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CCI/CBI: How to Identify Confidential Information in Regulatory Submissions for Investigational Drugs

Outside of protecting study participants’ personal information (PI) within clinical research publications, pharmaceutical organizations should avoid disclosing company-related secrets and procedures which could aid their competitors in gaining market advantage. This type of information is called Commercially Confidential Information (CCI) by the European Medicines Agency (EMA) or Confidential Business Information (CBI) by Health Canada (HC).

What is CCI/CBI?

CCI – Any information contained in the clinical reports submitted by the applicant/MAH [marketing authorisation holder] which is not in the public domain or publicly available and where disclosure may undermine the legitimate economic interest of the applicant/MAH. (EMA)
CBI – Information that has actual or potential economic value because it is not publicly available, and its disclosure would result in a material financial loss to the person/business or a material financial gain to their competitors. (HC)

Essentially, CCI/CBI is information that could be used by your competitors to advance their products to outcompete yours within the market. This is information that is not yet available to the public such as projects in progress, unpublished data, brainstorming notes, or plans for future studies. It could also include internal documentation for operational processes such as details about product synthesis, modified quantitative analysis methods used exclusively by the researchers, or novel developments on products or intellectual property. In short, it’s any information known to the researching organization, but not known by the public, which if given to the wrong hands, could result in financial loss for the company.

What isn’t protected by CCI/CBI?

The easy way out for pharmaceutical companies is to redact everything in a regulatory submission that could relate to company-specific information. That’s why the EMA and Health Canada have created a set of guidelines specifically targeting common items which do NOT fall under the definition of CCI/CBI. The primary and most important indicator that information is not CCI/CBI is that it’s available in the public domain. This may include, but should certainly not be limited to the following locations:

  • Company Website
  • Clinical Trial Registries
  • Scientific Literature
  • Scientific Guidelines
  • Regulatory Authorities’ websites
  • Patent Application documents

Most information published in clinical research should, by definition, be of clinical nature. However, there may also be additional filler information which falls under administrative, quality-related, or non-clinical information. These sections may look like CCI/CBI to the authors. Although some may be, the EMA has provided a list of items within these sections which are not considered CCI/CBI. This includes:

  • Unit measurements, study IDs, names & addresses, vendors, sponsors, standard operating procedures (SOPs), study site IDs
  • Structural formulas, lot #’s, excipients, high level safety info, cell lines or strains, storage & shipping conditions, temp, humidity & other storage information
  • Methods, drug concentrations, quantification limits, scientific advice received from regulators, information on technical methodology (ELISA, LC-MS etc.)

Finally, every study contains insights to both internal procedures as well as clinically relevant information. These sections can usually be found within the protocol or methods, and often contain things such as primary & secondary endpoints, statistical methods, inclusion & exclusion criteria, literature reviews, plasma drug concentrations, and PK/PD models. Although these points can give insights into methods and techniques used by an organization, most regulatory bodies will deem this information relevant-enough to the research, and they will not accept this to be redacted as CCI/CBI (read this blog to learn more about EMA’s reasons to reject CCI).

How to Identify CCI/CBI in 3 Simple Steps

1. Is this information available in the public domain?

  • If this information can be searched for and found online via search engine, the company website, or previous publications, it is not confidential.

2. Does this information hold economic value?

  • If the disclosure of this information does not give a competitor some advantage within the market, this information is not CCI/CBI.

3. Is this information relevant for the understanding of the documents being published?

  • Some elements within a study may not be clinical, however they are still critical to understand it. This type of information requires further investigation but will often fall outside the scope of CCI/CBI.

Do you need help preparing anonymized and redacted reports for regulatory agency submissions that remove CCI/CBI? Our experts can partner with you to develop the identification criteria for a specific submission and manage the anonymization process, leaving a simplified review/approval step. Read more about our transparency and disclosure solutions here.

References

https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/external-guidance-implementation-european-medicines-agency-policy-publication-clinical-data_en-3.pdf

https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval/profile-public-release-clinical-information-guidance/document.html#s5

About the author

Honz Slipka
By: Honz Slipka

Honz Slipka is a Transparency Specialist II at Certara. With a research background in neuroscience, and experience in health information technology, Honz has a thorough understanding of data analysis, regulatory standards, and best practices in the field of clinical data privacy. Drawing from his experiences, Honz is a champion of innovation, helping to lead the field of science, healthcare, and research into the modern age of technological efficiency, clinical transparency, and data utility.