Information for Industry

Guidance on the regulatory processes for suppliers in New Zealand of medicines and medical devices.

Approval Process

Date	Type	Title
15/1/2026	Notices	Updated Clinical Trial Guidelines
15/1/2026	Consultation	Outcome of the consultation on the proposed updates to the Guideline on the Regulation of Therapeutic Products in New Zealand: Clinical Trials
15/1/2026	Consultation	Proposed extension of the abbreviated procedure for new medicine applications and section 24(5)(a) notifications
7/1/2026	Notices	Notice of Medsafe Office Closure Christmas/New Year 2025/2026
23/12/2025	Committees	Medicines Classification Committee - Dates and Deadlines
23/12/2025	Committees	Minutes of the 75th meeting of the Medicines Classification Committee - 19 November 2025
23/12/2025	Committees	Medicines Classification Committee Vacancies
15/12/2025	Alert Communication	Amended legislation about medicines that can impair driving
15/12/2025	Monitoring Communication	Atomoxetine and the possible risk of gynaecomastia
8/12/2025	Consultation	Outcome on Proposed updates to the Guideline on the Regulation of Therapeutic Products in New Zealand: Bioequivalence of medicines
8/12/2025	Compliance	Exemption for advertising unapproved medicines at medical conferences
4/12/2025	Publications	Prescriber Update Vol. 46. No. 4 - December 2025
3/12/2025	Monitoring Communication	Further Update - Estradot (estradiol) transdermal patches: reports of quality and efficacy concerns

If you have a query that is not answered by the information in this section please contact us at askmedsafe@health.govt.nz