In September 2023, the European Medicines Agency (EMA) relaunched its Policy 0070 on publication of clinical data for medicinal products for human use (the Policy). The Policy, as discussed in previous posts, is one of the Agency’s flagship public health initiatives focused on promoting the transparency of both EMA decision-making and clinical data, sharing of knowledge and use in future research.
While the Policy was adopted by the EMA back in 2014, it has been suspended since 2018 due to the EMA’s relocation to Amsterdam and COVID-19. During the COVID-19 pandemic, the EMA adopted exceptional transparency measures for centrally approved COVID-19 vaccines and treatments. This was deemed a success further showing the need for clinical data sharing and, thus, the need for relaunching the Policy.
Reminder on Policy 0070
The Policy governs how EMA collects, reviews and publishes on a dedicated portal clinical data submitted by applicants and Marketing Authorization Holders (MAHs) in support of certain regulatory applications through the centralized procedure.
The published clinical data includes clinical overviews, clinical summaries, clinical study reports, protocols, sample CRFs and information on the statistical methods used. While the Policy also foresees the publication of patient-level data (IPD), the information provided by the EMA during the re-launch webinar, suggests that the publication of IPD is unlikely to start any time soon.
Commercially Confidential Information
The Policy allows the redaction of commercially confidential information (CCI) from clinical data prior to publication. For this purpose, the applicant/MAH must submit a proposal of a redacted clinical documentation together with relevant justifications for each proposed redaction. If approved by the EMA, a final redacted version will then need to be submitted.
For information to be considered CCI, it must not be publicly available, must present innovative features, and its disclosure must (i) not be in the public interest; and (ii) harm the applicant/MAH’s economic or competition position. To guide on this matter, the Policy contains a non-exhaustive list of information that may be considered CCI (e.g., clinical development programme or assay details), and guidance is available on what may not (e.g., information relevant to understand the reliability of the data or the safety of the product).
The EMA is also reportedly working on additional guidance to address potential conflicts between the transparency requirements of the Clinical Trials Regulation and the Policy.
Relaunching Policy 0070
The Policy remains unchanged in content and has only undergone procedural changes (i.e., EMA must now publish redated clinical reports within 120 days from the Committee for Medicinal Products for Human Use (CHMP) opinion, and no longer within 60 days from the issuance of a European Commission Decision; and submission deadlines for redaction proposals have been extended).
Procedures starting after September 2023
The relaunch of the Policy will be done gradually for procedures starting after September 2023:
– Phase 1: As of September 2023, only clinical data submitted in support of initial Marketing Authorization Applications (MAAs) containing new substances with a positive or negative CHMP opinion and withdrawal applications will be made public. Clinical data related to COVID-19 and other public health emergencies continue to be made public as previously.
– Phase 2: At a point of time to be determined in 2024, clinical data submitted in support of other application (i.e., extensions of indications and line extensions applications) will start to be made public.
Procedures that started before September 2023
The EMA intends to publish data relating to applications that remained unpublished during the Policy suspension period. However, in a letter sent in September 2023 to the European Ombudsman (EO) in response to questions raised by the latter, the EMA did not commit as to when this will be done, due to the significant volume of data this represents and the related resources considerations. The EMA informed the EO that an overall strategy is being developed and that it will be subject to stakeholder consultation.
EMA is providing guidance to applicants/MAHs to facilitate compliance with the Policy. It offers pre‑submission meetings and will individually specify the documents applicants/MAHs are expected to submit, as well as the deadlines for doing so, which will depend on the type of application.
The EMA has already published new guidance on the eSubmission and a Questions & Answers on the existing external guidance. The Agency will develop additional guidance, as well as a revised template of the anonymisation report that is currently under preparation.
Meanwhile, applicants and MAHs must continue to follow closely EMA updates on the implementation of the Policy. It is worth noting that the EMA pointed out in the letter sent to the EO that the scope of the Policy could be extended in the future to products containing known active substances.