EU Regulatory Roundup: Denmark permits remote SDV during pandemic

| 30 April 2020 | By Nick Paul Taylor 

Extraordinary measures guidance from the Danish Medicines Agency (DKMA) now has been updated to allow remote source data verification (SDV) for certain clinical trials during the COVID-19 pandemic.
Remote SDV enables sponsors to verify data without sending a clinical research associate to a clinical trial site, making it an attractive option at a time when contract research organizations are reporting limited in-person access to study centers. Despite that, the first set of extraordinary measures for clinical trials during the pandemic published by DKMA did not permit remote SDV.
DKMA now says it recognizes that “onsite monitoring might be disrupted for a long period” and the disruption to monitoring could have “serious consequences for data validity.”
To update the extraordinary measures guidance and help  sponsors avoid those consequences, DKMA has collaborated with the Danish Data Protection Agency to establish temporary guidance on remote SDV. If a sponsor of an ongoing or upcoming trial needs to verify the quality of the final data, it should identify primary efficacy parameters, important safety endpoints and other data deemed critical and prepare to monitor those results remotely.
Remote SDV is limited to those critical data and to two types of clinical trials: those regarding prevention and treatment of COVID-19 and pivotal studies that are approaching completion. A sponsor must submit a substantial amendment to DKMA to adopt remote SDV.
Eligible sponsors have three options. Monitors can either can gain remote access to source data, review the data on a video conference with site staff or receive pseudo-anonymized copies of source documents. The options are subject to specific requirements, such as the need for security and the video quality to be high enough to ensure readability.  
DKMA will permit remote SDV until 1 September and will assess extending that end date in mid-August. The agency originally envisaged its extraordinary measures expiring on 17 June but extended the deadline until September in the update that added remote SDV as an option.
DKMA Guidance
Ireland’s HPRA overhauls guide to new applications and variations
Ireland’s Health Products Regulatory Authority (HPRA) has made major changes to its guide to new applications and variations to manufacturer’s authorizations. Notable changes from version 6 include the addition of three appendices about sites based in regions covered by mutual recognition agreements, the supply of unlicensed medicinal products and declarations by the qualified person. 
The appendix on mutual recognition agreements states which documents need to be shared  with production plants in countries covered by such arrangements to show compliance with good manufacturing practices. For example, companies with plants in Canada must provide evidence that their sites are compliant “with regard to the relevant category of manufacturing activity” or share an inspection exit notice issued by Health Canada.
In clarifying its position on mutual recognition agreements, HPRA updated existing parts of the guide, such as sections on contract manufacturers and laboratories. The revised guide puts the onus on applicants to confirm the operations of their contract manufacturers are within the scope of the relevant mutual recognition agreement. 
The new appendix on unlicensed or exempt medicines states companies need a wholesale distribution authorization or manufacturing and importation authorization to supply such products in Ireland. The final new appendix runs through the information that should be covered by declarations by the qualified person.
In a divergence from its normal practice, HPRA did not provide a version of the guide with the latest changes tracked on the grounds that “it would not useful due to the extent of the changes.”
HPRA Guide, More
‘Extreme pressure’ leads Swissmedic to change pharmacovigilance rules
The Swiss Agency for Therapeutic Products (Swissmedic) will reach out to healthcare professionals just once to seek additional or missing data for individual case safety reports related to pharmacovigilance  in light of the “extreme pressure” healthcare professionals are under during the COVID-19 outbreak.
Under normal circumstances, Swissmedic requires at least two follow-up requests for information if an individual case report lacks details needed to assess what happened. The requirement is intended to ensure gaps in understanding of potential adverse events are filled in, thereby leading to a fuller picture of the safety of a product.
The revised rules will remain in place until 30 June 2020.
Swissmedic Notice
Italy’s AIFA Rejects Half of Applications to Run COVID-19 Clinical Trials
The Italian Medicines Agency (AIFA) has rejected more than half of proposals it received for COVID-19 clinical trials from 17 March to 23 April, according to an agency announcement.
Potential study sponsors filed 114 submissions over that period, but only 26 of the requests received favorable responses. AIFA rejected 51 of the applications outright. The agency dismissed another 12 on the grounds that it could not assess them, either because the product being tested fell outside of its remit or the proposal lacked fundamental requirements of clinical trials. Those two groups of dismissed proposals accounted for 55% of the COVID-19 trial submissions AIFA received over the analyzed period.
Of the other 45% of application, AIFA requested changes to 13 studies, leaving a group of 26 studies that received favorable opinions. Of those studies, 11 are underway. The remaining 15 studies are being held up by paperwork or ethics committee approval.
The data provide insight into the impact of COVID-19 on the workloads of regulatory agencies. In 2018, AIFA authorized 666 filings to run clinical trials and rejected 33 applications. In a little more than a month at the height of the COVID-19 outbreak in Italy, AIFA rejected more applications to run COVID-19 trials than it did across all indications in 2018.
AIFA Statement (Italian)
France permits reprocessing of laryngoscope blades during pandemic
The French National Agency for Medicines and Health Products Safety (ANSM) has cleared hospitals to reprocess single-use laryngoscope blades to prevent supply shortages during the COVID-19 crisis.
After receiving a request for guidance on reprocessing, ANSM consulted with experts and drew up a procedure to enable safe reuse. According to the guidance, healthcare professionals must immerse the devices in a disinfectant before sterilizing them in line with the sterilization processes in place at their facilities.
The advice could improve availability of laryngoscope blades, which are used to intubate patients with respiratory failure caused by severe COVID-19. Groups including the American Society of Anesthesiologists have commented on the supply of laryngoscope blades and the potential to boost availability by cleaning and sterilizing the devices. The advice was published weeks after ANSM discussed the reuse of ventilation consumables, another set of medical devices essential to the treatment of patients suffering severe COVID-19 symptoms. 
ANSM Notice (French)
Other news:
The European Medicines Agency (EMA) has encouraged COVID-19 patients to report suspected side effects. EMA Notice


© 2022 Regulatory Affairs Professionals Society.

Tags: Europe

Discover more of what matters to you

No taxonomy