¹¹ ↩¹² ↩¹³ ↩¹⁴ ↩¹⁵ ↩¹⁶

4. National Medical Products Administration, Interim Provisions on the Designation of Domestic Responsible Persons by Overseas Drug Marketing Authorisation Holders, Announcement No. 137 of 2024, Articles 13 and 18. https://www.gov.cn/zhengce/zhengceku/202411/content_6987154.htm ↩

5. National Medical Products Administration, Announcement No. 96 of 2025 on the import of commercial-scale batches made before approval of drugs marketed abroad, 29 September 2025. https://mpa.shaanxi.gov.cn/zfxxgk/fdzdgknr/zcfg/xzgfxwj/202601/t20260107_3603152.html ↩ ↩² ↩³ ↩⁴ ↩⁵ ↩⁶ ↩⁷