Health Canada’s guidance on electronic media in prescription drug labelling

In response to sponsors seeking authorisation to add extra information to prescription drug labels, Health Canada has released a draft guidance document detailing the agencies expectations on the use of electronic platforms to disseminate information on a prescription drug product. Read more “Health Canada’s guidance on electronic media in prescription drug labelling”

ACCESS Consortium guidance on updating authorised coronavirus vaccines in the wake of virus mutations

The regulatory approval of COVID-19 vaccines towards the end of 2020 and start of 2021 coincided with the detection of new SARS-CoV2 strains in the UK, South Africa and Brazil. The ACCESS consortium has released a document detailing the regulatory approach for updating authorised coronavirus vaccines to target new strains. Read more “ACCESS Consortium guidance on updating authorised coronavirus vaccines in the wake of virus mutations”

IMDRF publishes finalised document on IVD device classification

The International Medical Device Regulators Forum (IMDRF) has published a document on the classification of in vitro diagnostic (IVD) medical devices. It has been created with the aim of harmonising the classification of IVD devices in order to ensure a globally consistent approach to premarket approval. Read more “IMDRF publishes finalised document on IVD device classification”