New Rules on Local Production of Imported Drugs in China

June 03, 2024 | BY

Susan Mok

Fang Jianwei, Lv Chao and Yuan Chenhao of Zhong Lun Law Firm in Shanghai explain the background and impact – including on multinational companies – of a set of new rules governing the local production of imported drugs

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Summary

  • New rules issued by the National Medical Products Administration aim to encourage the local production of certain pharmaceutical products
  • Chinese applicants are specifically targeted by the rules
  • Priority review and conditional approval procedures are applied under specific conditions by the rules
  • Multinational pharmaceutical companies are likely to find themselves impacted; finding local partners will be essential in some cases