April 2020: Comparing Guidances on COVID-19 Disruptions of International Clinical Trials

On April 08, 2020, Ropes & Gray published a document comparing the guidance documents related to COVID-19, its impact on and additional requirements for conducting the clinical trials. The guidance documents involved are issued by the European Medicines Agency (“EMA”), the French National Agency for Medicines and Health Products Safety (“ANSM”), the German Federal Ministry of Health (“BfArM”), the Italian Medicines Agency (“AIFA”), the Spanish Agency for Medicines and Health Products (“AEMPS”)Switzerland’s Swissmedic and swissethics, the Australian Department of Health, the Brazilian Health Regulatory Agency (“ANVISA”)Health Canada, and Singapore Health Sciences Authority (“HSA”).

Earlier, on April 02, 2020, a comparative chart was published summarizing the guidance documents issued by FDA, EMA, MHRA and PMDA.

The comparisons include initiating a new clinical trial, continuing a clinical trial, any changes (amendments) to a clinical trial, informed consent changes, study visits, COVID-19 screening procedures, monitoring
activities, investigational product distribution and study reporting.

May 2018: Australia New Zealand Regulatory Update

New import function for Clinicaltrials.gov records

  • Currently, all trials registered on ClinicalTrials.gov with a recruitment site in Australia and/or New Zealand are automatically imported and displayed on the ANZCTR website. From 20th May, registrants will be able to add additional ANZCTR specific information and local contact details to these records if they wish, without the need to apply for an ANZCTR registration number (ACTRN) as well.
  • Data imported from ClinicalTrials.gov record will not be editable. The additional ANZCTR information that can be provided includes: Accrual to date, Australian recruitment details (hospitals, postcodes), funding source, primary and secondary sponsor, other collaborators, ethics approval committees and dates, Principal Investigator details, public and scientific contact details, and brief summary (if no data provided on ClinicalTrials.gov record). All these additional details are displayed in a separate marked section at the bottom of the trial record.

Original article is available here.