Revised: 8 May 2023
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 331 KB, 24 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)
- Appendix 8: Data requirements for new medicine applications (PDF 423 KB, 29 pages)
- Ingredients in new medicines and related products (PDF 314 KB, 7 pages)
- Changed medicine notifications and non-notifiable changes (PDF 407 KB, 17 pages))
Regulatory requirements for medical devices
- Regulatory requirements for medical devices. (Under construction please refer to the guidance for medical devices for current guidance)
Pharmacovigilance
- Pharmacovigilance Edition 2.2 (PDF 424 KB, 35 pages)
- Summary of Changes made to Pharmacovigilance Edition 2.2 (PDF 108 KB, 3 pages)
Safety alerts, complainta and recalls
- Therapeutic product safety alerts, complaints and recalls. (Under construction please refer to the uniform recall procedure (PDF 469 KB, 49 pages))
Information for prescribers and consumers
- Requirements for information for prescribers and consumers (PDF 268 KB 13 pages)
- Summary of Changes made to: Requirements for information for prescribers and consumers (PDF 90 KB, 3 pages)
- Data sheet template explanatory guide (PDF 241 KB, 25 pages)
- Data sheet template (Word 18 KB, 1 page)
Clinical Trials
- Regulatory approval and good clinical practice requirements (PDF 273 KB, 26 pages)
- Clinical Trial Site Notification Form (PDF 76 KB, 2 pages)
