Brazil’s Anvisa Updates medical device regulations during COVID-19 pandemic.
Anvisa’s updated regulation RDC 379/2020 provides requirements for medical device manufactures and identifies devices eligible for priority importation.
EMA FAST TRACKS FOR MEDICINES AND VACCINES DURING COVID-19 PANDEMIC
On May 4, 2020, The European Medicines Agency (EMA) details the rapid approval procedures for COVID-19 products which includes scientific advice, rolling reviews, accelerated assessments.
Argentina’s ANMAT Requirements for Facemask Registration
Argentina’s ANMAT releases requirements for Facemaks to act as a protective barrier against Coronavirus and be elgibile for regirstration.
Mexico’s Cofepris releases provision for ventilator requirements during COVID-19 Pandemic.
On April 6, 2020 Mexico’s Cofepris released provisions on the minimum requirements for ventilators to receive approval during the COVID-19 pandemic.
The EU releases updated guidance on conducting clinical trials during COVID-19 Pandemic.
On April 27, 2020 The European Medicines Agency (EMA) released the Guidance on managing clinical trials during the coronavirus disease (COVID-19) pandemic, the European Commission added advice on distribution, data verification and communicating with authorities.
Brazil’s Anvisa Releases New Technical Note on the conduct of clinical trials during the COVID-19 pandemic.
Brazil’s Anvisa issues technical note that gathers the latest guidelines on the conduct of clinical trials in the face of the new coronavirus pandemic.
EU Changes IVDR Plan due to COVID-19
The European Union’s new In Vitro Diagnostic Regulations (EU IVDR 2017/746) action is delayed due to COVID-19.
The Office of Human Research Protection Issues Guidance on the Conduct of Clinical trials During COVID-19
On April 8, 2020 the USA’s Office of Human Research Protections (OHRP) released a guidance on Human Subject Protection Regulations included under regulation 45 CRF part 46, which applies to COVID-19 response.
How to make a Home-Made Face Mask: Health Authorities Recommendations
Learn how to make a home-made face mask based on health authority recommendations around the world.
The FDA Ventilator Requirements for EUA
To face the increase demand of ventilators and other respiratory devices in USA due to the COVID-19 pandemic, US FDA released a new guidance on the FDA expedite review of new ventilator under the Emergency Use Authorization (EUA) program.
Japan’s MHLW Allows Online IRB Meetings for Coronavirus Trials
Japan’s MHLW issued on April 1, allowing institutional review board (IRB) meetings to be held online or via emails when urgent deliberations are needed to decide whether to approve clinical trials for COVID-19.
The FDA Introduces the Coronavirus Treatment Acceleration Program (CTAP)
The FDA introduces the Coronavirus Treatment Acceleration Program (CTAP) to expedite the development of safe and effective life saving treatments against Coronavirus.