Relaunch of Policy 70
EMA’s Policy 70 became effective in 2015 with the aim of ‘protecting and fostering public health’ by increasing transparency through the publication of clinical data composed of clinical reports and individual patient data (IPD) submitted under the centralised marketing authorisation procedure.
Policy 70 was later suspended for all products in 2018 as part of the EMA Business Continuity Plan due initially to the relocation of the EMA due to Brexit, and subsequently due to the Covid-19 pandemic, with the exception of treatments and vaccines for Covid-19, where clinical data has been published.
Policy 70 was relaunched September 2023, with the scope of the policy revised for non-Covid products to only be applicable to New Active Substances (NAS) submitted under the centralised marketing authorisation procedure. The relaunch focussed only on publication of clinical reports, with no requirement to publish individual patient data (IPD) that will be considered under a future Phase 2 of Policy 70 implementation. The clinical reports, referenced to as the Clinical Data Publication (CDP) package, comprise the clinical overviews (as submitted in module 2.5), clinical summaries (as submitted in module 2.7) and the clinical study reports with the appendices containing the protocol and protocol amendments, sample case report forms and documentation of statistical methods. The Policy 70 scope applies to all Marketing Authorisation Applications (MAAs) for which CHMP have adopted an opinion, including negative and withdrawn applications.
EMA confirm that for MAAs approved in the interim period between the initial suspension of Policy 70 and the September 2023 relaunch, Policy 70 will not be applied retrospectively and therefore there is no requirement to provide the CDP package for these applications, meaning Policy 70 is only applicable for MAAs that reached CHMP opinion from September 2023.
As part of the relaunch, the review process is unchanged but the EMA have extended the timelines for the publication of data for all products in scope, as follows;
- MAAs; 60 days after the European Commission decision and following publication of the European Public Assessment Report
- Article 58 Applications; within 150 days after the CHMP opinion.
- Withdrawn applications; within 150 days after the receipt of the withdrawal letter.
Specific invitation letters are sent by the EMA to request the CDP package for all applications that are in scope of Policy 70. The invitation letter will be sent less than 90 days before the planned CHMP opinion date and contains a list of documents in scope alongside a submission checklist with submission timelines and the relevant guidance. Importantly, the Marketing Authorisation Holder (MAH) will be offered the opportunity to attend a targeted CDP package pre-submission meeting. The meetings will be aimed at Small and Medium Size Enterprises (SME) and any company asked to submit a CDP package for the first time. The meeting can be used to discuss the scope of the CDP package and will advise on anonymisation of the data to ensure protection of personal data.
The meeting will also offer the MAH the chance to discuss the protection of Commercially Confident Information (CCI). CCI is defined as information contained in clinical reports submitted to the EMA that is not in the public domain and where disclosure may undermine the legitimate economic interest of the MAH. The EMA advises that CCI is not ordinarily expected to be seen in clinical documents, and based on the experience with Covid products, only a very small percentage of CCI redactions were accepted. EMA acknowledges that there may be limited circumstances where redaction is required, such as detailed manufacturing or assay information, or candidate products that have not been further developed. Any proposed redactions will require detailed justification that the definition of CCI applies and confirmation that such information is not already in the public domain.
An external guidance document is available that covers the scope of Policy 70, the procedural aspects, anonymisation and identification and redaction. Additionally, a Q&A document has been published on practical aspects including timelines and covers CCI and anonymisation and will be updated on a regular basis with any updates tracked. These documents detail the 84 day end-to-end process for the publication of the clinical reports.
EMA have maintained their working collaboration with Health Canada who have adopted a similar policy and joint review of the CDP package is possible if requested by the MAH. The agencies have developed an Anonymisation Report Template that can be used for all data packages within the EU and Canada, to reduce workload and duplication.
Critically, EMA acknowledges the additional obligations that Policy 70 places on applicants, with CDP package requests occurring at a timepoint when the MAA procedure itself can be extremely resource intensive. EMA actively encourages MAHs to reach out with queries and to utilise the CDP package pre-submission meetings to facilitate a smooth process.
How can S-cubed help you?
S-cubed are able to support clients in the preparation for and attendance at a pre-submission meeting as well as the preparation and submission of the CDP package, including advice on redaction of personal data and CCI.
Any Questions?
If you have any questions on this topic, please don’t hesitate to ask! You can contact us via email (info@s-cubed-global.com), and telephone (S-cubed Ltd: +44 1235 77 22 60).
Links
EMA Clinical Data Publication Guidance and Templates
Clinical Data Website