The European Medicines Agency (EMA) yesterday (26 April, 2024) released an updated guidance on the "Anonymisation of protected personal data and assessment of commercially confidential information during the preparation of Risk Management Plans".
The purpose of this guidance is to provide applicants and marketing authorization holders (MAHs) with general information on retaining/removing personal data (PD) and identifying commercially confidential information (CCI) when drafting risk management plans (RMPs) during pre-approval, as well as when drafting the RMPs for publication after approval.
Anonymising or removing PD/CCI information from the RMP allows EMA to publish the RMP postapproval without further redaction. The latest RMP submitted for evaluation at the time of CHMP opinion is considered the final RMP and will be published on the EMA product page.
Anonymisation of Protected Personal Data (PPD)
PPD refers to personal data that must be protected under data protection regulations. The guidance aims to ensure that PPD included in RMPs is anonymised to protect the privacy and rights of individuals. The general Anonymisation Methods include aggregation, masking, and pseudonymisation.
Assessment of Commercially Confidential Information (CCI)
CCI refers to information that is commercially sensitive and could harm the competitive position of a company if disclosed. The guidance aims to ensure that CCI included in RMPs is appropriately identified and protected and provides criteria for assessing whether information qualifies as CCI and should be protected.
After CHMP’s opinion, no further updates to the RMP are permitted, as there is no formal procedure to evaluate a new submission after the opinion and before the European Commission's decision. If a closing sequence for the electronic common technical document (eCTD) is planned, then the final RMP should also include the closing sequence in it. No CCI is expected to be present in the RMPs.
In the CHMP outcome documents, the applicant/MAH is requested to send three files to EMA via EudraLink:
1. The (redacted) RMP file.
2. An RMP file showing the redaction proposals (see-through boxes).
3. The signed declaration for the RMP publication, see the template.
PD and/or CCI in the RMP document that were not addressed during its drafting and evaluation will be redacted after the opinion is issued.
Check out the examples, and the most frequent issues regarding the redacted RMP that require interaction with applicants/MAH by clicking this LINK.