On October 2, 2014, the European Medicines Agency (EMA) published its long-awaited policy on the publication of clinical data for medicinal products for human use (the Policy, available here). The Policy is accompanied by an extensive explanatory Q&A document, available here. This is the result of a lengthy and lively discussion among both public and private stakeholders since April 2012.
This development has been heralded as one of the most significant ones for the pharmaceutical industry to monitor, as mentioned in the Sidley Update published in February of this year (available here).
The EMA will start publishing clinical reports submitted with new marketing authorization applications and Article 58 applications filed as of January 1, 2015. As of July 1, 2015, the same rules will also apply to extension of indication applications and line extension applications relating to existing centrally authorized medicinal products. Data will become accessible only when the authorization procedure has been finalized, which means we do not expect the first data to be disclosed before mid-2016. Initially, only the publication of clinical reports is foreseen, but at a later stage the EMA also envisages the publication of individual patient data (IPD), which is the definition the EMA will use from now on, replacing the former ambiguous term ‘raw data’.
According to the definitions contained in the Policy, ‘clinical data’ means the combination of clinical reports and IPD. ‘Clinical reports’ encompass “clinical overviews (generally submitted in module 2.5) and clinical summaries (generally submitted in module 2.7) and the clinical study reports (generally submitted in module 5, “CSR”), together with appendices to the CSRs no. 16.1.1 (protocol and protocol amendments), 16.1.2 (sample case report form) and 16.1.9 (documentation of statistical methods)”.
It is important to note that the EMA will review the Policy no later than June 2016, which is expected to coincide with the applicability of the new transparency rules set by the EU Clinical Trials Regulation No 536/2014 of April 16, 2014.
We recommend that companies carefully review the Policy in conjunction with the Q&A document and assess how the information impacts them.
For more information regarding the content of this Sidley Update, please contact:
Maurits J.F. Lugard
Sidley Global Life Sciences Practice
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