First efforts at regulating drugs in institutions

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First efforts at regulating drugs in institutions

After two rounds seeking feedback in 2010, the State Food and Drug Administration (SFDA) in October 2011 issued measures to regulate drugs in medical institutions for the first time. The Interim Measures for Drug Supervision and Management in Medical Institutions, effective from 11 October 2011, include provisions on the purchase, storage, dispensing and preparation, and use of drug products in medical institutions, as well as the supervision, inspection and enforcement of processes by local drug administrations.

Medical institutions are licensed as such under the PRC Medical Institution Administrative Regulations, and include everything from general hospitals in big cities to village clinics and disease prevention stations in rural areas.

Under the Interim Measures, a medical institution must:

  • Have a special unit or specific people to regulate drug quality, and report annually to the local drug administration on drug quality, changes in drug preparations and any changes inspectors require
  • Purchase drugs centrally via a specialised department
  • Purchase drugs only from companies holding drug production or drug distribution licences
  • Document all drugs purchased, and their sources
  • Follow the Drug Administration Law and regulations when importing small quantities of drugs for clinical emergencies
  • Inspect all drugs received, including from other medical institutions in emergencies
  • Have qualified pharmaceutical professionals verify and dispense all prescriptions
  • Use only drug preparations it prepares, unless a provincial level drug administration approves
  • Stop using and report drugs that are fake, substandard or suspected to be unsafe
  • Not sell prescription drugs directly to the public, by mail order, internet, open-shelf or otherwise

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Business Law Digest is compiled with the assistance of Baker & McKenzie. Readers should not act on this information without seeking professional legal advice. You can contact Baker & McKenzie by e-mail at danian.zhang@bakermckenzie.com