In 2023, the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) agreed to update the guidance which had been adopted in 2012 defining the common approach on what should be considered as personal data (PD) and commercially confidential information (CCI) in the MAA dossier of medicinal products for human use. Based on the experience gained by applying the principles set out in the first version of the present guidance document in 2012, it became apparent that the guidance and its annex needed to be updated. The objective remains to continue to facilitate a common and consistent approach across the European Economic Area (EEA) to provide guidance on the identification of PD that must be protected and CCI included in the MAA dossier.
This guidance document is intended to apply to information/documents on medicinal products for human use, for which the procedure has been finalised under the national, mutual recognition, decentralised and centralised procedures.
By extension, it is also intended to cover documents concerning the variation of the MA or documents containing information pertaining to the MAA dossier or documents linked to the aforementioned applications.
When it comes to disclosure of information/documents, the decision lies with the EMA/NCA. Third parties shall be informed or consulted as needed depending on respective national and European legal frameworks.
This guidance addresses the shared approach to be taken as high-level principles when providing access to different information/documents in the MAA dossier and follows the structure of the Common Technical Document (CTD) according to Volume 2B Notice to Applicants Medicinal products for human use/ICH M8 Electronic common technical document (eCTD) v4.0 draft ICH implementation guide v2.0 –cientific guideline (CHMP/ICH/143002/2015).
It is intended to be a consensus document agreed by the whole network of national competent authorities (NCAs) of the EEA for the disclosure of information/documents regarding medicinal products for human use (i.e., not applicable to medicinal products for veterinary use or medical devices) and lays down practical orientations for national and European authorities regarding the disclosure of the MAA dossier while providing adequate protection such as commercially confidential information and personal data. Notwithstanding this guidance document, it should be noted that EMA/NCA has to follow their European/national legislation on transparency and data protection (pursuant to Regulation (EU) 2016/679, Regulation (EU) 2018/1725 and any other relevant national data protection legislation applicable to NCAs, respectively).
In the following sections, the agreed principles on PD and CCI are presented, including guidance on whether such information can be disclosed.
Any information identified as PD or CCI must be subject to a preliminary review by the EMA/NCA prior to the possible disclosure of the information/documents.
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