INOVIS  INSIGHTS

What's the news?

In 2021, the MHRA is set to join Australia, Canada, Singapore and Switzerland's existing consortium and the FDA's Project ORBIS in a collaborative effort to expedite approvals in those member states through a single approval, potentially expediting the time to approval and impacting future competitive timeline assumptions.

Key things you should know

• The Brexit decision in 2016 left the UK's MHRA with the prospect of finding itself outside of the EMA framework on departure from the EU
• The original consortium, known as ACSS was set up in 2007 included Australia-Canada-Singapore-Switzerland and was intended to speed up application reviews and approvals, through collaborative and coordinated efforts by the member states
• The MHRA's announcement to join ACSS and ORBIS in January 2021, brings with it a population the size of the prior ACSS combined, which in turn provides a further incentive for applicants who aim to secure quicker and wider market entry through a targeted application strategy
• Limitations of a consortium approach:
  • While providing a viable alternative to join approvals outside of the EMA framework, the ACSS has only reviewed a handful of applications so far
  • Project ORBIS (a similar consortium between the US FDA's Oncology Centre of Excellence with Canadian and Australian regulators, alongside newly joining UK), is limited to oncology products only, restricting the number of products that could qualify for appraisal

Great initiative, but what does this mean to existing and future competitive timelines?

Undoubtably, companies have much more choice in determining the best path forward for their own submissions and approvals. While there's no change in the case-by-case approach most companies employ, there are some key learnings from past appraisals by the ACCS and ORBIS initiatives that INOVIS applies to the strategic guidance it develops. These learnings, coupled with specialized competitive intelligence activities will provide confidence and valuable insight in shaping your competitive strategies.

All clear, but what if I have more questions than answers!

INOVIS has been a leader in competitive insight for the past 28 years and has world-leading intelligence experience that Life Science firms rely on.

 CONTACT US 

to find out how we can help you uncover timely, accurate and relevant insights to shape your competitive strategy!

& Partner, Life Sciences Group" />
PRESENTED BY
Baljit Singh, PhD
Managing Director & Partner, Life Sciences Group
   

& Life Sciences Group" />
PRESENTED BY
Harshal Kubavat, PhD
Head of Strategic Consulting, Global Pharmaceuticals & Life Sciences Group