Medsafe is responsible for regulating pharmaceutical products in New Zealand and operates under the Medicines Act of 1981, which requires sponsors to report any significant adverse effects of their medications. This requirement is outlined in the “Guidelines on the Regulation of Therapeutic Products in New Zealand” (GRTPNZ), which also includes a Pharmacovigilance (PV) guidance document. This document details the PV responsibilities for sponsors whose products are on the market in New Zealand. An update to the guidelines was published in March 2024 under the “Guideline on the Regulation of Therapeutic Products in New Zealand: Pharmacovigilance (Edition 3.0)” and will come into effect on July 1, 2024.
New Zealand’s Role in Global Pharmacovigilance
New Zealand participates in the WHO International Drug Monitoring Programme, maintaining its pharmacovigilance system through Medsafe. They collect post-market safety information via spontaneous reports and other sources.
The Medicines Adverse Reaction Committee (MARC), a group of experts, advises Medsafe on safety concerns and helps improve the risk-benefit balance of medicines. Based on these safety assessments, Medsafe may take regulatory actions such as informing healthcare professionals and the public, updating product data sheets, or even suspending or revoking the approval of a medicine if necessary.
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https://resource.ddregpharma.com/blogs/pharmacovigilance-in-new-zealand/
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