EMA Looks For Efficiencies For Companies Ahead Of Relaunching Clinical Data Transparency Policy
Based on its learnings from proactively publishing clinical trial data on COVID-19 products, the European Medicines Agency is making procedural changes to its clinical data publication policy that is set to resume after being temporarily suspended in 2018.
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The European Medicines Agency has issued revised guidance on its Clinical Data Publication policy to help companies navigate procedural changes that will be introduced when the publication of clinical trial data on non-COVID-19 products is partially resumed under the policy from September 2023.
The European Medicines Agency is preparing to resume proactively publishing clinical trial data submitted by companies to support their marketing authorization applications for non-COVID-19 products.
An expert in transparency explained what drug sponsors can do to support their compliance staff in identifying commercially confidential information in accordance with the clinical trial transparency initiatives of Health Canada and the European Medicines Agency.