{"id":42565,"date":"2025-09-30T16:29:07","date_gmt":"2025-09-30T08:29:07","guid":{"rendered":"https:\/\/flcube.com\/?p=42565"},"modified":"2025-09-30T16:29:08","modified_gmt":"2025-09-30T08:29:08","slug":"nmpa-announces-import-of-commercial%e2%80%91scale-pre%e2%80%91approval-overseas-drugs","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=42565","title":{"rendered":"NMPA Announces Import of Commercial\u2011Scale Pre\u2011Approval Overseas Drugs"},"content":{"rendered":"\n

The National Medical Products Administration (NMPA)<\/strong> has issued a new regulatory framework, titled \u201cAnnouncement on Matters Concerning the Import of Commercial\u2011Scale Batches of Pre\u2011Approval Products of Overseas Marketed Drugs.\u201d<\/em> The directive allows foreign\u2011origin drugs that have already received marketing approval overseas to be imported into China after<\/strong> China\u2019s own approval of the product, provided the commercial\u2011scale batches were produced before the domestic approval was granted.<\/p>\n\n\n\n

Key Eligibility Criteria<\/h2>\n\n\n\n

A drug may qualify for import under one of the following conditions:<\/p>\n\n\n\n

    \n
  1. Original or Improved New Drugs<\/strong> \u2013 novel therapeutics or enhanced versions of existing treatments.<\/li>\n\n\n\n
  2. Strategic National Lists<\/strong> \u2013 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.<\/li>\n\n\n\n
  3. Rare Disease Indications<\/strong> \u2013 drugs whose indications are catalogued under China\u2019s Rare Disease Catalogue.<\/li>\n\n\n\n
  4. Temporary Import Pre\u2011Approval<\/strong> \u2013 products that received a temporary import license before full marketing approval, as per the Work Plan for the Temporary Import of Clinically Urgent Drugs<\/em>.<\/li>\n\n\n\n
  5. Expedited Marketing Authorization<\/strong> \u2013 drugs approved via China\u2019s expedited pathway under the Measures for the Administration of Drug Registration<\/em>.<\/li>\n\n\n\n
  6. Other State Council\u2011Specified Drugs<\/strong> \u2013 any additional categories defined by the State Council\u2019s drug regulatory department.<\/li>\n<\/ol>\n\n\n\n

    Regulatory Safeguards<\/h2>\n\n\n\n