Streamlining the Approval Process for Medicines That Are or Contain New Organisms

This paper provides advice to Ministers on proposed amendments to the Hazardous Substances and New Organisms (HSNO) Medicines, and Agricultural Compounds and Veterinary Medicines (ACVM) Acts arising from recommendations of the Royal Commission on Genetic Modification. It covers amendments to streamline the assessment process for animal and human medicines that are or contain new organisms, and proposes the introduction of a scheme to allow regulatory agencies to quickly assess and approve agricultural compounds and medicines required urgently to manage an emergency.