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Global Pharma Guidance Tracker – August 2024

Global Pharma Guidance Tracker – August 2024

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Global Medtech Guidance Tracker: August 2024

Global Medtech Guidance Tracker: August 2024

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Nearly 80 documents have been posted on the tracker since its last update.

New Zealand Addresses Need For Guidance On FIH Studies & Trial Safety Monitoring

New Zealand Addresses Need For Guidance On FIH Studies & Trial Safety Monitoring

Medsafe is seeking feedback on proposals to update its clinical trials guidelines, and on two new guidance documents, one of which is dedicated to the “specific considerations” relating to the review and approval of first-in-human studies.

Global Pharma Guidance Tracker – June 2024

Global Pharma Guidance Tracker – June 2024

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Global Medtech Guidance Tracker: June 2024

Global Medtech Guidance Tracker: June 2024

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.

New Zealand Gets Cracking On NZD$604m Drug Funding Boost; Starts Repealing Landmark Law

New Zealand Gets Cracking On NZD$604m Drug Funding Boost; Starts Repealing Landmark Law

Two targeted treatments for six different types of cancer and two antifungal drugs are the first products that Pharmac has proposed should be funded after it received a boost to its budget in June. Separately, the government is seeking feedback on a bill to repeal the sweeping new therapeutic products law that was passed by its predecessor.

Global Pharma Guidance Tracker – March 2024

Global Pharma Guidance Tracker – March 2024

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

New Zealand Addresses ‘Significant’ & ‘Other’ Safety Issues In New PhV Guide

New Zealand Addresses ‘Significant’ & ‘Other’ Safety Issues In New PhV Guide

A revised pharmacovigilance guideline will come into effect in New Zealand on 1 July, although sponsors may start using it now.

Global Pharma Guidance Tracker – February 2024

Global Pharma Guidance Tracker – February 2024

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

NZ Govt Moves To Speed Drug Access Amid Plans To Wipe Out Major New Act

NZ Govt Moves To Speed Drug Access Amid Plans To Wipe Out Major New Act

A parallel assessment mechanism that will allow new medicines in any therapeutic area to be considered for funding sooner is being introduced in New Zealand, where the new coalition government is working to repeal last year’s landmark Therapeutic Products Act.