Published: 18 March 2019
About Medsafe
History of Medicines and medical device regulation in New Zealand
Medsafe 1998 to present
Legislation
The Medicines Act 1981 and the Medicines Regulations 1984 remain in place. In 2004 the licensing of pharmacies was transferred from the Pharmaceutical Society to Medsafe (Medicines Control).
In 2002 a detailed discussion paper on a proposal for a trans-Tasman Regulatory Agency operating under new legislation was published. In 2007 negotiations between Australia and New Zealand were postponed. These negotiations were reopened in 2011, but again were unsuccessful.
Organisational structure
July 1998 the ‘Therapeutics Section’ of the Ministry of Health was launched as ‘Medsafe' with its own website. This was one of the first New Zealand Government websites.
Medsafe’s mission is to enhance the health of New Zealanders by regulating medicines and medical devices to maximise their safety and benefit.
In the early 2000’s Medsafe had three teams (49 total staff).
Business development and Support (12 staff) was responsible for policy advice, business development projects, medicine classification, pharmacovigilance, database development and publishing.
The Compliance team (18 staff) included Medicines Control (until 2003) and was responsible for medical devices, auditing and licensing, advertising, complaints and recalls and drug abuse containment.
The Evaluation team (17 staff) evaluated new and changed medicine applications and processed clinical trial applications.
The current organisational structure of Medsafe is published on the website
In 2006 Investigation and Enforcement Team in Auckland was established
Workload
In 2000/1 Medsafe received 240 new medicine applications and 1250 changed medicine applications.
Data since 2011 are published on the Medsafe website
In 2000/1 there were 57 clinical trial applications.
In October 2005 the non-interchangeable medicines list was removed from the Medsafe website.
