In many ways, the strategic planning required to comply with EMA Policy 0070―a requirement to publish anonymized versions of clinical study reports (CSRs) and other submission documents―is similar to a secret agent’s mission: sponsors must keep the identities of people named or referred to in those documents top-secret while maintaining the document’s clinical utility. In … Continued
Policy 0070― published by the European Medical Agency (EMA) in October 2014― has made the world of regulatory writing a more complicated place. The policy requires specified submission documents to be made public for all marketing authorization applications (MAA’s) submitted as of 2015年1月1日 and for all indication extensions and line extensions submitted as … Continued
EMA Policy 70 requires sponsors to publish anonymized versions of clinical study reports (CSRs) and submission documents submitted in support of a marketing authorization application (MAA) after 2015年1月1日. Sponsors must prevent re-identification of people named or referred to in those documents. In March 2016, the detailed guidance document was published. This blog post … Continued
