NMPA Announces Import of Commercial‑Scale Pre‑Approval Overseas Drugs

The National Medical Products Administration (NMPA) has issued a new regulatory framework, titled “Announcement on Matters Concerning the Import of Commercial‑Scale Batches of Pre‑Approval Products of Overseas Marketed Drugs.” The directive allows foreign‑origin drugs that have already received marketing approval overseas to be imported into China after China’s own approval of the product, provided the commercial‑scale batches were produced before the domestic approval was granted.

Key Eligibility Criteria

A drug may qualify for import under one of the following conditions:

1. Original or Improved New Drugs – novel therapeutics or enhanced versions of existing treatments.
2. Strategic National Lists – drugs on the National List of Drugs in Short Supply, the National Key Monitoring List of Clinically Essential and Easily Scarce Drugs, the Catalogue of Encouraged Generic Drugs, or the Pediatric R&D & Application list.
3. Rare Disease Indications – drugs whose indications are catalogued under China’s Rare Disease Catalogue.
4. Temporary Import Pre‑Approval – products that received a temporary import license before full marketing approval, as per the Work Plan for the Temporary Import of Clinically Urgent Drugs.
5. Expedited Marketing Authorization – drugs approved via China’s expedited pathway under the Measures for the Administration of Drug Registration.
6. Other State Council‑Specified Drugs – any additional categories defined by the State Council’s drug regulatory department.

Regulatory Safeguards

• GMP Compliance – All commercial‑scale batches must meet Good Manufacturing Practice standards. Evidence of GMP compliance must be provided through a drug inspection notification or a GMP certificate from the country of origin.
• Post‑Approval Release – Import filing is only permissible once the drug has received a China drug approval document (or a supplemental approval).
• Submission Requirements – Companies must adhere to the NMPA’s drug registration documentation guidelines when filing for import.

Strategic Impact

The announcement is designed to accelerate the early supply of innovative, rare‑disease, and short‑supply drugs to Chinese patients, while maintaining rigorous quality controls. By allowing pre‑approval commercial batches to enter the market post‑approval, the NMPA aims to reduce treatment gaps and support the domestic pharmaceutical ecosystem without compromising safety.-Fineline Info & Tech