Published: 1 September 2016

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The Medsafe Files — Episode One: What is Medsafe?

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Prescriber Update 37(3): 34
September 2016

Responses to consultations and enquiries to Medsafe demonstrate that our role is not always fully understood. Additionally, new legislation is on the way and it is important for you to understand our role so you can contribute to consultation. Welcome to our new series of articles 'The Medsafe Files'.

Medicines legislation is in place to manage the risks of avoidable harm associated with the use of therapeutic products. Medsafe is the New Zealand Medicines and Medical Devices Safety Authority and, with some exceptions such as pharmacy licensing, is responsible for administering the Medicines Act 1981 and Medicines Regulations 1984.

The role of Medsafe as the regulator is to administer the New Zealand legislation to help industry and healthcare professionals comply with the law. The aim is to maintain a favourable balance between the benefits and risks of harm of using a therapeutic product in the intended treatment population. We undertake activities such as the pre-marketing approval process of medicines and post-marketing surveillance of medicines and medical devices to manage the risks associated with the use of medicines and medical devices.

Medsafe regulates products that are used for a therapeutic purpose including medicines, related products, medical devices and controlled drugs used as medicines. Definitions for these product types can be found on the Medsafe website (www.medsafe.govt.nz/other/about.asp#do).

Medsafe is accountable to the Ministry of Health and, through the Ministry, to the Minister of Health. Medsafe is largely funded by fees collected from the therapeutics industry. Medsafe is small by international standards, with 56 full-time equivalents based in both Auckland and Wellington. In comparison, the Therapeutic Goods Administration, the equivalent organisation in Australia, employs around 750 staff.

Medsafe is not involved in funding medicines; this is the responsibility of PHARMAC (www.pharmac.govt.nz/). Medsafe does not regulate healthcare professional practice and Medsafe cannot provide medical advice about an individual's medical condition. We encourage consumers to talk to their healthcare professional if they have concerns about a medicine they are taking.

Upcoming episodes of The Medsafe Files include the following:

• clinical trials
• pre-market approval
• devices
• pharmacovigilance
• border control
• good manufacturing practice
• classification.

See www.medsafe.govt.nz/other/about.asp for more information about Medsafe.

The Medicines Act 1981 and the Medicines Regulations 1984 can be found at www.legislation.govt.nz