Customs clearance tips for imported pharmaceutical excipients

Release time:

2024-03-07 15:39

With the upgrading of demand for generic drugs and innovative drugs, more and more manufacturers realize that pharmaceutical excipients have a great impact on the quality of drugs. Many importers are not clear about what materials and procedures need to be prepared during the customs clearance of imported pharmaceutical excipients. The following is a sharing of relevant customs clearance procedures.

Customs clearance information:

According to the Circular of the General Administration of Food and Drug Administration on matters related to the import and customs clearance of excipients for traditional Chinese medicine in the list of imported drugs (No. 31 of 2017) issued by the State Food and Drug Administration ". For the pharmaceutical excipients in the list of imported drugs, the importing unit may go to the port food and drug regulatory department to handle the "Customs Clearance Form for Imported Drugs" with the approval certificate of pharmaceutical excipients, photocopy of business license, packing list, bill of lading, factory inspection report and other materials. The food and drug regulatory department at the port shall indicate in the Customs Clearance Form for Imported Drugs that "this product is a pharmaceutical excipient, not a drug, and does not require port inspection.

The approval documents of pharmaceutical excipients shall include one of the following contents:

(I) the Registration Certificate of Imported Drugs for the import of pharmaceutical excipients, and after the expiration of the registration certificate, the imported pharmaceutical excipients can continue to be used in the original drugs;

(II) the approval number or acceptance notice of pharmaceutical excipients obtained according to the notice of the general administration on matters related to the review and approval of pharmaceutical excipients and drugs (no 134 of 2016);

(III) pharmaceutical excipients disposable import approval;

(IV) other approval documents that allow the import of pharmaceutical excipients.

The newly revised "Medical Device Management Quality Management Standard" will be implemented on July 1, and these changes need attention.

The two departments issued and implemented the first supplement to the Pharmacopoeia of the People's Republic of China (2020 Edition)

The newly revised "Medical Device Management Quality Management Standard" will be implemented on July 1, and these changes need attention.

The two departments issued and implemented the first supplement to the Pharmacopoeia of the People's Republic of China (2020 Edition)

Latest developments

Key Illustration of Railway Transportation Regulations for Consumer Lithium Battery Cargo

Recently, the Ministry of Industry and Information Technology of the National Railway Administration China National Railway Group Co., Ltd. announced the guidance on the railway transportation of consumer lithium battery goods. For details, please refer to our public article. Official

Answers to Frequently Asked Questions about the Environmental Management Measures for New Chemical Substances (Order No.7)

I recommend: For pre-registration projects with large tonnage and short grace period, or small tonnage pre-registration projects that are clearly registered in the future, it is recommended to choose joint registration and join the joint registration IT system agreement this time. For pre-registration projects that are clearly not registered in the future, it is recommended to choose subsequent registration. May I ask you

Cancellation of GMP certification means stricter supervision of drug production?