Canada’s Minister of Health Patricia Hajdu ordered an extension last week giving Health Canada an additional 15 days to review clinical trial applications for therapies not related to SARS-CoV-2, the virus behind COVID-19, through November 16, 2020. This...
Regulatory
Category
China’s Regulatory Authority Updates Preservation of Essential Documents Guidance for Clinical Trials & More
The National Institute of Allergy and Infectious Disease (NIAID) ClinRegs represents a compelling free service aggregating clinical research regulations from around the globe. With frequent updates as they are relevant and available, most recently the China profile...
New COVID-19 Dedicated Yellow Card Reporting Site in the UK for Reporting Adverse Events
The national regulatory agency for the United Kingdom—the Medicines and Healthcare products Regulatory Agency (MHRA)—recently launched a “Yellow Card” service for SARS-CoV-2, the virus behind the COVID-19 pandemic. This website has been established for the reporting...
Top Law Firm’s Italian Clinical Trial Specialists Discuss Challenges & New Opportunities Conducting Clinical Trials in Italy During COVID-19
The EU Commission, the European Medicines Agency (EMA), and the Heads of Medicines Agency (HMA) published new guidelines on April 28, 2020 on the management of clinical trials during the COVID-19 pandemic. Serving as a set of harmonized recommendations across the EU,...
European Medicines Agency Seeks ‘Harmonized Approach’ to Clinical Trials Addressing COVID-19 in the EU
Has European research into a COVID-19 treatment been too fragmented? Apparently, the European Medicines Committee (CHMP or EMA) thinks so based on a recent statement meant for investigation there. The overarching regulatory authority now promotes a “harmonized...
Gates Foundation Sponsors Symposium on China’s Change to Drug Laws and Reform
The Bill and Melinda Gates Foundation organized a symposium December 18 in Beijing, China, to discuss pharmaceutical innovation, including the recently revised drug administration law in that country. Changes to China’s Drug Administration Laws At the symposium...
University of Virginia Leads Statewide Collaboration Effort to Broaden Access to Medical Research Data
The National Science Foundation will award $2.5 million into the University of Virginia to form the Virginia Assuring Controls Research Data (ACCORD), a collaborative effort of the University of Virginia (UVA) and University of Virginia’s College at Wise, leading a...
ClinRegs Updates their Thailand Profile for Clinical Trials Regulatory Intelligence
The Thailand Profile in ClinRegs has been reviewed and updated to reflect current requirements. Key updates are included below. ClinRegs is a TrialSite News favorite. The Following Updates Occurred in ClinRegs: Revised 2018 version of Notification of the Food and Drug...