The corporate logo of the U.S. Food and Drug Administration (FDA) is shown in Silver Spring, Maryland, November 4, 2009. U.S. health officials unveiled plans to fight avoidable injuries from medication errors or misuse, a problem that harms hundreds of thousands of people each year and can be deadly.    REUTERS/Jason Reed   (UNITED STATES HEALTH) - RTXQCTX

EMA AND FDA MARKETING AUTHORIZATIONS: CONCORDANCES AND DISCORDANCES

EMA and FDA have published in joint an article entitled “A comparison of EMA and FDA decisions for new drug marketing applications 2014-2016: concordance, discordance and why”. Most of information were sourced from EMA´s European Public Assessment Reports (EPARs) and FDA reviews. The study consisted of comparing decisions on 107 new medicine applications at the EMA and FDA between 2014 and 2016.

The result of the analysis is the EMA and FDA alignment in more than 90% of marketing authorization decisions for new medicines. The most common reasons for discordance were differences in conclusions about efficacy and differences in clinical data submitted in support of an application.

For more information: EMA/FDA analysis shows high degree of alignment in marketing application decisions between EU and US

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Call for all sponsors to publish clinical trial results in EU database

The European Commission (EC), the European Medicines Agency (EMA) and the Heads of Medicines Agencies(HMA) have co-signed a letter reminding all sponsors of clinical trials conducted in the European Union of their obligation to make summaries of results of concluded trials publicly available in the EU Clinical Trials Database (EudraCT).

Transparency and public access to clinical trial results, whether positive or negative, are fundamental for the protection and promotion of public health.

EMA has since September 2018 been identifying trials with missing results on a monthly basis and sending reminders to the sponsors of those trials to ensure compliance with the transparency rules and their follow up on their results reporting obligations.

For more information: https://www.ema.europa.eu/en/news/call-all-sponsors-publish-clinical-trial-results-eu-database