Policy EMA/0070 – part 3
Commercially Confidential Information (I)
The cycle of posts dedicated to Clinical Trial Transparency continues with the description and the comment Help EA (European Accreditation) on the identification and modification of confidential business information (CCI) in clinical trials, consistent with the wording of the Policy EMA 0070.
On August 20, 2015, EMA published the External guidance on the identification and redaction of commercially confidential information (CCI) in clinical reports submitted to the EMA for the purpose of publication in accordance with EMA Policy 0070. The key contents of these guidelines were anticipated during the June 24th EMA webinar concerning the various aspects of the Agency Policy 0070.
The guidance is a working tool and a reference document for the pharmaceutical companies. It aims to support them for the preparation of their justifications regarding commercially confidential information (CCI) in documents that fall under the scope of the Policy 0070.
Although most of the clinical information contained in clinical reports should not be considered CCI, EMA acknowledges that in limited circumstances, they may contain CCI, and could, therefore, be subject to redaction prior to publication. Whenever the Applicant/Marketing Authorisation Holder (MAH) proposes the redaction of CCI, consultation will be undertaken. EMA will scrutinise the justification for the redaction of CCI in order to assess whether the definition of CCI applies. Consequently, Annex 3 “Redaction principles” to Policy 0070 identifies certain types of information that can potentially be considered CCI.
Purposes of the Guidance
This guidance will enable the public to obtain a better understanding of the level and nature of redactions that are typically accepted within the published documents as well as a comprehensive overview on how the redaction of CCI is handled within the context of Policy 0070. The guidance will focus on:
- how to identify and flag/highlight in the clinical reports pieces of text (proposed redactions) that may potentially constitute CCI;
- the minimum level of detail expected in the justification that will allow the EMA to perform an adequate and informed evaluation of the proposed redactions;
- establishing a better-defined approach of the identification of CCI when applying the redaction principles laid out in Policy 0070
The guidance aims to ensure a common understanding of what can or cannot be considered CCI within clinical reports and to increase consistency in the proposed and accepted redactions across the range of clinical reports relating to various human medicinal products and regulatory procedures. Also, it aims to ensure a good quality of the justifications for the proposed redactions, thereby reducing the administrative burden for all parties involved in the preparation and publication of the documents falling under Policy 0070.
Points to consider for the preparation of the redaction proposal of a clinical report
CCI shall mean any information contained in the clinical reports submitted to the EMA by the Applicant/MAH which is not in the public domain or publicly available and where disclosure may undermine the legitimate economic interest of the Applicant/MAH.
Prior to proposing any redactions, the Applicant/MAH should be aware of the level of information already available in the public domain concerning their product’s development (e.g. study design and results), scientific knowledge and advancements within the relevant therapeutic area(s). Such preparatory work by the Applicant/MAH is essential and will enable for an expedited consultation process, thereby reducing the number of instances in which the EMA will have to reject proposed redactions because the information is already in the public domain.
– To be continued –