New Swiss Clinical Trial Framework Takes Effect With Updated Reporting Rules

Transitional provisions have been put in place to ensure the smooth implementation of new trial rules and requirements in Switzerland.

Clinical trial on computer screen
Switzerland has updated its clinical trials framework (Shutterstock)

Four new ordinances intended to improve the Swiss clinical trials regulatory framework have now taken effect, with updated trial reporting rules, greater protection for study participants, and clearer definitions of certain terms.

More from Clinical Trials

E6(R3) Introduces Flexibility And Challenges To Clinical Trial Documentation

 
• By 

The new global GCP guideline, ICH E6(R3), enables researchers and clinical trial administrators to tailor their documentation processes, but also opens the door for more scrutiny during GCP inspections.

EMA’s Newly Qualified AI Tool To Boost MASH Market Dynamics

 

The European Medicines Agency’s qualification of the AIM-NASH tool is said to signify a major advancement for clinical trials for metabolic dysfunction-associated steatohepatitis. The market size for MASH treatments is expected to grow substantially in the coming years.

Combating Bioequivalence Data Fraud: Indian CROs Face Mandatory Registration

 

As Indian CROs are bracing for new registration mandates, an expert panel at the IGBA’s 3rd Bioequivalence conference discusses the implications of non-compliance in bioequivalence studies.

Elevar/Hengrui’s Second US CRL A Bad Omen For Multiregional Trials In Asia-Dominant Cancers?

 

While CMC glitches linger over a US NDA for Elevar/Hengrui’s novel liver cancer combination following a second complete response letter, the separate issue of underrepresentation of US patients in multiregional trials is looming large after new FDA draft guidance last year.

More from Europe

EMA’s Newly Qualified AI Tool To Boost MASH Market Dynamics

 

The European Medicines Agency’s qualification of the AIM-NASH tool is said to signify a major advancement for clinical trials for metabolic dysfunction-associated steatohepatitis. The market size for MASH treatments is expected to grow substantially in the coming years.

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

 

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.

EMA Considers Whether Intrathecal Zolgensma Deserves Fast Tracking

 

Novartis is planning to file EU and US marketing applications for an intrathecal formulation of its spinal muscular atrophy gene therapy, Zolgensma, in H1 2025.