NIS Country-Specific Reports

If you have ever tried to research the regulatory requirements for non-interventional studies (NIS), you will have found that not only are there different requirements in every country but also there are different types of non-interventional study, which is turn are regulated differently.  This is what we refer to as the ‘complex simplicity of NIS’.  By design, they are simple studies but the regulatory requirements are complex. 

Our solution?  Summarise the regulatory requirements for each type of NIS in each country of interest.  This is exactly what we’ve done in our “NIS Considerations Reports” series.

The table below illustrates the NIS ‘considerations’ addressed in each report and lists the current geographical footprint.

Examples of country-specific NIS considerations covered
  • Regulatory bodies
  • Summary of the country-specific regulatory requirements for
    • Voluntary NIS
    • Mandated single country PASS
    • Mandated multi-country PASS
    • Other (e.g., research using existing data, genetic research, biobanking etc)
  • Regulatory Submissions
  • Study conduct considerations
  • Applicable legislation and guidelines
  • Useful links
Countries covered (63)
(The country list is always expanding)
Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Columbia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Kazakhstan, Latvia, Lebanon, Lithuania, Luxembourg, Macedonia, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Paraguay, Peru, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Tunisia, Turkey, UAE, UK, Ukraine, Uruguay, USA, Vietnam

Our NIS Considerations reports can be purchased directly from our online shop 

Try before you buy – Not sure if these reports will provide the information you need?  Not a problem!  Download a free report by clicking on the link…