NMRA website update on COVID-19 pandemic
Clinical trials applications for Coronavirus (COVID-19)
The NMRA wishes to work with other international regulatory agencies to support clinical trials to develop vaccines and medicines against COVID-19. We will prioritize and provide assistance for such studies.
We have legal provisions and procedures for rapid scientific advice, reviews and approvals for clinical trials and are ready to support manufactures and researchers. Although the NMRA has not done this before, we have dedicated resources to ensure this happens. We will have greater reassurance for clinical trials that have received approvals from ‘reference’ regulatory authorities. Such applications will receive very rapid review and support.
Please submit applications directly to the NMRA helpline by emailing firstname.lastname@example.org as well as through the usual route https://enmra.nmra.gov.lk
Managing clinical trials during Coronavirus (COVID-19)
How investigators and sponsors could manage clinical trials during COVID-19
This guidance note advises those involved in clinical trials on specific issues which may arise as a result of COVID-19, and what they are required to do.
The NMRA will be as flexible and pragmatic as possible with regard to regulatory requirements for clinical trials during this time. We recognize that clinical trial resource may be significantly reduced or redeployed from research activities during this time.
The first priority should be the safety of trial participants and this will remain our focus.
• If your trial has been halted due to issues related to COVID-19, you will not normally need to inform us. The
site master file should include a note that the trial was halted and the reason.
• If a trial participant cannot attend a trial site, then delivery of IMP to a participant’s home is acceptable and
no amendment notification to the MHRA will be required. Sponsors should do a risk-assessment and should have
reasonable assurance on the integrity of the product during transit.
• Using phone calls instead of protocol-directed in-person study visits is acceptable where possible. This will not
constitute a serious breach of the protocol. A substantial amendment to update the protocol will not be required.
We would however expect that any protocol deviations are well documented internally.
• It is likely that there will be increased pressures on clinical staff during this period, so it is important to
make sure that extra burdens are not placed on investigators around scanning and uploading many documents.
• The use of alternative means of oversight such as teleconferences / videoconferences is encouraged.
More details can be seen at NMRA website