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The Regulation of Medical Nitrous Oxide.

  • Data Source:Food and Drug Administration, Ministry of Health and Welfare
  • Created:2022-01-10
  • Last Updated:2022-01-19
Nitrous Oxide, also known as “laughing gas”, is a gas used as an anesthetic in medicine. The Ministry of Health and Welfare has recognized nitrous oxide for medical purpose as medicinal product since 2010. For the manufacture and import of medical nitrous oxide shall apply to the central competent health authority (Ministry of Health and Welfare) for registration and obtain marketing authorization according to the provisions of the Pharmaceutical Affairs Act. Currently there are two valid licenses, and the approved indication is “for inhalational anesthesia and analgesia”. Their manufacturing and distribution are required to comply with the good manufacturing practice (GMP) and the good distribution practice (GDP). 
Because of its narcotic effect, it can relieve pain and even produce euphoria, nitrous oxide is commonly called “laughing gas”. In addition to being medically used as an anesthetic, laughing gas is also widely used in food processing and industrial applications. To prevent people from misusing it for recreation, TFDA strictly control the supply chain of medical nitrous oxide. TFDA announced to include medical nitrous oxide in the list of sales information to be reported to TFDA, and the announcement came into effect on October 1st, 2020. Pharmaceutical companies, no mater manufacturers, wholesalers, or retailers are required to report every sales detail unto the TFDA track and trace electronic platform system. 
TFDA is determining to protect and improve the health of each citizen. Due to the aforementioned measures, so far, there has been no report on the abuse of medical nitrous oxide. However, the abuse of industrial nitrous oxide still occurs occasionally, especially among young people. Hopefully, the young people can understand the serious harm of laughing gas and avoid to the abuse of nitrous oxide.