AstraZeneca's commitment to Clinical Trial Transparency continues through its speedy adoption to the new European Medicines Agency (EMA) policies as a business priority. EMA Policy 0070 requires all Clinical Study Reports (CSRs) and associated Overview Documents used in the submission for approval of products in the European Union be posted publicly. These documents have Personal Protected Data (PPD) masked as well as very limited Commercially Confidential Information (CCI) redacted. For more details on EMA policy 0070, please refer to the EMA publication of the policy . AstraZeneca has been delivering on this new policy since 2016.
In compliance with EMA Policy 0070 public access to the following Redacted Clinical Packages are available on the new EMA Clinical data website.As new packages for AstraZeneca products become available, this list will be updated.
|1- ZURAMPIC®||Zurampic (Lesinurad) co-published with Grunenthal EMA Policy 0070 Clinical Document Package|
|2- TAGRISSO®||Tagrisso EMA Policy 0070 Clinical Document Package|
|3- Zaviceft||Zaviceft co-published with Pfizer EMA Policy 0070 Clinical Document Package|
|4- Pandemic||Pandemic EMA Policy 0070 Clinical Document Package|
|5- Qtern||Qtern EMA Policy 0070 Clinical Document Package|