The Philippine Food and Drug Administration (FDA) is seeking feedback on draft guidance for its transition to new medical device rules. Read more “New medical device rules in the Philippines”
Category: International
A summary of recent TGA regulatory updates
As Australia continues to improve its regulatory framework, the Therapeutic Goods Administration (TGA) has regularly released new and updated materials concerning the regulation of both medicines and devices. A summary of the recent updates are provided below. Read more “A summary of recent TGA regulatory updates”
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to sponsors seeking authorisation to add extra information to prescription drug labels, Health Canada has released a draft guidance document detailing the agencies expectations on the use of electronic platforms to disseminate information on a prescription drug product.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”
IMDRF consultation on device regulatory reviews conducted by Conformity Assessment Bodies
The International Medical Device Regulators Forum (IMDRF) has a draft guidance document released for public consultation on the regulatory review of medical devices performed by Conformity Assessment Bodies (CABs). Read more “IMDRF consultation on device regulatory reviews conducted by Conformity Assessment Bodies”
CDSCO moves towards online SAE reporting system
India’s Central Drugs Standard Control Organisation (CDSCO) has released a notice informing sponsors that they will soon be required to file Serious Adverse Event (SAE) reports electronically via the Sugam online portal from 14 March. Read more “CDSCO moves towards online SAE reporting system”
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”
Australia’s TGA continues to revamp its medical device regulations
The Australian Therapeutic Goods Administration (TGA) has released more medical device related regulatory guidance as the agency continues to reform its medical device regulations. Read more “Australia’s TGA continues to revamp its medical device regulations”
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”
TGA’s public consultation on the repurposing of prescription medicines
The Australian Therapeutic Goods Administration (TGA) is holding a public consultation on the repurposing of prescription medicines. Read more “TGA’s public consultation on the repurposing of prescription medicines”
A summary of recent TGA guidance to industry
The Therapeutic Goods Administration (TGA) of Australia has recently released updates to numerous guidance documents for the industry. Read more “A summary of recent TGA guidance to industry”