Medsafe oversees pharmaceutical product regulation in New Zealand and operates under the Medicines Act 1981 which mandates sponsors to report substantial untoward effects of their medicines. The requirement for regulations are highlighted in the Guidelines on the Regulation of Therapeutic Products in New Zealand (GRTPNZ) which also has a Pharmacovigilance (PV) guidance document. This provides PV related obligations for sponsors that have their products on the market in New Zealand. In March 2024, updates to the guideline were published under “Guideline on the Regulation of Therapeutic Products in New Zealand: Pharmacovigilance (Edition 3.0) which come into effect from 1st July 2024.
Overview of New Zealand’s position in global pharmacovigilance
New Zealand participates in the WHO International Drug Monitoring Programme and maintains its pharmacovigilance system through Medsafe. They gather post-market safety information through spontaneous reporting and various other sources. The Medicines Adverse Reaction Committee (MARC), composed of experts, advises Medsafe on safety issues and contributes to improving risk-benefit profiles of medicines. Medsafe takes regulatory actions based on safety evaluations, including communication with healthcare professionals and the public, data sheet updates, and suspending medicine distribution or revoking the consent if necessary.
Sponsor’s Responsibilities
Sponsors in pharmacovigilance must keep a system to collect and review safety information on their medicines. They have to appoint a contact person for pharmacovigilance to ensure proper reporting of Individual Case Safety Reports (ICSRs) and manage contractual agreements with stakeholders involved in medicine distribution. Adverse reactions (particularly serious ones) should be reported to the New Zealand Pharmacovigilance Database within 15 days of receipt according to specific reporting guidelines and validation criteria.
Information access on suspected adverse reactions in New Zealand is facilitated through the Suspected Medicine Adverse Reaction Search (SMARS) database which is updated monthly. Occasionally some anonymized information is released under the Official Information Act, ensuring transparency while safeguarding individual privacy.
Signal Management
Signal management covers many actions that aim to identify, confirm or refute, quantify the risk of and understand contributing factors of safety signals associated with drugs. Signals can originate from several sources such as individual case safety reports (ICSRs), data collected by monitoring systems in large numbers over time, reviews of published scientific literature papers about the drug’s use in patients like oneself as well as studies done before it was licensed clinically. Whenever there is an indication that may be valid for investigation, Investigations should follow in order not only to determine whether there really exists any hazard but also to find out how much danger is involved.
Safety Issue Reporting
Medsafe must be given notice by sponsors about important safety issues (SSIs) and other safety issues (OSIs). Urgent attention is required for SSIs, and they should be reported within 72 hours (3 days); on the other hand, OSIs can be reported within 30 calendar days following their awareness by the sponsor.
Safety can be monitored continuously by requesting Periodic Benefit-Risk Evaluation Reports (PBRERs) and Risk Management Plans (RMPs) for some medications. The main function of PBRERs is to ensure that the benefit-risk ratio of drugs remains positive in peoples’ minds, whereas RMPs provide plans on how to deal with dangers linked to medicine and reduce them.
Timely and accurate safety communications are essential for providing relevant information to healthcare professionals and the public. Communication strategies should be transparent, evidence-based, and tailored to the target audience, utilizing various channels such as Dear Healthcare Professional (DHCP) letters, bulletins, newsletters, and social media.
Conclusion
Adherence to best practice guidelines, both internationally and nationally, is essential for sponsors to ensure the safety and efficacy of medicines throughout their lifecycle. New Zealand is dedicated to protecting its people’s health as well as upholding medication safety standards. This includes establishing strong pharmacovigilance systems with help from regulatory agencies, sponsors, and healthcare workers working together.
DDReg brings over 15 years of experience in pharmacovigilance including establishing robust systems to ensure compliant and efficient safety evaluation. Reach out to our experts for end-to-end pharmacovigilance services: Read more from our experts global PV experts: Kenya’s Systematic Approach to Pharmacovigilance.