Pharmacovigilance in New Zealand
How is it with the drug safety system in the Aotearoa? Read our guide to get a clear picture.
And of course, if you feel you need a local consultant, we’re here for you.
Current status of our New Zealand’s pharmacovigilance services:
Contact person in New Zealand
AVAILABLE
Easily managed through Tepsivo Platform >
Local Literature Screening
AVAILABLE
Automated monitoring with Tepsivo Literature >
Who is the main PV authority in New Zealand?
RESPONSIBILITY FOR NATIONAL PV SYSTEM
The main authority responsible for pharmacovigilance in New Zealand is Medsafe, which is the regulatory unit of the Ministry of Health.
Medsafe monitors the safety of medicines and vaccines after they have been approved for use in New Zealand. The agency does not have any regional centres.
Interesting website sections related to pharmacovigilance
EVALUATION & APPROVAL PROCESS
Very user-friendly and clear guide, that explains you everything reagrding the topics in the title, such as how are medicines approved, how long does it take, what the process even is and much more.
FORMS TO DOWNLOAD
Section with all the important forms, all can be downloaded and it’s really easy to navigate there, they’re sorted into individual categories, so no problem finding the one you’d like.
PRODUCT/APPLICATION SEARCH
Huge database that enables you to search for any product that has received approval for sale in New Zealand or applications submitted to Medsafe since 2006.
CONSUMER MEDICINE INFORMATION (CMI)
Another databse, this time it basically allows you to find a leaflet that provides information on the safe and effective use of medication.
IS MY PRODUCT A MEDICINE?
If you’d like to market a product in New Zealand, the first step is to determine whether your product qualifies as a medicine and to do so, use this linked page, where is a guide how to do it.
Other important institutions & industry groups
MINISTRY OF HEALTH
This the primary public service department in New Zealand responsible for healthcare policy, regulation, and oversight. Nontheless it is also responsible for overseeing the healthcare system, ensuring that citizens have access to high-quality healthcare services.
There is a really vast section called “Statistics and data sets”, thath includes data on practically every area regarding health you can imagine, so definitely head here and see the area that’s most interesting for you. Results of New Zealand Health Survey were recently published and we recommend to go through it, you can see just the key indicators or explore only those topics, that you’re keen on. Also if you want to read about the new Health Strategy, you can do so here.
Ministry’s website: https://www.health.govt.nz/
MEDICINES NEW ZEALAND
This is the primary industry association representing manufacturers of modern prescription medicines. It advocates for improved access to innovative therapies and collaborates with health decision-makers to enhance the pharmaceutical landscape.
Their website contains two section, that we can mention. The first is Publications, where you can find many materials regarding New Zealand’s Health System or Medicine Landscape. The second one contains general information about the industry, such as environment, clinical trials and so on, there are also some guidelines, namely on clinical trials or transparency.
Association’s website: https://www.medicinesnz.co.nz/
HEALTH NEW ZEALAND
Established to oversee the delivery of health services, it aims to provide a more integrated health system.
If you want to get more information on New Zealand’s Health System, head into this section, there awaits you intel on health targets, structure, innovation and more. There is also a section dedicated to statistics, it does not contain them though, but it rather gives you direction where to find them. For example, if you’re interested in Pharmaceutical ones, there is website called “Pharmaceutical Data web tool” and that’s where the statistics are located. Don’t worry all of this is very user-firendly and tehre are also guides how to work with these sites. Also if simply want some publications regarding health, they got section for that too.
Their website: https://www.tewhatuora.govt.nz/
PHARMACEUTICAL SOCIETY OF NEW ZEALAND
This organization represents pharmacists and aims to promote the role of pharmacists in healthcare. It provides professional support and advocates for pharmacy practice standards.
If you’d like to get to know this society better, then head to this section, where annual reports, strategy & vision and more are being held. As always, there is News section on the industry and, which is not seen that much often, there are two podcasts. Sadly, neither of them seems to be published anymore, but you may find some episodes interesting.
Society’s website: https://www.psnz.org.nz/
Some of the most important laws
Basic legislation
This foundational legislation outlines the regulatory framework for medicines in New Zealand.
