Revised: 15 January 2026
Information for Industry
Current Guidelines on the Regulation of Therapeutic Products in New Zealand
Overview of therapeutic product regulation
- Overview of therapeutic product regulation. (PDF 344 KB, 22 pages)
Regulatory requirements for medicines and related products
- Overview of regulatory processes for new and changed medicines. (PDF 313 KB, 13 pages)
- New medicine application (PDF 2 MB, 66 Pages)
- New and changed related products (PDF 333 KB, 12 pages)
- Ingredients in new medicines and related products (PDF 314 KB, 7 pages)
- Changed medicine notifications and non-notifiable changes (PDF 297 KB, 18 pages))
Information for prescribers and consumers
- Requirements for information for prescribers and consumers (PDF 198 KB 16 pages)
- Data sheet template explanatory guide (PDF 423 KB, 26 pages)
- Data sheet template (Word 37 KB, 2 pages)
Pharmacovigilance
- Pharmacovigilance Edition 3.0 (PDF, 521 KB, 36 pages)
(effective from 1 July 2024)
Clinical Trials
- Regulatory approval and good clinical practice requirements
- Current UNTIL 1 July 2026 (PDF 273 KB, 26 pages
- Current FROM 1 July 2026 (PDF 530 KB, 33 pages) - you may use these guidelines from 15 January 2026.
- Clinical Trial Safety Monitoring and Reporting (PDF 345 KB, 14 pages)
- Considerations for first-in-human (FIH) and early phase clinical trials (PDF 256 KB, 6 pages)
- Clinical Trial Site Notification Form (PDF 76 KB, 2 pages)
- Investigator CV template (Word, 56 KB, 1 page)
