Medsafe (the New Zealand Medicines and Medical Devices Safety Authority)
Who regulates medicines in New Zealand?
In one sentence
Medsafe is New Zealand's regulator of medicines and medical devices: a business unit of the Ministry of Health, around 60 people strong.
It administers the Medicines Act 1981, under which a new medicine needs the Minister of Health’s consent. Its reporting centre is older than the agency: the Centre for Adverse Reactions Monitoring (CARM) in Dunedin dates from 1965 and helped found the World Health Organization (WHO) monitoring programme in 1968.
Where it sits
- MinisterThe Minister of Health, who consents to new medicines
- MinistryMinistry of Health, whose Director-General receives the reports in law
- Business unitMedsafe, Wellington and Auckland
- AssessorCARM, University of Otago, DunedinSerious reports are assessed here, under contract
Think of it like this
Think of a weather station older than the weather service. The station in the south has logged every storm since 1965, and the small office in the capital that runs the service still calls it to read the instruments.
Key insights
Medsafe is not an agency of its own but a unit of the Ministry of Health with around 60 staff. It administers the Medicines Act 1981 and its 1984 regulations; a new medicine needs the Minister’s consent, a changed one the Director-General’s. For the work industry pays fees for, it is accountable to industry too.
The reporting centre, CARM, was set up at the University of Otago in 1965 and was one of ten founding members of the WHO programme in 1968. Medsafe only got its name in July 1998. It contracts CARM to assess the serious reports. Chapter 1 tells the story.
A sponsor sends a valid serious case from a patient in New Zealand within 15 calendar days; a significant safety issue within 72 hours; any other safety issue within 30 days. Non-serious and overseas cases are not asked for. In 2024 the database took 4,585 reports, 63 percent of them serious. Chapter 2 sets the clocks.
A Therapeutic Products Act to replace the 1981 law received assent on 26 July 2023 and was repealed on 18 December 2024 without ever commencing. Medsafe regulates under the old Act, sits in the International Coalition of Medicines Regulatory Authorities (ICMRA) and joined the Pharmaceutical Inspection Co-operation Scheme (PIC/S) in 2013.
Jump to: 1 Three moments 2 Your report, their clock 3 Side by side with Europe 4 Test yourself
Chapter 1
Which three moments made Medsafe what it is?
Pick a year. Each explains why a country of five million runs pharmacovigilance this way.
A reporting centre before a regulator
In 1963 the World Health Assembly, shaken by thalidomide, called for systematic collection of serious adverse reactions. New Zealand answered in 1965 with a centre at the University of Otago in Dunedin, the Centre for Adverse Reactions Monitoring. When the WHO programme began in 1968, CARM was one of its ten founding members.
The regulator came later and never absorbed it. Medsafe contracts CARM to collect and assess the serious reports, using the WHO causality criteria, and CARM’s medical assessors can enter an alert against a patient’s National Health Index number so the next hospital sees it. In 2000/1 the centre received 3,333 reports.
What it left behind: a national database read by a university, not by the ministry that owns it.
The Therapeutics Section gets a name
The Medicines Act 1981 replaced the Food and Drug Act of 1969, and for 17 years a section of the health ministry ran it. In July 1998 the Therapeutics Section was relaunched as Medsafe, with one of the first New Zealand Government websites. In the early 2000s it had three teams and 49 staff.
The Act it administers is where the reporting duty lives: section 41 obliges importers and manufacturers to report any substantial untoward effect of their medicines to the Director-General of Health, who has delegated the receiving to Medsafe. A statutory committee of outside experts, the Medicines Adverse Reactions Committee, meets four times a year to advise.
What it left behind: a regulator that is still a section of a ministry, and a duty that still points at the Director-General.
A new Act, repealed
New Zealand has tried more than once to leave the 1981 Act behind. A joint agency with Australia was proposed in 2002, postponed in 2007 and reopened in 2011, without result. Then the Therapeutic Products Act 2023 received assent on 26 July 2023, promising one life-cycle law for medicines, devices and natural health products.
It never commenced. A new government’s Repeal Act received assent on 17 December 2024 and struck the 2023 Act out the next day. What did change was the plumbing: since 1 October 2023 reports go to a new national database that Medsafe commissioned, which triages them and forwards the serious ones to CARM.
What it left behind: the Medicines Act 1981, still in force, and a 2023 database under a 1981 law.
Chapter 2
Your report, their clock
A case has reached your company. Medsafe’s guidance sets the deadline with two questions: is it serious, and was the patient in New Zealand? Pick a cell.
Or it is not a single case: or
A valid serious case from a patient in New Zealand goes to the New Zealand Pharmacovigilance Database within 15 calendar days of the day your New Zealand sponsor or its vendor received it, even if you disagree with the reporter about causality. Preferably by the online form with a CIOMS form (Council for International Organizations of Medical Sciences) attached; otherwise by email or file transfer. Medsafe, Adverse reaction reporting for medicines; Medicines Act 1981, section 41
Medsafe asks for serious cases from New Zealand patients only. A non-serious case, or a case from abroad, is not reported on its own; what matters from abroad arrives as a safety issue. Medsafe, Adverse reaction reporting for medicines
A significant safety issue, one that may change the benefit-risk balance and needs prompt action, is reported within 72 hours of the New Zealand sponsor’s awareness. Pharmacovigilance guideline, edition 3.0, section 6
Any other confirmed safety issue is reported within 30 days of awareness, by email or with a changed medicine notification. Pharmacovigilance guideline, edition 3.0, section 6
Sponsors have a responsibility to submit valid case reports of all serious adverse reactions to any of their medicines (including vaccines) occurring in a patient in New Zealand.
