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Australian Regulator On The Highs & Lows Of Project Orbis

 
• By Ian Schofield

The US FDA-led initiative for collaborative submission and review of new cancer drugs has produced a number of benefits since it was introduced in 2019, including more “robust” regulatory decisions and earlier market access, the DIA Europe 2022 conference heard. 

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Project Orbis uses concurrent reviews to speed new cancer drugs to market • Source: Shutterstock

The Project Orbis collaborative oncology drug review program has “exceeded our expectations” in terms of encouraging earlier regulatory submissions in Australia, although some challenges remain with regard to issues such as review processes, resources and choice of submission pathway, says a senior official at the country’s Therapeutic Goods Administration.

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More from International

Global Pharma Guidance Tracker March 2025

 
• By Vibha Sharma and Anabel Costa-Ferreira

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.

Industry Benefits As EU CTIS Hits Global Data Sharing Milestone

 
• By Neena Brizmohun

The EU Clinical Trials Information System has achieved primary registry designation in the International Clinical Trials Registry Platform in a move that is expected to reduce regulatory burden for companies and help them lower compliance costs by aligning with publication requirements in medical journals.

Gene Therapy ‘Survival Of The Fittest’ – Why Companies Need To Understand Health Systems

 
• By Eliza Slawther

Cell and gene therapy manufacturers must consider the practicalities of their product within the context of a health care system before it comes onto the market to be successful, experts from Novartis, AstraZeneca and England’s National Health Service say.

Global Pilot Reduces Drug Manufacturing Inspections With Hybrid Approach

 
• By Vibha Sharma

A global collaborative inspections pilot reduced the number of individual inspections for participating manufacturing facilities, demonstrating that multiple regulatory authorities can carry out joint inspections using a mix of on-site and remote approaches.

More from Geography

US FDA User Fee Collection Safe In Preliminary Trump 2026 Budget Plan

 
• By Cathy Kelly

The preliminary White House 2026 budget plan cuts agency funding, but not so sharply that user fees are excluded from collection.

Beyond Tariffs: The Silver Lining Of The US Pharma Security Investigation

 
• By Jessica Merrill

An investigation by the US Secretary of Commerce into pharmaceutical imports gives industry an opportunity to comment. AAM CEO John Murphy talked to Pink Sheet's sister publication Scrip about the latest developments.

New EU Approvals

 
• By Neena Brizmohun

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include four new products, one of which is Tivdak, Pfizer/Genmab’s treatment for previously treated recurrent or metastatic cervical cancer.