The New Zealand Government is working on a new and comprehensive regulatory regime to regulate therapeutic products in New Zealand, which will replace the Medicines Act 1981 and its Regulations.
The Ministry of Health released a draft of the Therapeutic Products Bill and Consultation Document for public consultation. Consultation closed in April 2019. Find out more about the consultation.
Therapeutic product is an umbrella term for products that are intended to be used in or on human beings for a therapeutic purpose. Examples of therapeutic purposes include bringing about a physiological response to prevent, diagnose, monitor, alleviate, treat, or cure a disease, ailment, defect, or injury.
Therapeutic products can present serious risks of harm, especially if used inappropriately. Assuring that the benefits of therapeutic products outweigh possible risks of harm to consumers is fundamental to the delivery of high quality health and disability support services.
The Government is currently developing a new therapeutic products regulatory regime. This follows the cessation of the Australia New Zealand Therapeutic Products Agency (ANZTPA) project.
As well as replacing and modernising the regulatory arrangements for medicines, the regime will provide regulation of all therapeutic products. This includes medical devices and cell and tissue therapies which are currently not fully regulated in New Zealand.
The new regime will be flexible enough to ensure effective control over the quickly evolving technology used in therapeutic products, while also being as efficient and cost-effective as possible.
The new regime will also look to align with international standards where appropriate, and uphold the quality of regulation currently carried out by the Ministry of Health. This will help to:
- assure the safety of products used in health care delivery in New Zealand
- secure New Zealand producers a positive position in the global market place.
The Government has made a series of decisions about the new regulatory regime that are being made publicly available through the below documents.
Released 14 December 2018
- Cabinet paper: Therapeutic Products Regulatory Scheme: Overview and Consultation on Bill Exposure Draft (PDF, 191 KB) – this paper has been redacted consistent with the Official Information Act 1982
- Cabinet minute: Therapeutic Products Regulatory Scheme: Overview and Consultation on Bill Exposure Draft (PDF, 128 KB)
- Regulatory impact statement: Therapeutic Products Bill – Personal Import of Medicine by mail/courier (PDF, 56 KB), (Word, 40 KB)
Minutes from November 2015 and March 2016 Cabinet papers
- Cabinet minute: Therapeutic Products Regulation Paper 1: Context and Overview (PDF, 144 KB)
- Cabinet minute: Therapeutic Products Regulation Paper 2: Proposals for a Therapeutic Products Bill (PDF, 141 KB)
- Cabinet minute: Therapeutic Products Regulation: Further Policy Approvals (PDF, 150 KB)
Released 28 April 2016
Papers and regulatory impact statements considered by Cabinet in November 2015 and in March 2016. The decisions set the direction for the new regulatory regime and were used as the basis for the drafting of the new legislation.
- Therapeutic Products Regulation Paper 1: Context and Overview (Word, 35 KB)
- Therapeutic Products Regulation Paper 2: Proposals for a Therapeutic Products Bill (Word, 157 KB)
- Regulatory Impact Statement 1 (for Cabinet Papers 1 and 2) (Word, 130 KB)
- Therapeutic Products Regulation Paper 3: Further Policy Approvals (Word, 46 KB)
- Appendix 1 for Cabinet Paper 3: A3 (PowerPoint, 68 KB)
- Regulatory Impact Statement 2 (for Cabinet Paper 3) (Word, 114 KB)
The papers set out the Government’s intention that the new regulatory regime cover all therapeutic products and has controls that assess and manage the risks, which will vary between products. The Government is seeking a high-quality regime that is efficient and sustainable, positions New Zealand well on the international stage and is designed so that it can be kept up-to-date easily.