medicines-medical devices-medtech-regulatory affairs
medicines-medical devices-medtech-regulatory affairs
1 July Global regulators agree on key principles on adapting vaccines to tackle virus variants On 30 June, regulators from around the world discussed emerging evidence to support adaptation of COVID-19 vaccines as the SARS-COV-2 virus continues to evolve during…
The table below shows the COVID-19 vaccines and treatments regulatory status at a glance. It is updated on an ad hoc basis. Regulatory status from 14 April 2022 is covered. On mobile, the table is best viewed by scrolling sideways.…
The table below shows the COVID-19 vaccines and treatments regulatory status at a glance. It is updated on an ad hoc basis. Regulatory status from 24 September 2021 – 13 April 2022 is covered. On mobile, the table is best viewed by scrolling sideways.…
Last updated: 21 December 2021 The European Commission (EC) has established a portfolio of the ten most promising treatments for COVID-19. A group of independent scientific experts has screened 82 therapeutic candidates in late stage clinical development and identified 10 candidates as…
The table below shows the COVID-19 vaccines and treatments regulatory status at a glance. It is updated on an ad hoc basis. Regulatory status from 8 May 2020 – 23 September 2021 is covered. On mobile, the table is best…
A new, sensitive COVID-19 test produces sample-to-signal in under ten minutes. Researchers from the University of Birmingham have confirmed the speed, accuracy and simplicity of a novel, highly sensitive testing method for COVID-19 that can be deployed at entertainment venues,…
An Artificial Intelligence (AI) powered device able to detect SARS-CoV-2 (the virus that causes COVID-19) within 20 seconds is currently under UK MHRA assessment. What is the test called? The device is called SpectraLIT. Who has developed this test? The SpectraLIT device…
The EU Strategy on COVID-19 Therapeutics delivered an announcement from the EU commission on the first portfolio of five therapeutics that could soon be available to treat patients across the EU. Monoclonal antibodies The four newly developed monoclonal antibodies under…
Roche has been granted a CE mark for its SARS-CoV-2 Antigen Self Test Nasal for rapid at-home testing. About the SARS-CoV-2 Antigen Self Test Nasal The test enables individuals to quickly and conveniently test themselves for COVID-19 at home using a simple…
Breathonix, a startup from the National University of Singapore (NUS) has received local approval for its rapid breath test for COVID-19. The test is designed to detect Covid-19 and provide accurate results within one minute. The BreFence Go COVID-19 breath…