FDA has issued a new draft guideline for safety reporting which is expected to be finalised in Nov 2021. In the new edition they acknowledge that clinical trials are the main source of obtaining safety information on new products and clarify that it is responsibility of the investigators to report serious adverse events (SAEs) and protocol specific safety information. Also the new guideline set expectations SAEs to be reported immediately to IRB but no longer than 1 calendar day. The reporting timeline for medical devices is 10 days.
European medicine agency is working on a new guideline which aims to reduce animal testing as part of drug development and to replace it with cell and tissue culture testing, organoids, organ-on-chips and insilico modelling. Their far reaching goal is to replace animal testing completely in the future.
Health Research Authority (HRA) in UK has announced that as of 1 Nov 2021 the centralised radiology assurance is open for all clinical trials using ionisation radiation. The new process is expected to speed up the process of obtaining ARSAC approval.
Medicines and Healthcare products Regulatory Agency (MHRA) has updated their guidance on remote monitoring access to clarify that hospitals will need to provide access to sponsor representatives for the purpose of monitoring and that on site visits may not always be possible.
Asia and Pacific Region
Austria’s Therapeutic Goods Administration (TGA) has released new guidance to help medical device classification for devices and implants that come in direct contact with the heart, central nerve system or circulatory nervous system. Many of these devices are currently class II but as of 25 Nov 2021 they will need to be reclassified as class III.