Clinical Trial Transparency and Regulatory Disclosure
When a pharmaceutical company initiates the application for marketing authorization of a medicinal product with the EMA, it may include certain data or information that is considered commercially confidential. This could include proprietary information, such as detailed manufacturing processes, formulation specifics, or commercial strategies that the company wishes to keep confidential and which may impact the economic interests and competitive position of the study sponsor.
To protect such commercially sensitive information, the EMA has established guidelines for study sponsors to protect and safeguard CCI. These guidelines aim to balance the need for transparency and public access to information with the protection of the legitimate interests of pharmaceutical companies.
During the evaluation and review of the marketing authorization application, the EMA assesses the CCI provided by the applicant. The agency confirms that only non-confidential information is made available publicly, while the CCI remains protected.
It's important to note that the specific procedures and guidelines related to the handling of CCI may be subject to updates and revisions over time. For the most accurate and up-to-date information, it is recommended to consult the EMA's official documentation and guidelines related to commercially confidential information.
In the context of Clinical Trial Regulation and the Clinical Trial Information System (CTIS), Commercially Confidential Information (CCI) refers to proprietary or commercially sensitive information submitted by a sponsor or applicant that they consider confidential and do not want to be disclosed to the public.
The CTIS is a centralized European database that has been developed to support the implementation of the EU Clinical Trials Regulation (536/2014). It aims to streamline the submission, assessment, and reporting of clinical trial data within the European Union.
Under the EU Clinical Trials Regulation, certain information related to clinical trials will be publicly accessible through the CTIS. However, sponsors or applicants can request that specific information they have deemed CCI be treated as CCI by the EMA to protect their commercial interests. This may include details such as the investigational medicinal product, manufacturing processes, formulation, or other proprietary information.
The EMA, with acceptable justification, will allow sponsors or applicants to indicate which information they consider commercially confidential during the submission process.
The exact procedures and guidelines related to CCI in the context of the CTIS are defined in the guidance documents developed by the European Medicines Agency (EMA) and the European Commission. These documents provide specific instructions on how to handle and protect commercially confidential information within the CTIS.
In the context of the European Medicines Agency (EMA) Policy 0070, Commercially Confidential Information (CCI), as with CTR, refers to proprietary or commercially sensitive information provided by pharmaceutical companies during the regulatory submission process. EMA Policy 0070 addresses the disclosure of clinical trial data for the purpose of transparency.
EMA Policy 0070 allows pharmaceutical companies to submit redacted clinical study reports (CSRs) as part of the marketing authorization applications. However, there may be certain types of information that companies consider commercially confidential under the regulators definition and guidelines and therefore does not want to be publicly disclosed.
Under Policy 0070, CCI refers to information that is proprietary to the company and, if disclosed, could harm its competitive position or commercial interests. This can include details such as manufacturing processes, formulation specifics, or commercialization strategies that the company wishes to keep confidential.
To protect CCI, EMA provides a mechanism for companies to request redactions or restrict access to specific information in the submitted documents. Companies are required to provide justifications for the requested redactions, explaining why the information meets the criteria for being commercially confidential.
EMA evaluates these requests and determines whether the information qualifies as commercially confidential. If approved, the requested information is redacted or restricted in the released documents to maintain the confidentiality of the proprietary information.
The aim of EMA Policy 0070 is to balance the transparency and public access to clinical trial data with the protection of commercially sensitive information. It ensures that the disclosure of clinical trial data strikes a balance between the public interest and the legitimate interests of the pharmaceutical companies.
Study sponsors will redact the confidential information in the documents accessible for public access. Redaction involves selectively removing or obscuring specific details from the submitted documents to protect commercially sensitive information. The redaction process ensures that the confidential information is not disclosed to the public, while still allowing for transparency in the overall clinical trial data. As noted above, EMA's Policy 0070 requires justification of CCI references within the document in addition to pre-approval from the EMA.
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