This legislation governs the handling of personal information, including data related to adverse drug reactions.
Guidelines
Guideline on the Regulation of Therapeutic Products in New Zealand (GRTPNZ): Pharmacovigilance
This guideline outlines the responsibilities of sponsors regarding pharmacovigilance, including obligations for reporting adverse reactions and conducting safety monitoring. It emphasizes continuous safety monitoring for both approved and unapproved medicines.
Outlines the standards and guidelines that manufacturers must follow to ensure the quality and safety of therapeutic products.
Local pharmacovigilance specifics
Useful abbreviations to know
If you want to study local materials about pharmacovigilance in New Zealand, following terms will be helpful for you to get familiar with:
SMARS (Suspected Medicine Adverse Reaction Search)
→ databse containing anonymised information from reports of suspected adverse reactions to medicines
CMI (Consumer Medicine Information)
→ a leaflet that provides information on the safe and effective use of a prescription medication or certain over-the-counter drugs
CARM (Centre for Adverse Reactions Monitoring)
→ national repository for adverse reaction reports
Is Qualified Person Responsible for Pharmacovigilance needed?
Medsafe requires pharmaceutical companies marketing medicines in New Zealand to appoint a contact person responsible for pharmacovigilance activities.
This requirement is outlined in the Guidelines on the Regulation of Therapeutic Products in New Zealand (GRTPNZ). The contact person should preferably be located in New Zealand or at least be contactable during normal New Zealand business hours.
How can be adverse events reported in New Zealand?
The primary method for reporting suspected ADRs is through the New Zealand Adverse Reactions Reporting Form, which can be accessed online at the Centre for Adverse Reactions Monitoring (CARM) website. Healthcare professionals and consumers are encourage to report suspected adverse reactions.
Local medical journals to screen
Here are few examples of New Zealand’s local literature that medical authorization holders should monitor:
THE NEW ZEALAND MEDICAL JOURNAL (NZMJ)
Established in 1887, the NZMJ is a peer-reviewed journal that publishes a wide range of medical research, including original articles, case reports, and editorials.
It is notable for its focus on issues relevant to New Zealand’s healthcare landscape and is a key resource for medical professionals in the country.
ISSN: 1175-8716
AUSTRALIAN AND NEW ZEALAND JOURNAL OF MEDICINE
This journal focuses on internal medicine and provides a platform for research that influences clinical practice across Australia and New Zealand.
It is particularly valuable for its rigorous peer-review process and its emphasis on high-quality clinical research.
ISSN: 0004-8291
Rather then spending your budget for hours of repetitive manual work to monitor those sources, we recommend to simply automate this task using our Tepsivo Literature solution.
Other interesting resources
Medsafe’s performance
Explore Medsafe’s performance statistics regarding these evaluations of new and changed medicines.
Scientific publications regarding pharmacovigilance
Synthetic cannabis: adverse events reported to the New Zealand Pharmacovigilance Centre
Curious about the hidden dangers of synthetic cannabinoids? This study reveals alarming insights into the adverse reactions reported in New Zealand, highlighting a significant prevalence among young males and Māori, while uncovering the serious psychiatric effects linked to these substances.
Ever wondered how safe natural health products really are? This study dives into the challenges of monitoring these products in pharmacies, revealing surprising recruitment struggles and offering insights on how to improve participation—perfect for anyone interested in the safety of what we consume!
Curious about how different age groups misuse medications? This study sheds light on alarming trends in medicine exposures in New Zealand, revealing that children often explore their surroundings while youth frequently engage in self-poisoning.
interesting resources
Medsafe’s journal designed for healthcare professionals, offering important information about safety issues related to medicines and medical devices.
The official Government newspaper.
This page contains basic staticsits about New Zealand in various fields such as Population, Life expectancy or Health statistics.
Do you need some help with putting the New Zealand’s PV System together? We’re here for you.
And while you’re here…
…consider also our global end-to-end PV solution!
Thanks to the Tepsivo platform, you can get a full pharmacovigilance system in all countries you need – for a fraction of the usual budget.
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