Medsafe, Adverse reaction reporting for medicines: guidance for industry
Doctors, nurses, pharmacists and patients report when they like, through the same online CARM report. In 2024 the database received 4,585 reports, 2,900 of them serious; nurses sent the most, 1,161, and the public 883. Company reports stay with Medsafe; the serious ones go on to CARM.
Chapter 3
Side by side with Europe
A small system with its own habits. Five places where it differs from the European Union (EU).
| The EU rule | The New Zealand rule | |
|---|---|---|
| Who decides | The European Commission, on the opinion of the European Medicines Agency (EMA), for centralised medicines | The Minister of Health consents to a new medicine; the Director-General to a changed one; Medsafe evaluates |
| Where a serious case goes | EudraVigilance within 15 days, wherever it happened | The national database within 15 calendar days, for patients in New Zealand only |
| A non-serious case | 90 days if it happened in the Union | Not asked for |
| A safety issue | Assessed at the EMA’s safety committee | The sponsor notifies Medsafe: 72 hours if significant, 30 days otherwise |
| Who reads the report | The national competent authority and the EMA | A university centre, CARM, under contract, with the WHO causality criteria |
Show the legal references
- Who decides: Regulation (EC) No 726/2004, Article 10(1); Medsafe, About Medsafe (consents under the Medicines Act 1981).
- Serious cases: Directive 2001/83/EC, Article 107(3); Medsafe, Adverse reaction reporting for medicines; Medicines Act 1981, section 41.
- Non-serious cases: Directive 2001/83/EC, Article 107(3); Medsafe, Adverse reaction reporting for medicines.
- Safety issues: Pharmacovigilance guideline, edition 3.0, section 6.
- Who reads: Directive 2001/83/EC, Article 102; Pharmacovigilance guideline, section 3.1.1; the CARM page.
Fewer clocks than Brussels: one for serious cases at home, two for safety issues, and a university to read what comes in.
The facts, in one place
| What it is | A business unit of the Ministry of Health; it administers the Medicines Act 1981 and the Medicines Regulations 1984. |
|---|---|
| Since | July 1998, when the Ministry’s Therapeutics Section was relaunched as Medsafe; CARM since 1965. |
| Who decides | The Minister of Health for new medicines, the Director-General for changes; the Medicines Adverse Reactions Committee advises, four times a year. Around 60 staff. |
| Seat | Wellington, 133 Molesworth Street; investigation and border control in Auckland. |
| Money | Part of the Ministry’s budget; fee-funded activities make it accountable to the industry that pays. |
| 2024 in numbers | 4,585 suspected adverse reaction reports, 1,569 of them for vaccines; 2,900 serious; nurses 1,161 and the public 883 as reporters. |
| Member of | The WHO Programme for International Drug Monitoring, a founding member in 1968; the International Coalition of Medicines Regulatory Authorities (ICMRA); the Pharmaceutical Inspection Co-operation Scheme (PIC/S) since January 2013. |
Don’t confuse it with: Pharmac
Medsafe
The regulator
- Decides: whether a medicine may be marketed, on safety, quality and efficacy
- Is: a business unit of the Ministry of Health
- Example: evaluates a new medicine for the Minister’s consent
Pharmac
The funder
- Decides: what medicines the public system pays for
- Is: a small Crown entity, separate from Medsafe, with which it has a memorandum of understanding
- Example: decides whether that consented medicine is funded
Chapter 4
Test yourself
Myth or Truth? Pick an answer to see the explanation.
“A sponsor must send Medsafe its serious overseas cases within 15 days.”
The 15-day clock covers serious cases in patients in New Zealand. What matters from abroad reaches Medsafe as a safety issue, within 72 hours or 30 days.
“Serious reports are assessed by a university centre, not by Medsafe staff.”
Medsafe contracts CARM at the University of Otago. Since October 2023 Medsafe triages the reports and forwards the fatal and serious ones to CARM’s medical assessors.
Sources (16)
- Medsafe: About Medsafe, Our Role
- Medsafe: History, Medsafe 1998 to present
- Medsafe: History, regulation under the Medicines Act 1981 until the creation of Medsafe
- Medsafe: Adverse reaction reporting for medicines, guidance for industry
- Medsafe: Guideline on the Regulation of Therapeutic Products in New Zealand, Pharmacovigilance, edition 3.0 (PDF)
- Medsafe: Adverse reaction reporting in New Zealand, 2024
- Medsafe: How to Report a Problem
- Medsafe: The Medsafe Files, Episode Six: Global Pharmacovigilance (Prescriber Update, June 2018)
- University of Otago: New Zealand Pharmacovigilance Centre and CARM
- Therapeutic Products Act 2023 (New Zealand Legislation)
- Therapeutic Products Act Repeal Act 2024 (New Zealand Legislation)
- Pharmac: What we do
- ICMRA: Membership
- PIC/S: Participating Authorities
- Directive 2001/83/EC, consolidated text (EUR-Lex)
- Regulation (EC) No 726/2004, consolidated text (EUR-Lex)
Last reviewed against these 16 sources. Every page is reviewed at least every six months.
