How Does The ACCESS Consortium Compare To Project Orbis?

In the second of a two-part interview with the Pink Sheet, an expert from the Swiss drug regulator discusses the similarities and differences between the ACCESS Consortium and Project Orbis, while the Canadian regulator also offers its perspective.

Pathways
ACCESS And Orbis Are Two Different Regulatory Pathways • Source: Shutterstock

Switzerland and Canada are among the five international medicines regulators involved in the ACCESS Consortium and Project Orbis, two separate coalitions that were established with the goal of speeding up and harmonizing the regulatory review processes at international level.

There are some key differences between Project Orbis and the ACCESS Consortium. The biggest is that Project Orbis is directed...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Europe

Lilly Wins EU Thumbs Up For Kisunla After EMA Reverses Rejection

 

The European Medicines Agency says that Eli Lilly's Alzheimer's disease drug should be approved for use in the EU, now that it has re-examined the negative opinion it previously adopted.

EMA Says ‘No’ To Roche/Sarepta’s DMD Gene Therapy Elevidys

 

The European Medicines Agency has recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy, despite the product securing approvals in the US and other markets.

EU’s Life Sciences Strategy Faces Race Against Time, Says Clinical Trials Community

 
• By 

The report gave examples of missed opportunities for innovation and patient access, as well as regulatory and operational problems that undermine the conduct of timely clinical trials in Europe.

US Tariffs And The EU’s Critical Medicines Act: Lessons On Nearshoring And CMO Diversification

 

Nearshoring production and diversifying contract manufacturing networks can help companies stave off cost increases that will be reflected in higher medicine prices.

More from Geography

US FDA Cancer Reviewers Heading For The Exits, Potentially Impacting Review Timelines

 

US FDA's cancer drugs division is feeling the effect of drug reviewer departures, despite efforts to keep them at the agency.

Australia Targets Clinical Trial Reform, AI Use And Drug Shortages In 12-Month Plan

 

Reforming clinical trial regulations, addressing the use of artificial intelligence, mitigating medicines shortages and strengthening ties with other drug regulators are key priorities for Australia’s Therapeutic Goods Administration over the next year.

EU’s Life Sciences Strategy Faces Race Against Time, Says Clinical Trials Community

 
• By 

The report gave examples of missed opportunities for innovation and patient access, as well as regulatory and operational problems that undermine the conduct of timely clinical trials in Europe.