Partnering for Success in New Zealand Pharmacovigilance
If you are a pharmaceutical manufacturer, healthcare provider, or life sciences organisation operating in New Zealand, explore DDReg’s pharmacovigilance services in New Zealand to ensure drug safety and regulatory compliance. From adverse drug reaction reporting to complying with Medsafe pharmacovigilance guidelines, the right PV partner shapes everything: signal detection, risk management planning, safety reporting, and successful market authorisation.
Expert Pharmacovigilance Services for the New Zealand Market
The Medicines and Medical Devices Safety Authority (Medsafe) is the national regulatory authority responsible for pharmacovigilance in New Zealand. Under the Medicines Act 1981, Medsafe is legally required to supervise post-market safety surveillance of medicines and medical devices. Clinical trials cannot capture all adverse events, rare or long-term effects often emerge only once products are used widely. Medsafe ensures continuous monitoring, evaluation, and action on safety information for approved products.
How Pharmacovigilance Works in New Zealand?
- Reporting of ADRs: Anyone, the public, health professionals, and the therapeutic goods industry, can report adverse drug reactions to the Centre for Adverse Reactions Monitoring (CARM), which is contracted by Medsafe. Reports can be submitted online, by phone, post, fax, or email. Reporting is mandatory for sponsors of both registered and listed drugs, and voluntary for clinicians and the public.
- New Zealand Pharmacovigilance Database: In September 2023, Medsafe moved the collection, processing, and storage of ADR reports from CARM’s old system to a new NZ Pharmacovigilance Database. CARM continues to assess serious and non-routine reports.
- Focus Areas: Medsafe focuses on adverse events associated with new drugs, drug-vaccine interactions, unlisted or unexpected adverse events, and serious events such as death, hospitalisation, or congenital defects.
- Evaluation / Causality Assessment: Medsafe, often via CARM, assesses the causality of suspected ADRs using WHO causality assessment criteria. Even if causality is unconfirmed, these reports help build safety data and may trigger regulatory actions.
Why Choose DDReg as Your Pharmacovigilance Services Provider in New Zealand?
DDReg is your local partner offering pharmacovigilance consulting firm in New Zealand standards, with global best practices. We ensure that your pharmacovigilance safety New Zealand compliance is seamless, efficient, and proactive. Our area of expertise includes pharmacovigilance outsourcing New Zealand obligations, risk-based safety measures, and communication of safety information.
Our Pharmacovigilance & Drug Safety Services in New Zealand Include:
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ICSR Processing & Submission
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Risk Management Plan (RMP)
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Aggregate Reports
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Signal Management
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Local Pharmacovigilance Services in New Zealand
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PV Quality Management System Oversight & Compliance
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