China Institute for the Control of Pharmaceutical and Biological Products is responsible for providing technical guidance to the port drug inspection office and ruling on the disputed inspection results. Article 4 Imported drugs must be safe and effective varieties for domestic medical needs. Chapter II Registration of Imported Drugs Article 5 The State practices a registration system for imported drugs. All imported drugs must have an imported drug registration certificate issued by the Ministry of Health. The Import Drug Registration Certificate is valid for the product name, country of manufacture and manufacturer indicated on the certificate.
For varieties that have special medical needs or whose domestic production cannot meet the medical needs, but have not yet obtained the Import Drug Registration Certificate, the importing entity shall report to the Ministry of Health for examination and approval, and issue a one-time import drug approval number. The approval document for one-time drug import is only valid for the name, manufacturer, quantity, time limit and port drug inspection office specified in the approval document. Article 6 A foreign production enterprise or business enterprise applying for the Import Drug Registration Certificate shall apply, fill in the Application Form for Import Drug Registration Certificate in duplicate, and submit it to the Drug Administration of the Ministry of Health together with the required materials. If there is a special need for one-time import, the domestic importer shall submit an application together with the required materials, which shall be submitted to the Drug Administration of the Ministry of Health for examination and approval after preliminary examination by the health department (bureau) of the province, autonomous region or municipality directly under the Central Government. Article 7 To apply for the registration certificate of imported drugs, the following materials shall be submitted:
1. A certificate issued by the health authorities of the drug-producing country approving the production, sale and export of the drug and conforming to the good manufacturing practice (GMP), with a Chinese translation attached;
2. Certification documents of patented goods;
3. Drug instructions and Chinese translation;
4. Technical data;
(1) drug prescription, including effective ingredients, names of auxiliary materials (including non-patented names, trade names and chemical names) and dosage, etc.
(2) Methods of drug production;
(3) drug quality standards and inspection methods, with Chinese translation;
(4) Abstracts and documents of pharmacological and toxicological experiments of drugs;
(5) Clinical data of the drug, including indications, dosage, route of administration, compatibility with other drugs, side effects, contraindications and precautions;
(6) Experimental data of drug stability.
5. Drug samples;
6. Packaging materials and packaging samples. Article 8 If the quality standards attached to the application for the registration certificate of imported drugs are enterprise standards not included in the Pharmacopoeia or the regulations on biological products, the production enterprise shall provide three batches of samples and send them to the port drug inspection office designated by the Drug Administration of the Ministry of Health for recheck of drugs and their quality standards, and the recheck can only be carried out after they meet the requirements. Article 9 Drugs imported for the first time need to be clinically tested or verified in China. Article 10 The registration certificate of imported drugs shall be valid for three years from the date of issuance. Upon the expiration of the validity period, foreign production enterprises or business agents may apply for replacement, but they must submit the registration certificate to the original license issuing agency six months before the expiration of the validity period, and attach the documents, instructions and quality standards approved by the producing country for the production and sale of the drug. Only after examination and approval can they be replaced.
If the quality standard, production technology, indications and instructions of imported drugs are modified, the production enterprise shall submit the relevant information to the Drug Administration of the Ministry of Health for review in time. Chapter III Contracts and Quality Standards for Imported Drugs Article 11 Foreign trade entities importing drugs must have the License for Pharmaceutical Trading Enterprises issued by the administrative department of health and sign contracts with foreign countries in accordance with these Measures. The importer shall, within/0/5 days after signing the contract, submit the copy of the contract and the copy of the Registration Certificate of Imported Drugs or the approval number of disposable imported drugs to the port drug inspection office. Article 12 A contract for the import of drugs must specify the quality standards. The quality standard of imported drugs should be the current version of People's Republic of China (PRC) Pharmacopoeia, the drug standard of the Ministry of Health or the internationally accepted Pharmacopoeia. If the above pharmacopoeia or standards are not included, the quality standards approved by the Ministry of Health when issuing the Registration Certificate of Imported Drugs shall be adopted. The importer shall submit the standards to the drug inspection office at the port of arrival in time before the arrival of the goods. Article 13 All special reagents, standards or reference substances required for the inspection of imported drugs shall be indicated in the contract and provided by the seller. Chapter IV Inspection of Imported Drugs Article 14 After the drugs arrive at the port, the importing unit or the transshipment unit shall timely declare the inspection to the port drug inspection office, fill in the Inspection Form for Imported Drugs, and attach the invoice, packing list, waybill, quality certificate issued by the manufacturer, etc. The customs shall release the imported goods with the seal stamped by the port drug inspection office. Store it for temporary inspection. Article 15 The inspection applicant shall, within 7 days after the customs release, agree on the sampling date with the port drug inspection office and * * * go to the inventory site for sampling. Sampling shall be handled in accordance with the Provisions on Sampling of Imported Drugs and the Provisions on Sampling of Imported Medicinal Materials respectively. The inspection unit shall not allocate, sell or use it before receiving the report that the port drug inspection office has passed the inspection.