The Center of Drug Evaluation (CDE) issued a guideline One-time import of reference biological products for clinical trials, (no. 94 of 2018), To support and encourage the development of biosimilar drugs to better meet the public demand for drug use.
conditions for ‘one-time” importation:
NO 94 of 2018 states the referenced biological products that meet the following conditions may be imported at one time for clinical trial purpose.
- The biosimilar drugs whose registration have been approved in China, but can’t be obtained by pharmaceutical research and development institutions or production enterprises in China domestic market in a timely manner;
- The biosimilar drugs whose registration have NOT been approved in China but have been approved for clinical trials and listed abroad.
application for importation:
The CDE is responsible for handling the acceptance, examination and approval of one-time import of biological products for clinical trials.
The Applicant may submit:
- Application Form for The Approval of Imported Medicines
- Application Plan,[ including drug listed situation, drug source, specific use, quantity, usage plan and port of entry of drugs to be imported, etc.
- support materials for foreign approval for listing drug and other necessary materials
Once the application has been approved by the CDE the drug should to be imported through the importation port specified in the Importation Drug Approval License.
The applicant can then apply to the Port Food and Drug Administration for the Import Clearance Document.
The following documents (need to be sealed) should be provided for the application:
- Importation Drug Approval License.
- A copy of the legal registration certificate of the applicant’s institution (e.g. business license, organization code certificate, etc.).
- A copy of the certificate of origin;
- A copy of the contract for the goods;
- A copy of packing slip, bill of lading and freight invoice;
- Drug SmPC and packaging, labels (except API and excipients);