Today (04-November-2022) European Medicines Agency, released updated guidance on "Anonymisation of Protected Personal Data and assessment of Commercially Confidential Information during the preparation of RMPs " to assist companies in the retention/removal of Protected Personal Data (PPD) and identification of Commercially Confidential Information (CCI) where the update is related to the main body and annexes 4 and 6.
Anonymisation is a process of rendering data into a form that does not identify individuals and where identification is not likely to take place.
Protected Personal Data (PPD):
“Personal data” shall mean any information relating to an identified or identifiable natural person ('data subject'); an identifiable person is one who can be identified, directly or indirectly, in particular by reference to an identification number or to one or more factors specific to his physical, physiological, mental, economic, cultural or social identity.
Commercially Confidential Information (CCI):
CCI shall mean any information contained in the clinical reports submitted to 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.
The proposed changes in this guidance are all editorial and should be incorporated into the final RMP version during the scientific review process.