7 September 2022 - We compare and contrast the two initiatives to bring new medicines to the market faster.

Access New Active-Substance Work-Sharing Initiative (NASWSI) is an alliance of like-minded regulatory authorities, whose goal is to maximise international co-operation, reduce duplication, and increase each agency's capacity to ensure consumers have timely access to high quality, safe and effective therapeutic products.  Starting in 2018, the Access Consortium members has five members: 

• Therapeutic Goods Administation (TGA) - Australia
• Health Canada - Canada
• Health Sciences Authority - Singapore
• Swissmedic - Switzerland
• Medicines and Healthcare products Regulatory Authority (MHRA) - United Kingdom

The US FDA Oncology Center of Excellence initiated Project Orbis in May 2019 to provide a framework for concurrent submission and review of oncology products among international partners.  The US FDA together with the TGA and Health Canada took part in the first Project Orbis collaborative review.

Since then, other countries have joined and become Project Orbis Partners:

• National Health Services Agency - Brazil
• Ministry of Health - Israel
• Health Sciences Authority - Singapore
• Swissmedic - Switzerland
• Medicines and Healthcare products Regulatory Authority (MHRA) - United Kingdom

This means all members of the Access Consortium are now Project Orbis partners.

While Project Orbis is for new cancer medicines, the Access Consortium is not.  The recent TGA approval of asciminib hydrochloride (Scemblix) as part of the NASWSI is somewhat perplexing. Why was it not processed by Project Orbis? We will explore this issue further in another issue.