EMA Reasons for Rejection of CCI

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New data from European Medicines Agency (EMA) confirms the tough position EMA is taking in regard to commercially confidential information (CCI). According to the European Medicines Agency’s “EMA Update on Clinical Data Publication” published on 29 January, 2018, 76% of CCI instances were rejected in 2017. Interestingly, the EMA has provided further insight on how they are considering CCI by citing five reasons for rejection.

EMA reasons for rejection of CCI

EMA Reasons for Rejection of CCI

1. In the public domain

Information is not confidential when already in the public domain or publicly available. Some examples of this include publication on company websites, scientific guidelines, clinical trial registries, scientific literature, and patent applications.

2. No innovative feature

Information that does not bear any innovative features is not considered CCI.

3. Public interest

This reason for rejection pertains to the following types of information that, in the Agency’s view, do not constitute CCI:

  • General or administrative information: names of all CROs and vendors in trial-related duties and functions
  • Some/certain quality related information: temperature, humidity, parameters and storage duration as applied in stability tests
  • Non-Clinical related information: quantification range (lower and upper quantification limits) of pharmacokinetic and pharmacology tests/methods; information concerning a generally-0used/well-known immunohistochemistry method
  • Clinical related information: statistical methods (including imputation methods used for missing data); protocol and protocol amendments.

4. Insufficient justification

If the Agency considers the justification insufficient, then additional clarifications are requested in a justification table. This includes justifications that the Agency finds too vague or not sufficiently specific.

5. Irrelevant justification

If the Agency considers the justification irrelevant, then additional clarifications are requested in a justification table.

 

The most common EMA reasons for rejection of CCI included ‘insufficient justification,’ which was at least one reason sited on 63% of all instances rejected. This was closely followed by ‘in the public domain,’ which was at least one reason on 50% of all instances rejected.

At Synchrogenix, we are more than just a Transparency vendor. We leverage our expertise in regulatory strategy, intelligence, and policy to guide our sponsors through the CCI process saving them time and costs. Synchrogenix ensure a smooth consultation process between the sponsor and EMA whilst outputs are finalised for public consumption. This is by providing insight to the source reports as early as possible in the process. Synchrogenix is a regulatory and communications strategy, science and solutions company that works through the entire regulatory continuum and across all functional areas.  Therefore, from a writing perspective, we are able to deploy strategies in our report writing with transparency in mind. We consider how we’re authoring the original documents we’re submitting to the EMA in regard to CCI in order to minimize the downstream impact to transparency .

Contact us today at contactus@synchrogenix.com to learn more.

Synchrogenix Regulatory & Communications Strategy, Science & Solutions: snapshot

 

Visit this link for more information on the  EMA’s Guidance to Pharmaceutical Industry on Redacting Commercially Confidential Information (CCI) in Clinical Reports & Process.

Author: Synchrogenix

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