EMA, HMA overhaul guidance on data transparency in MAAs
The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) on Wednesday announced a revised guidance aimed at creating a consistent approach for identifying commercially confidential information (CCI) and personal data (PD) in marketing authorization applications (MAAs) for human medicines.The revision represents a “comprehensive overhaul” of the regulators’ guidance on the matter and comes more than a decade after the initial guidance was released in 2012. It also specifies “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.”
The guidance includes minor revisions from a draft released in March 2024. According to the announcement, nine companies, associations, and other organizations provided feedback on the draft and expressed their support for the HMA/EMA initiative. A report analyzing the comments from the public consultation will be published at the beginning of 2025.
The guidance outlines fundamental principles on PD, including data related to experts or designated personnel with legally defined responsibilities, PD related to staff with no legally defined responsibilities, individuals enrolled in clinical trials and data concerning drug safety.
It states that the qualified person (QP), qualified person responsible for pharmacovigilance (QPPV), the investigator/principal investigator, coordinating investigator, and the sponsor’s signatory have legally defined responsibilities and roles with respect to the MAA and “it is in the public interest to disclose their names.”
Yet applicants are advised that non-essential information about these individuals, such as personal addresses, e-mail addresses, and personal phone numbers is protected information and should not be included in the MAA dossier.
It outlines principles for redacting CCI related to information about the drug's quality and manufacturing processes, its composition and formulation, the active ingredient, the final product, non-clinical and clinical data, and inspection information.
The guidance includes an annex that discusses the information that may be classified as protected personal data (PPD) or CCI in the MAA submitted in the five modules of the International Council on Harmonization's (ICH) Common Technical Document (CTD).
Since 2012, EMA and the national competent authorities “have gained experience in handling access-to-documents requests and over the years, they have applied further transparency when releasing data. This made it necessary to review the guidance on CCI to align it with day-to-day practice and to ensure all authorities continue to follow a harmonised approach,” the regulators said.
Revised Guidance, Announcement
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